Tag Archives: HbA1c

Diabetes: ‘Gold Standard’ HbA1c Test Not So Great For Dialysis Patients ‎

In situations where rapid changes occur in blood sugar, the glycated albumin (GA) test gives a more accurate picture of diabetes control

BLOOD sugar monitoring is a vital part of diabetes management. Patients and physicians rely on the hemoglobin A1c (HbA1c) test to measure an individual’s average blood sugar level over the prior three months. It is the most commonly used long-term blood sugar test, and the gold standard for the medical community.

While the American Diabetes Association has deemed the HbA1c test an effective tool for diagnosing diabetes, kidney doctors recently determined that the HbA1c is not as useful for managing patients with diabetes and advanced kidney failure. Another test, the glycated albumin or GA assay, appears to be far more effective in this setting, they say.

The GA test, developed by Tokyo-based Asahi Kasei Pharma Corporation, measures blood sugars over the past 17 days, as opposed to the longer time frame for HbA1c. In situations where rapid changes occur in blood sugar, the GA gives a more accurate picture of diabetes control. The GA test used in this study is available in Japan, China and South Korea, but is not yet FDA approved in the United States.

According to a new study at Wake Forest Baptist Medical Center, which appears online in the Clinical Journal of the American Society of Nephrology and is scheduled for the July print issue, many organs don’t function properly in severe kidney failure. For example, most dialysis patients have anemia with fewer red blood cells than they should, which has a dramatic impact on the accuracy of the HbA1c reading.

Hemoglobin inside red blood cells carries oxygen in the body. Blood sugar chemically interacts with the hemoglobin to identify a value for HbA1c. But HbA1c results are only accurate when red cells have a normal lifespan. Dialysis patients have shorter red cell survival, reducing the time that sugar in the bloodstream has to interact with hemoglobin, and causing lower HbA1c values.

“Doctors long thought the HbA1c predicted outcomes in diabetes. This test is not predictive of outcomes in diabetes patients with kidney disease on dialysis. Dialysis patients and physicians get a false sense of security because their lower HbA1c actually relates to shorter red cell survival, yet suggests diabetes control is better than it really is,” explained Barry I. Freedman, M.D., John H. Felts III Professor and lead investigator.

“This is the first study showing that a blood sugar test predicts risk of death in diabetic dialysis patients, as well as risk of hospitalization,” Freedman said. “This test provides the missing link that will allow dialysis patients and physicians to accurately gauge risk. The association is clear: high GA readings predict higher risk.”

Freedman and colleagues evaluated 444 patients with diabetes undergoing dialysis. Patients continued their normal treatment and HbA1c monitoring, but also agreed to have a GA test every three months for an average of more than 2.3 years.

Wake Forest Baptist researchers compared the patients’ HbA1c and GA test results, assessing their ability to predict hospitalizations and survival. They found that the HbA1c failed to predict these important medical outcomes. In contrast, the GA was a strong predictor of patient survival and hospitalizations.

Nearly 500,000 people are on dialysis in the Unites States and diabetes is the cause of kidney failure in nearly 50 percent of them. Diabetes is the most common cause of kidney failure worldwide and is associated with high mortality rates – more than 20 percent of dialysis patients die each year. As such, there is an urgent need for accurate blood sugar testing in diabetic dialysis patients.

Freedman suggests physicians not rely on the HbA1c in dialysis patients, instead suggesting that blood glucose levels be directly monitored with multiple daily readings until the GA test is available in the states.

The GA test is not limited only to dialysis patients. Some studies have shown that shorter-term markers for glucose control may lead to better management of glucose than longer-term measures with the HbA1c test. So, instead of waiting 3-6 months for an HbA1c test, which is the current recommendation, the rapid and inexpensive GA test could be performed monthly.

Several studies have confirmed that measurements of GA and HbA1c are closely correlated. Though the GA test has been available in labs for years, Epinex Diagnostics, the developer of the rapid result GA measurement called G1A™, believes the mounting scientific evidence that supports GA testing will eventually gain wide acceptance among professionals. Numerous studies show the need for a mid-range test that could be performed monthly as another means of helping people with diabetes manage their glucose levels more effectively.

Sources: Wake Forest Baptist Medical Center, Epinex Diagnostics

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Type 2 Diabetics Experience Hyperglycemia Throughout The Day

POSTPRANDIAL (after meals) hyperglycemia is one of the earliest abnormalities of glucose homeostasis associated with type 2 diabetes and is markedly exaggerated in diabetic patients with fasting hyperglycemia. And research conducted with human patients, mice, and pancreas beta cell cultures all point to a single threshold at which elevated blood sugars cause permanent damage to your body: 140 mg/dl (7.8 mmol/l) after meals.

Better control of postprandial blood glucose levels contributes more to improvement in HbA1c levels than fasting glycemic control. And since HbA1c is the gold standard for determining glycemic control among people with both type 1 and type 2 diabetes, all diabetics struggle to control the blood sugar round-the-clock.

However, a new research study from The Netherlands suggests that diabetics face a Sisyphean task ‒ postprandial hyperglycemia is highly prevalent throughout the day in type 2 diabetes patients, including even those patients with HbA1c well below 7.0%.

Although postprandial hyperglycemia is recognized as an important target in type 2 diabetes treatment, information on the prevalence of postprandial hyperglycemia throughout the day is limited. The researchers therefore assessed the prevalence of hyperglycemia throughout the day in type 2 diabetes patients and healthy controls under standardized dietary, but otherwise free-living conditions.

The researchers recruited 60 male type 2 diabetes patients (HbA1c 7.5 ± 0.1%) and 24 age- and BMI-matched normal glucose tolerant controls to participate in a comparative study of daily glycemic control. During a 3-day experimental period, blood glucose concentrations throughout the day were assessed by continuous glucose monitoring (CGM).

The researchers discovered that type 2 diabetes patients experienced hyperglycemia (glucose concentrations > 180 mg/dl [10 mmol/l]) 38 ± 4% of the day. Even diabetes patients with an HbA1c level below 7.0% (53 mmol/mol) experienced hyperglycemia for as much as 24 ± 5% throughout the day. Hyperglycemia was negligible in the control group (3 ± 1%).

