Monthly Archives: April 2011

Diabetics Who Adhere to Their Medication Have a 31% Associated Lower Risk of Hospitalization

Lifestyle-related diseases stemming from tobacco, alcohol and obesity, have taken over infectious diseases such as HIV and malaria to become the greatest killer of people worldwide, says a new World Health Organization report.  Indeed, chronic illnesses like cancer, heart disease and diabetes have reached global epidemic proportions and now cause more deaths than all other diseases combined.

Evidence shows that a comprehensive focus on prevention and improved treatment leads to dramatic declines in mortality rates. Currently, the report points out, the main focus of health care for non-communicable diseases (NCDs) in many low- and middle-income countries is hospital-centered acute care. This is a very expensive approach that will not contribute to a significant reduction of the NCD burden. It also denies people the health benefits of taking care of their conditions at an early stage.

To contain the diabetes worldwide epidemic, WHO says at least three interventions for prevention and management of diabetes are shown to reduce costs while improving health. Blood pressure and glycemic control, and foot care are feasible and cost-effective interventions for people with diabetes, including in low- and middle-income countries.

WHO’s recommendations have been validated by a new study in the U.S. which shows that individuals with diabetes who adhere to their medication have lower risk of hospitalization by one-third when compared to patients who do not adhere to their medication.

The results of the study by Prime Therapeutics (Prime), a thought leader in pharmacy benefit management, are being presented the last week in April at the Academy of Managed Care Pharmacy’s 23rd Annual Meeting and Showcase in Minneapolis earlier this week.

Nearly 300 million people worldwide have (mostly type 2) diabetes. In the U.S. alone, more than 23 million Americans have been diagnosed with diabetes mellitus (DM) and each year another 1.6 million people are diagnosed with the condition.

Poor medication adherence has been associated with worse medical outcomes and increased medical costs for patients with diabetes in a single employer or the elderly.

Until now, there has been little data quantifying the potential value of improved outcomes and costs possible with better medication adherence in a large commercially insured population. In this study, one of the largest of its kind, more than 15,000 commercially insured individuals with a diabetes diagnosis medical claim were followed for one year.

“Our research found adherent individuals had $1,010 lower medical costs during the year,” said Patrick Gleason, PharmD, director of Clinical Outcomes Assessment at Prime, in a press release. “Besides the medical cost savings, patients that adhere to their medications are likely to have improved health and increased quality of life. Yet in this study, we found one-quarter of patients do not stick to their diabetes medication, so the medical community must find ways to increase adherence for those most at-risk.”

Researchers from Prime and one of its Blue Cross and Blue Shield clients reviewed pharmacy and medical claims from a commercial medical plan with 1.3 million members. The study identified individuals continuously enrolled between 2007 and 2009.

Researchers then focused on members who had either two separate office visits for diabetes or a diabetes-related hospitalization in 2008 and with a DM medication supply or a diagnosis of diabetes with microvascular disease. All medical and pharmacy claim costs were added up to determine the total cost of care.

A total of 15,043 members were followed for one year. Of that group, 73.9 percent (11,108 members) were adherent to their medication and 26.1 percent (3,935 members) were non-adherent. While those individuals adherent to DM medication had higher pharmacy costs which led to an increase in the overall total cost of care ($572), those adhering to medications were found to have a 31 percent lower risk of hospitalization and significantly lower overall medical costs ($1,010) than the non-adherent group.

Earlier studies, too, have shown that non-adherence with medication regimens