After evaluating the data, the researchers concluded that hyperglycemia is highly prevalent throughout the day in type 2 diabetes patients, including even those patients with HbA1c well below 7.0%. More importantly, “standard medical care with prescription of oral blood glucose lowering medication does not provide ample protection against postprandial hyperglycemia,” the authors wrote.

The aim of every diabetic is to keep postprandial blood sugar levels in line with the recommendations of the American Association of Clinical Endocrinologists, an organization of specialists who treat diabetes, that blood sugar should not be allowed to rise above 140 mg/dl two hours after a meal. The International Diabetes Federation (IDF) has also adopted the 140 mg/dl post-meal blood sugar target.

Since, as Dutch study shows, a majority of patients with diabetes fail to achieve their glycemic goals, it means elevated postprandial glucose (PPG) concentrations contribute to suboptimal glycemic control.

What is the contribution of PPG to the long-term complications of diabetes? Many studies have demonstrated a positive association between diabetic complications and hyperglycemia. “Complications” is a euphemism for some very ugly outcomes that include blindness, amputation, kidney failure and death. Considering the interrelationships among glycemic measures, this is not surprising.

A team of Italian researchers led by A Gastardelli started examining beta cell response to glucose in people with normal blood sugars discovered that a small amount of beta cell dysfunction began to be detectable in people whose blood sugar rose only slightly over 100 mg/dl on a 2-hour glucose tolerance test. The beta cells are the cells in the pancreas that produce the insulin your body uses to control your blood sugar.

Analyzing their data further, they found that with every small increase in the 2-hour glucose tolerance test result, there was a corresponding increase in how much beta cell failure was detectable. The higher a person’s blood sugar rose within “normal” range, the more beta cells were failing.

In another study, University of Utah neurologists found that patients who were not known to be diabetic, but who registered 140/mg or higher on the 2-hour sample taken during a glucose tolerance test were much more likely to have a diabetic form of neuropathy than those who had lower blood sugars. Even more telling, the researchers found that the length of time a patient had experienced this nerve pain correlated with how high their blood sugar had risen over 140 mg/dl on the 2-hour glucose tolerance test reading.

It is important to note that this study also showed that only the glucose tolerance test results corresponded to the incidence of neuropathy in these patients, not their fasting blood sugar levels or their results on the HbA1c test. This is significant because most American doctors do not offer their patients glucose tolerance tests, only the fasting glucose and HbA1c tests that fail to diagnose these obviously damaging post-meal blood sugars.

Given facts such as these, what does a diabetic do? Jenny Ruhl suggests that if your blood sugar has been very high for a while, you can bring down the levels by proceeding in stages, setting your blood sugar targets progressively lower, a step at a time. But don’t stay at higher than normal levels for any longer than is absolutely necessary. Once your body does adapt, you will probably feel much better and much more energetic than before.

Ruhl recommends patience while your body becomes accustomed to new, healthy, blood sugar levels, cautioning not to respond to feeling as if you were having a hypo by eating carbs to push up your blood sugar as long as your blood sugar tests at 80 mg/dl (4.4 mmol/l) or above. Give your body a chance to adapt and eventually you will feel completely normal when you have a normal blood sugar and may feel surprisingly toxic when your blood sugar reaches the dangerously high levels that you used to feel normal at, she says.

The 140 mg/dl (7.8 mmol/L) blood sugar target is a good start, but many of us find we feel better and get even more normal health if we shoot for truly normal blood sugars and keep our blood sugar under 120 mg/dl (6.7 mmol/L) at all times. If you can do it, go for it. Now that we know that heart attack risk rises significantly at HbA1c in the mid 5% range, getting to true normal is that much more important, Ruhl concludes.

Looking Beyond HbA1c: Research To Find New Diabetes Biomarkers Gains Traction

The discovery of several new biomarkers in the blood may further our understanding of exactly who’s at risk for diabetes

BETA cells within the pancreas produce and release insulin. Loss of the function of these cells compromises the body’s ability to control blood sugar and underlies the development of diabetes. So, one of the next frontiers of diabetes therapeutics is to change the progression rate of beta cell failure.

Recognizing this as a research priority, the Foundation of the National Institutes of Health (FNIH) Biomarkers Consortium announced Tuesday the launch of a multi-year clinical study to improve tools for measuring the function of insulin-producing beta cells in people with type 2 diabetes mellitus. Researchers hope the initiative will lead to improved techniques for tracking progression of the disease and pave the way for more effective treatments.

The project ‒ “Diabetes Drug Development: Identification and Validation of Markers that Predict Long-Term Beta Cell Function and Mass” ‒ is being managed by the Metabolic Disorders Steering Committee (MDSC) of the FNIH Biomarkers Consortium.

It is a three-year, $5.1 million clinical study to standardize tests for measuring beta cell function in the clinical setting that aims to improve methods for the early prediction of the long-term response to an intervention and for identification of patients at risk for rapid beta cell function deterioration, thereby enabling future clinical studies that examine diabetes progression.

A biomarker is a biochemical feature or facet that can be used to measure the progress of disease or the effects of treatment. So the validation of biomarkers to measure the progression of diabetes will greatly facilitate the development of better medicines to treat and potentially prevent this disease and its often disabling complications.

Experts believe biomarkers will become one of the major driving forces of pharmaceutical research and drug development in the coming years.

Currently, diabetes researchers are working without the benefit of agreed-upon standards for gauging beta cell function and this initiative will give researchers practical tools that can be used to measure beta cell function over time and stimulate research to maintain and improve that function.

The project was developed through a rigorous consensus-building process by a team of experts from across the entire scientific community. The pharmaceutical industry, academic, and government representatives contributed their clinical trials expertise and scientific support to the design and execution of the studies.

Utilizing a collaborative approach, the FNIH Biomarkers Consortium has brought together diabetes experts from the National Institutes of Health (NIH), Food and Drug Administration (FDA), leading academic institutions, the pharmaceutical industry, and non-profit sector to develop the project.

Biomarkers play an integral part in conducting clinical trials and treating patients. In most instances, they help medical practitioners, researchers, and regulatory officials make well-informed, scientifically sound decisions.

However, in clinical studies, there is often uncertainty in how much weight to place on biomarker results versus clinical outcomes. This uncertainty emanates from opposing goals of the drug approval process. On one hand, the process must ensure that all therapeutics tested are safe and that the benefits outweigh the risks. On the other hand, the process should allow therapies to be accessible to patients as quickly as reasonably possible.

Judicious use of biomarkers in the drug development process can bring these goals into alignment. More efficient discovery and use of biomarkers in the development of anti-diabetes drugs will depend on advancing current understanding of the pathogenesis of diabetes and especially its macrovascular (pertaining to the larger blood vessels) complications.

The idea of using biomarkers to predict diabetes is not entirely new. Glycated hemoglobin (HbA1C) values are now routinely being monitored to screen for at-risk patients. A study published in PLoS One last year shows that several new biomarkers in the blood may further our understanding of exactly who’s at risk for diabetes, and increase our knowledge of the etiology of the disease.

Veikko Salomaa and colleagues from the Department of Chronic Disease Prevention at the National Institute for Health and Welfare in Helsinki, Finland, tested nearly 13,000 people and found almost 600 cases of diabetes during routine follow-up exams.

According to the study, low levels of adiponectin, and high levels of apoB, C-reactive protein (CRP), and insulin, increase the chance that a woman will develop diabetes. When these factors were measured, proper diabetes prediction increased by 14% compared to when doctors only use classic risk factors, such as BMI and blood glucose levels, to predict disease.

The biomarkers that best predicted diabetes in men were low adiponectin, and high levels of CRP, interleukin-1 receptor antagonist (IL-1RA), and ferritin. Accounting for these biomarkers led to a 25% increase in correct diabetes detection in the cohort. Adiponectin is a hormone found in the body that modulates a number of metabolic processes, including glucose regulation and fatty acid catabolism.

The use of adiponectin, a hormone derived from fat cells, which is abundant in plasma and easy to measure through commercially available kits, was also confirmed as a robust biomarker predictive of glycemic efficacy in Type 2 diabetes and healthy subjects, after treatment with peroxisome proliferator-activated receptor-agonists (PPAR), but not after treatment with non-PPAR drugs such as metformin by the first project to be completed by the Biomarkers Consortium.

The project conducted a statistical analysis of pooled and blinded pre-existing data from Phase II clinical trials contributed by four pharmaceutical companies and analyzed under the direction of a diverse team of scientists from industry, the National Institutes of Health (NIH), U.S. Food & Drug Administration (FDA), and academic research institutions.

Source: FNIH Biomarker Consortium

“Normal” Blood Sugar Levels May Still Mean You Have Prediabetes

FPG between 91 and 99 mg/dl is a strong independent predictor of type 2 diabetes, claims new study

Type 2 diabetes is a lifestyle disease in which the body no longer responds appropriately to the hormone insulin, which helps ferry sugar from the blood into our cells after a meal. When fasting blood sugar levels reach 126 mg/dl or more, doctors will diagnose diabetes

Prediabetes means that your blood sugar level is higher than normal, but it’s not yet increased enough to be classified as type 2 diabetes. Still, without intervention, prediabetes is likely to become type 2 diabetes in 10 years or less. (Scroll to end for Prediabetes FAQs)

Traditionally, blood sugar levels below 100 mg/dl have been considered “safe”, whereas levels between 100 and 126 signal a “higher risk” of diabetes (prediabetes). But according to the new study by Dr. Paolo Brambilla and colleagues at the University Milano Bicocca in Italy, the currently accepted “normal” blood sugar range might be too wide.

“FPG (Fasting Plasma Glucose) between 91 and 99 mg/dl is a strong independent predictor of type 2 diabetes and should be used to identify people to be further investigated and aided with preventive measures,” the researchers say. The conclusion significantly expands the “prediabetes” label.

To back their claim, the researchers report that in the course of their study they discovered people at the high end of what’s considered the “normal” blood sugar range are twice as likely to get the disease as are those in the low end. The findings are in line with an earlier study from Oregon, and the Italian researchers say they can help identify the people who need extra medical attention.

The researchers looked at data for nearly 14,000 men and women who’d had blood drawn several times at their clinic. The patients were between 40 and 69 years old and all of them had normal blood sugar levels at first. Over the next seven to eight years, on average, about two percent of the women and nearly three percent of the men developed diabetes.

Less than one percent of those who started out with fasting blood sugar levels between 51 and 82 mg/dl wound up with the disease, while more than three percent did so if they had values between 91 and 99. After controlling for other factors that might influence the likelihood of getting diabetes, that corresponded to a two-fold difference in risk of developing the disease.

Research has shown that if you have prediabetes, the long-term damage of diabetes — especially to your heart and circulatory system — may already be starting. If your blood sugar tests over 100 mg/dl fasting more than once, your fasting blood sugar is likely to go over the 125 mg/dl level used to diagnose full diabetes within 3 years.

More importantly, if your blood sugar is at 100 mg/dl fasting, it is very likely that your post-meal blood sugar is heading towards the diabetic range, which is over 200 mg/dl which is why your fasting blood sugar is deteriorating. High post-meal blood sugars kill beta cells. If you can bring down those post-meal highs, you may be able to prevent the beta cell death that is destroying your fasting control!

While opinion is divided on the question whether doctors should treat these people any different, as the researchers suggest, everyone agrees that people should strive to manage their weight and be physically active irrespective of what their blood sugar level is.

The bald reality is that, according to the American Diabetes Association, in the US alone there are three times as many prediabetics as people with diabetes (79:27 million). And It is estimated that there will be 418 million people worldwide with prediabetes by 2025.

How to Tell if You Have Prediabetes

The American Diabetes Association says while diabetes and prediabetes occur in people of all ages and races, some groups have a higher risk for developing the disease than others and warns that Diabetes is more common in African Americans, Latinos, Native Americans, and Asian Americans/Pacific Islanders, as well as the aged population. This means they are also at increased risk for developing prediabetes.

There are three different tests your doctor can use to determine whether you have prediabetes:

• The A1C test

• The fasting plasma glucose test (FPG)

• The oral glucose tolerance test (OGTT).

The blood glucose levels measured after these tests determine whether you have a normal metabolism, or whether you have prediabetes or diabetes.

If your blood glucose level is abnormal following the FPG, you have impaired fasting glucose (IFG); if your blood glucose level is abnormal following the OGTT, you have impaired glucose tolerance (IGT). Both are also known as prediabetes.

The American Diabetes Association Risk Test for Diabetes can help you determine if you are at increased risk for diabetes or prediabetes. A high score may indicate that you have prediabetes or at risk for prediabetes. Take the test and find out for sure.

ADA Prediabetes FAQs

What is prediabetes and how is it different from diabetes?

Prediabetes is the state that occurs when a person’s blood glucose levels are higher than normal but not high enough for a diagnosis of diabetes. About 11 percent of people with prediabetes in the Diabetes Prevention Program standard or control group developed type 2 diabetes each year during the average 3 years of follow-up. Other studies show that many people with prediabetes develop type 2 diabetes in 10 years.

What are the symptoms of prediabetes?

The reason why so many people suffer from prediabetes and are completely unaware of it is because it is quite possible for no symptoms to manifest themselves. Both diabetes and prediabetes develop at a gradual rate.

How do I know if I have prediabetes?

Doctors can use either the fasting plasma glucose test (FPG) or the oral glucose tolerance test (OGTT) to detect prediabetes. Both require a person to fast overnight. In the FPG test, a person’s blood glucose is measured first thing in the morning before eating. In the OGTT, a person’s blood glucose is checked after fasting and again 2 hours after drinking a glucose-rich drink.

How do I stop prediabetes developing into Type 2 diabetes?

The good news may be that, if you have become aware of the disease early, your condition can still be cured. The two principle factors for consideration are the changing of diet and the addition of appropriate physical exercise to your lifestyle. By making these changes, it may be possible to return blood sugar levels to normal. Prediabetes is a serious medical condition that can be treated.

The good news is that the recently completed Diabetes Prevention Program study conclusively showed that people with prediabetes can prevent the development of type 2 diabetes by making changes in their diet and increasing their level of physical activity. They may even be able to return their blood glucose levels to the normal range. But for a comprehensive and individual plan you should see your doctor.

Is prediabetes the same as Impaired Glucose Tolerance or Impaired Fasting Glucose?

Yes. Doctors sometimes refer to this state of elevated blood glucose levels as Impaired Glucose Tolerance or Impaired Fasting Glucose (IGT/IFG), depending on which test was used to detect it.

Why do we need to give it a new name? Has the condition changed?

The condition has not changed, but what we know about it has. We are giving IGT/IFG a new name for several reasons. prediabetes is a clearer way of explaining what it means to have higher than normal blood glucose levels. It means you are likely to develop diabetes and may already be experiencing the adverse health effects of this serious condition. People with prediabetes are at higher risk of cardiovascular disease. People with prediabetes have a 1.5-fold risk of cardiovascular disease compared to people with normal blood glucose. People with diabetes have a 2- to 4-fold increased risk of cardiovascular disease. We now know that people with prediabetes can delay or prevent the onset of type 2 diabetes through lifestyle changes.

How does the FPG test define diabetes and prediabetes?

Normal fasting blood glucose is below 100 mg/dl. A person with prediabetes has a fasting blood glucose level between 100 and 125 mg/dl. If the blood glucose level rises to 126 mg/dl or above, a person has diabetes.

How does the OGTT define diabetes and prediabetes?

In the OGTT, a person’s blood glucose is measured after a fast and 2 hours after drinking a glucose-rich beverage. Normal blood glucose is below 140 mg/dl 2 hours after the drink. In prediabetes, the 2-hour blood glucose is 140 to 199 mg/dl. If the 2-hour blood glucose rises to 200 mg/dl or above, a person has diabetes.

Which test is better?

According to the expert panel, either test is appropriate to identify prediabetes.

Why do I need to know if I have prediabetes?

If you have prediabetes, you can and should do something about it. Studies have shown that people with prediabetes can prevent or delay the development of type 2 diabetes by up to 58 percent through changes to their lifestyle that include modest weight loss and regular exercise. The expert panel recommends that people with prediabetes reduce their weight by 5-10 percent and participate in some type of modest physical activity for 30 minutes daily. For some people with prediabetes, intervening early can actually turn back the clock and return elevated blood glucose levels to the normal range.

What is the treatment for prediabetes?

Treatment consists of losing a modest amount of weight (5-10 percent of total body weight) through diet and moderate exercise, such as walking, 30 minutes a day, 5 days a week. Don’t worry if you can’t get to your ideal body weight. A loss of just 10 to 15 pounds can make a huge difference. If you have prediabetes, you are at a 50 percent increased risk for heart disease or stroke, so your doctor may wish to treat or counsel you about cardiovascular risk factors, such as tobacco use, high blood pressure, and high cholesterol.

Who should get tested for prediabetes?

If you are overweight and age 45 or older, you should be checked for prediabetes during your next routine medical office visit. If your weight is normal and you’re over age 45, you should ask your doctor during a routine office visit if testing is appropriate. For adults younger than 45 and overweight, your doctor may recommend testing if you have any other risk factors for diabetes or prediabetes. These include high blood pressure, low HDL cholesterol and high triglycerides, a family history of diabetes, a history of gestational diabetes or giving birth to a baby weighing more than 9 pounds, or belonging to an ethnic or minority group at high risk for diabetes.

How often should I be tested?

If your blood glucose levels are in the normal range, it is reasonable to be checked every 3 years. If you have prediabetes, you should be checked for type 2 diabetes every 1-2 years after your diagnosis.

Could I have prediabetes and not know it?

Absolutely. People with prediabetes don’t often have symptoms. In fact, millions of people have diabetes and don’t know it because symptoms develop so gradually, people often don’t recognize them. Some people have no symptoms at all. Symptoms of diabetes include unusual thirst, a frequent desire to urinate, blurred vision, or a feeling of being tired most of the time for no apparent reason.

Sources: American Diabetes Association, Diabetes Care, Diabetes UK

Diabetes Management: Analysis Shows Value of Structured Exercise Programs

Insurance Benefits for Exercise Programs Can Cut Health Costs

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FOR the person with type 2 diabetes, or the high-risk individual who is trying to prevent the development of diabetes, there is an enormous body of research literature documenting the benefits of exercise. Indeed, research shows that just six weeks of exercise is enough to change both brain chemistry and body chemistry for the better; diets alone don’t have the same effect. But some questions still remain ‒ how much exercise is needed, and what kind?

A host of studies have linked exercise programs with improved health measures related to blood pressure, lipid levels — including cholesterol and triglycerides — cardiovascular events, cognition, physical performance, premature death and quality of life. Analyses of interventions to promote physical exercise in adults have found that compared with no intervention, exercise programs are cost-effective and have the potential to improve survival rates and health-related quality of life.

A recent systematic review and meta-analysis ‒ undertaken by scientists led by Daniel Umpierre of the Hospital de Clinica de Porto Alegre in Brazil ‒ compares the association between physical activity advice and structured exercise programs, respectively, and markers of diabetes.  It reveals that implementing structured exercise training — including aerobic, resistance or both — is associated with a greater reduction in HbA1c levels for patients with diabetes compared to patients in control groups. Results of the study are published in the May 4 issue of the Journal of the American Medical Association (JAMA).

A structured exercise is a task, activity, or question posed by a leader that pushes everyone to reflect, focus, offer ideas and insights, and become engaged in learning. Structured exercises offer group leaders a variety of options for encouraging group participation and discussion, practicing skills, and involving adults who have a range of learning styles and capabilities.

After analyzing the results of 47 randomized clinical trials, the researchers also found that exercising for longer periods of time was better at bringing blood sugar levels down than exercising more intensively. Longer weekly exercise duration was also associated with a greater decrease in these levels, according to results of the analysis of previous studies.

The meta-analysis shows that greatest reductions in HbA1c occurred in patients exercising for more than 150 minutes in total per week. Exercise intensity did not appear to matter. Exercising a minimum of 150 minutes a week (usually broken down to 30 minutes of exercise five days a week) is recommended by such institutions as the American College of Sports Medicine.

“People with type 2 diabetes should engage in regular exercise training, preferentially supervised exercise training,” says Beatriz Schaan, the study’s senior author. “If these patients can perform training for more than 150 minutes per week, this would be more beneficial concerning their glucose control. However, if they cannot reach this amount of weekly exercise, lower exercise amounts are also beneficial.”

The Importance of Exercise in Diabetes Management

A recent joint statement from the American Diabetes Association (ADA) and the American College of Sports Medicine (ACSM) has already underscored the importance of physical exercise to prevent and manage insulin resistance, type 2 diabetes mellitus, gestational diabetes mellitus, and the complications of diabetes.

“Current guidelines recommend that patients with type 2 diabetes should perform at least 150 minutes per week of moderate-intensity aerobic exercise and should perform resistance exercise three times per week,” the authors of the Brazil study wrote. “Regular exercise improves glucose control in diabetes, but the association of different exercise training interventions on glucose control is unclear.”

Indeed, although some clinical trial evidence suggests that aerobic exercise and resistance training can each improve glucose control in patients with type 2 diabetes mellitus, not all clinical trials are consistent with regard to this finding.

However, differences in results of clinical trials about the ability of aerobic exercise and resistance training to improve glucose control are primarily due to differences in trial design, including modality, intensity, exercise program duration, adherence to the programs, sample size, and patient populations.

In the Brazilian study, the authors analyzed 47 randomized controlled trials (RCTs) into the effect of exercise on HbA1c, with a total of 8538 patients. In 23 of these RCTs, patients took part in structured exercise training, and in the other 24 they were simply given advice on physical activity.

Across all studies analyzed, engaging in structured exercise was associated with decreased HbA1c levels compared with controls, whether this was structured resistance training (fall in HbA1c of 0.57%), structured aerobic exercise (fall of 0.75%), or a combination of both (0.51% fall).

A longer total time spent in structured exercise was associated with better glycemic control. If total weekly time in structured exercise exceeded 150 minutes, the average drop in HbA1c was 0.89%, against 0.36% for a time of 150 minutes or less.

Physical activity advice was only associated with a decline in HbA1c if it was combined with dietary advice.

The authors said: “This systematic review and meta-analysis of RCTs demonstrates important findings regarding the prescription of structured exercise training. First, aerobic, resistance, and combined training are each associated with HbA1c decreases, and the magnitude of this reduction is similar across the three exercise modalities.

“Second … structured exercise of more than 150 minutes per week is associated with greater declines in HbA1c than structured exercise of 150 minutes or less per week in patients with type 2 diabetes. This finding is important because the current guideline-recommended exercise duration is at least 150 minutes per week.

They added: “Although high-intensity exercise has been previously shown to have an association with HbA1c reduction, our findings did not demonstrate that more intensive exercise was associated with greater declines in HbA1c.”

In an accompanying editorial, Marco Pahor, director of the University of Florida Institute on Aging, argues that “the meta-analysis … and cumulative evidence from a large number of randomized controlled trials conducted over the past few decades in the area of physical activity and exercise provide solid evidence for public policy makers to consider structured exercise and physical activity programs as worthy of insurance reimbursement to promote health, especially in high-risk populations.”

Insurance Benefits for Exercise Programs Can Cut Health Costs

With respect to type 2 diabetes, Medicare reimburses for approved self-management education and medical nutrition therapy programs. But no specific reimbursement is given for any physical activity or exercise program, despite evidence that such programs can help improve health and cut costs.

Questions remain as to what format reimbursable exercise and physical activity programs should take, what population group should be targeted, and at what stage of life or health status would a lifestyle intervention be most cost-effective to implement.

Some insurance providers already include a fitness benefit for members, such as monthly membership at certain fitness centers or access to personal trainers or exercise classes at reduced cost. Indeed, use of such health plan-sponsored club benefits by older adults has been linked to slower increases in total health care costs.

In one study, older adults who visited a health club two or more times a week over two years incurred $1,252 less in health-care costs in the second year than those who visited a health club less than once a week. Programs among people with lower incomes can also pay off, because people in that group are otherwise more likely to forego health-promoting physical activity because of economic constraints or safety concerns.

“People are willing to invest in improved health, but if you have a fixed amount of resources then you want to choose where you get the most health for the dollar,” said Erik Groessl, an assistant professor of family and preventive medicine at the University of California, San Diego, and director of the UCSD Health Services Research Center. Groessl was not involved in the current analysis.

Group training or walking programs, for example, can be cost-effective, sustainable forms of physical activity that don’t require expensive health care professionals or equipment. But more costly interventions that yield dramatic results might also be worth the expense.

“There is a lot of evidence that physical activity works, and I think it’s time to start putting it into practice more widely,” Groessl said.

Sources: JAMA, University of Florida News, Medpage Today

Diabetes Management: Telephonic CBT Counseling for Diabetics with Depression Can Improve Treatment Outcomes

A NEW investigative study by researchers at VA Ann Arbor Healthcare System and University of Michigan Health System shows that telephonic intervention can improve patients’ access to effective depression care, improve their cardiovascular health and get them moving again, reports Endocrine Web.

As is well known, depression is a common, treatable issue for many people who have diabetes but most busy clinics cannot provide the level of intensive care these patients need. In many cases this proves to be a major hurdle for diabetics in maintaining the strict medication regimen or exercise schedule.

Patients with diabetes and depression often have self-management needs that require between-visit support. The study evaluated the impact of telephone-delivered cognitive behavioral therapy (CBT) targeting patients’ management of depressive symptoms, physical activity levels, and diabetes-related outcomes.

3G Wireless Technology Delivers Diabetes Health Care In Innovative Project

The research team worked over a year to improve diabetes patients’ health by first addressing their depression. The program began with behavioral therapy sessions over the telephone with a specially trained nurse and later phased in a walking program. This was done because delivering therapy by telephone makes it feasible to reach large numbers of patients who may not attend traditional in-person appointments.

For the investigation, researchers divided a group of 291 participants with type 2 diabetes and significant depressive symptoms into two groups. One group received standard care, while the other segment was put through a year-long intervention program, which consisted of 12 weeks of cognitive behavioral therapy and nine months of supplemental phone checkups.

The findings ‒ published online ahead of print in Medical Care ‒ showed the intervention was successful in lowering patients’ blood pressure, increasing their physical activity by about four miles of walking per week and easing their depressive symptoms. At the end of the year, 58 percent of patients who received the intervention had depression symptoms that were in remission, compared to only 39 percent of the patients who did not receive counseling.

Even Telephonic Intervention Improves Diabetes Control

The cognitive behavior therapy helped the study participants address negative thought processes and behaviors that made it difficult for them to manage their diabetes and make healthy lifestyle choices.

The physical activity component of the program used pedometers to help patients set walking goals and monitor their progress. Earlier studies have shown that along with physical benefits, exercise also helps boost one’s mood.

Indeed, patients with depression and additional chronic medical conditions do better, as the study demonstrates, if their depression is addressed first, if it is addressed systematically, and if exercise is also encouraged.

Most patients entered the study with relatively good blood glucose control. So while the intervention did not lead to a drop in A1C ‒ a common measurement of blood glucose levels ‒ patients did see more than a 4-point improvement in their systolic blood pressure, walked about half a mile more per day and reported an improvement in their general quality of life.

“This study shows that telephone-delivered counseling can improve patients’ access to effective depression care, improve their cardiovascular health and get them moving again,” said lead author John Piette.

In view of this study, “health systems should consider routinely offering structured telephone psychotherapy to their patients with diabetes and depression,” concluded senior study author Marcia Valenstein.

(The research was funded by grants from the National Institutes of Health, Michigan Diabetes Research and Training Center and the Michigan Institute for Clinical and Health Research.)

“Metreleptin Treatment Leads to Long-Term Improvements in Diabetes and Lipid Control in Patients with Lipodystrophy”

RESULTS from a new analysis of an ongoing, long-term research study of the investigational drug metreleptin, an analog of the human hormone leptin, demonstrated robust reductions in HbA1c levels and triglycerides that were sustained for several years of treatment in patients with lipodystrophy.

Lipodystrophy

“Lipodystrophy is a rare, debilitating chronic disease with a large, unmet clinical need. No therapies are indicated specifically for the treatment of the metabolic abnormalities associated with lipodystrophy,” Christian Weyer, MD, senior vice president, research and development, Amylin Pharmaceuticals, said at a late-breaking oral session on April 17 at the 20th Annual Meeting and Clinical Congress of the American Association of Clinical Endocrinologists (AACE) in San Diego.

In the study, which has been ongoing for more than 10 years, researchers at the NIH are examining the effects of metreleptin on several metabolic abnormalities, such as diabetes and hypertriglyceridemia, in patients with rare inherited or acquired forms of lipodystrophy.

[Amylin recently submitted the clinical and nonclinical sections of a rolling Biologics License Application (BLA) for metreleptin to treat diabetes and/or hypertriglyceridemia (high levels of triglycerides in the bloodstream) in patients with rare inherited or acquired forms of lipodystrophy. If approved, metreleptin would be the first therapy indicated specifically for the treatment of diabetes and high triglycerides in patients with lipodystrophy, and the first approved therapeutic use of leptin.]

Weyer presented results of an analysis of 55 patients with lipodystrophy who were assigned to metreleptin. According to the researchers, this is the largest cohort to date. At baseline, 75% of patients had uncontrolled diabetes (HbA1c ≥7%) and 75% had hypertriglyceridemia (≥200 mg/dl).

“When metreleptin was introduced as a subcutaneous injection once or twice a day, both HbA1c and triglycerides fell very rapidly and profoundly in the first 4 months of therapy,” Weyer said. When patients were followed to 3 years, the changes were maintained. In the patients with diabetes, mean HbA1c decreased from 9.4% at baseline to lower than 7% at year 3. In the patients with hypertriglyceridemia, mean triglyceride concentrations decreased from 500 mg/dl to under 200 mg/dl at year 3.

Weyer said adverse events were consistent with known comorbid conditions of lipodystrophy, including pancreatitis, proteinuria and autoimmune/chronic hepatitis, or expected pharmacological effects of metreleptin, such as weight loss or insulin-induced hypoglycemia in the setting of improved insulin sensitivity in patients taking high doses of insulin.

Other studies conducted worldwide have demonstrated metreleptin’s positive effects on insulin sensitivity, high triglycerides, hyperglycemia and liver fat in patients with lipodystrophy who are not responsive to conventional lipid and glucose-lowering agents, the researchers said. Amylin is working with the FDA to get approval of metreleptin. If approved, it would be the first therapy indicated specifically for the treatment of diabetes and hypertriglyceridemia in patients with lipodystrophy.

Commenting on Weyer’s remarks, AACE President Elect Yehuda Handelsman, MD, said:

This whole thing about leptin is fascinating, and I think there is so much more to learn about it. (News about) leptin is everywhere: it is related to bone, it turns out, it is related to smell, taste and hunger. We found out from Dr. Unger (here at the meeting) that it suppresses glucagon terrifically.

Dr. Weyer represents an organization that has a drug called exenatide (Byetta), a glucagon-like peptide 1 that we also think in some way suppresses glucagon. It will be interesting to know if there is any relationship between the leptin suppression and glucagon suppression. We can see now that leptin, in the rarest disease, may be more applicable to a larger group of people that may have partial lipodystrophy, and we don’t as yet know how to recognize it.

Diabetes: “Welchol Added to Existing Diabetes Therapy Achieves Better Glucose Control”

WHEN used in combination with certain antidiabetes medications, colesevelam effectively lowers HbA1c levels in adults with type 2 diabetes, reports Endocrine Today.

Colesevelam was approved by the FDA in 2008 for use in combination with metformin (Glucophage), sulfonylureas (Amaryl, DiaBeta, Glucontrol)) and insulin to improve glycemic control in adults with type 2 diabetes.

Harold Bays, MD

Although originally developed as an agent to lower LDL, data from three clinical trials demonstrated that colesevelam (Welchol, Daiichi Sankyo) improved glucose levels in adults with type 2 diabetes, Harold Bays, MD, medical director and president of the Louisville Metabolic and Atherosclerosis Research Center in Kentucky, said during a session of the American Association of Clinical Endocrinologists 20th Annual Meeting in San Diego this week.

Compared with placebo, when added to metformin, insulin and sulfonylureas, colesevelam led to 0.5%, 0.6% and 0.8% reductions in HbA1c levels, respectively, he said. “We did one set of clinical trials with metformin-based therapy, insulin and sulfonylureas…What’s really interesting when we look at the data is that, while these are somewhat different agents, reductions in HbA1c were remarkably similar,” Bays told the audience.

To further evaluate the efficacy of colesevelam, researchers conducted a pooled post-hoc analysis of the three pivotal studies of the drug in patients with type 2 diabetes. In total, the number of patients in the treatment group increased to 355. Results indicated that when added to metformin-based therapy, colesevelam significantly reduced cholesterol levels, improved glycemic parameters and exhibited a good safety profile.

“We found almost exactly what could be anticipated from the original trials,” Bays said. “Data showed reductions in HbA1c, fasting glucose levels, LDL, non-HDL and a nonsignificant increase in HDL and moderate increases in triglycerides.”

Colesevelam was also generally well-tolerated, Bays said. A moderate increase in constipation was the most notable side effect, with 10% to 13% of patients experiencing constipation vs. 2% to 3% in the placebo group. Other common adverse events included nausea, dyspepsia and nasopharyngitis (common cold). In studies involving pediatric populations with heterozygous familial hypercholesterolemia, adverse reactions included nasopharyngitis, headache, fatigue, increases in creatine phosphokinase, rhinitis and vomiting.

Prescribing information for colesevelam recommends against use in patients with a history of bowel obstruction, triglyceride levels greater than 500 mL or with a history of hypertriglyceridemia-induced pancreatitis. Bay emphasized that strict adherence to these indications is important for preventing adverse events and use of clinical judgment.

“We cannot look to these clinical trials for blanket safety information for all patients,” Bays said. “The results are only applicable to those patients who were administered the drug in keeping with the study populations.”

Individualized Care Plans Necessary for Treating Diabetes, Says AACE

The American Association of Clinical Endocrinology (AACE) on April 14 released new clinical practice guidelines for developing comprehensive care plans for patients with type 1 and type 2 diabetes mellitus, developed by a panel of 23 of the leading diabetes experts in the U.S.

Debunking one-size-fits-all care plans, the guidelines emphasize the importance of achieving a treatment plan that avoids hypoglycemia, now considered to be a continual and pressing concern for many patients with diabetes.

The implications of the new guidelines for practicing physicians, as well as new data on low blood sugar in patients with diabetes, are being discussed at the AACE 20th Annual Meeting and Clinical Congress, now in session in San Diego.

Caring Doctors Improve Patients’ A1c, LDL Scores

The new AACE guidelines are also published in supplement 2 of the March/April issue of the association’s official medical journal, Endocrine Practice.

“This guidance is for individual clinicians, for insurers, for government policy and for patients so these guidelines reverberate among the 150 million people who are involved in the world of diabetes,” Daniel Einhorn, MD, 2010-2011 president of AACE, said during a press conference.

“The team of writers understood the need to be truly comprehensive in every aspect. Every single thing about the person with diabetes matters to the outcomes,” Einhorn said. “This is the first year that the guidelines are so comprehensive, and they will continue to grow and be expanded from here.”

The guidelines emphasize a personalized approach to controlling diabetes and achieving blood glucose targets with care plans that take into account patients’ risk factors for complications, comorbid conditions, and psychological, social, and economic status. Although the guidelines recommend a blood glucose target of an HbA1c level of 6.5%, if it can be achieved safely, a treatment plan should take into account a patient’s risk for the development of severe hypoglycemia.

CGM is the New Standard

“This comprehensive approach is based on the evidence that although glycemic control parameters (HbA1c, postprandial glucose excursions, fasting plasma glucose, glycemic variability) have an impact on cardiovascular disease risk, mortality, and quality of life, other factors also affect clinical outcomes in persons with diabetes,” the committee wrote.

One updated recommendation addresses the diagnostic criteria for gestational diabetes. Previously, pregnant women were administered a 50-g, 1-hr oral glucose tolerance test. Now, the guidelines recommend physicians use a 75-g, 2-hour OGTT to diagnose gestational diabetes.

The guidelines also now endorse a target HbA1c level lower than 6.5%, as most nonpregnant healthy adults can safely reach this goal. Physicians should, however, consider each patient’s unique situation. Aggressive treatment, for instance, would be more appropriate in a young, healthy patient than in an elderly patient or a patient with a terminal illness, Handelsman noted.

The new guidelines also provide information on the appropriate use of new technologies such as insulin pumps and continuous glucose monitoring, as well as managing conditions that may not be immediately obvious to treating physicians, such as sleep and breathing disturbances and depression.

Millions Risk Early Death Because of Poor Diagnosis and Ineffective Treatment

In a statement, Yehuda Handelsman, MD, AACE president-elect and co-chair of the AACE Diabetes Guidelines Writing Committee, said that it was crucial for physicians to address not just hyperglycemia in patients with diabetes but also associated cardiovascular risk factors. “These state-of-the-art guidelines provide the most up-to-date evidence-based answers to real-life (clinical) questions,” Dr. Handelsman said.

Tight Cholesterol, BP Control Does Little Good for Diabetics

In the guidelines, AACE recommends comprehensive diabetes lifestyle management education at the time of diagnosis, as well as throughout the course of diabetes. The importance of medical nutrition therapy, physical activity, avoidance of tobacco products, and adequate quantity and quality of sleep should be discussed with patients who have prediabetes, as well as type 1 and type 2 diabetes, according to the new guidelines.

Carefully monitoring patients with prediabetes by regularly assessing their fasting plasma glucose levels or administering OGTTs is recommended, according to Handelsman. In addition, treating obesity is essential.

“We believe that addressing, treating and managing obesity is key to preventing and controlling diabetes and comorbidities,” Handelsman said. Therefore, the guidelines discuss lifestyle modifications, nutritional management, physical activity as well as the potential benefits of surgical options, such as gastric bypass, in appropriate patient populations.

Handelsman stressed the importance of not simply aiming to control diabetes. Lipid profiles, blood pressure and cardiovascular disease risk should be taken into account, and physicians should consider all of these aspects when generating a comprehensive diabetes care plan.

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Even Telephonic Intervention Improves Diabetes Control

Intensive Diabetes Education Programs Improve Blood-Sugar Control

DIABETICS need information in order to manage their disease; but their knowledge about the facts is still not enough for behavioral change. What is needed is to find a way to be able to give people the skills to solve their problems in all areas of their lives so that they can be able to start caring for themselves.

One of the most important aspects of diabetes management is educating the patient to manage their condition themselves. This is known as Diabetes Self-Management Education, better known by its acronym DSME. It has been demonstrated by many studies that education works.

A team of researchers at Johns Hopkins University School of Medicine have developed a diabetes education program that significantly improves long-term blood-sugar control among patients by educating low income, poorly educated diabetes patients to be able to manage their disease. Their findings have been published online in the March issue Journal of General Internal Medicine.

The researcher’s premise was that lower socioeconomic status is associated with excess disease burden from diabetes and that diabetes self-management support interventions are needed that are effective in engaging lower income patients, addressing competing life priorities and barriers to self-care, and facilitating behavior change.

Dividing about 56 participants into two groups, the researchers provided an intensive problem solving course in the first group that lasted more than nine sessions and covered standard diabetes self-management and care. They also include the way in managing financial, social, resource and interpersonal issues that relate to the disease.

The second group received only a solid two-session version of the program.

At the end of the program after three months, those who were in the intensive group showed a fall in hemoglobin levels by an average of 0.7 as compared to the levels they had before the program started. Below 5.7 is considered normal while the target of people with diabetes is below 7. The participants in the two-session group did not see any improvement.

The researchers conclude that literacy-adapted, intensive, problem-solving-based diabetes self-management training is effective for key clinical and behavioral outcomes in lower income patients.

“We know that people need information to manage their disease, but having knowledge of the facts is not enough for behavioral change,” said Felicia Hill-Briggs, an associate professor in the general internal medicine division at the Johns Hopkins University School of Medicine and the study’s lead author.

“With this novel approach, we have found a way to give people the skills to solve problems in all areas of their lives so that they can take diabetes off the back burner and start caring for their health.”

Another DSME advocate Linda Siminerio, RN, PhD, CDE, director of the University of Pittsburgh Diabetes Institute, and associate professor at the University of Pittsburgh School of Medicine and the School of Nursing points out, “Diabetes self-management education (DSME) should always be considered as part of the treatment plan, even if a patient is reported to have excellent metabolic control.

“Attention to self-care behaviors and psychosocial needs are equally as important as metabolic outcomes when managing a burdensome, chronic disease like diabetes. Active listening, providing accurate information and building a patient’s confidence are all important tools used in diabetes education.

“It is (therefore) essential that physicians and everyone on the diabetes care team work together to support patient self-management by developing patient-centered goals that will be more likely to be achieved.”

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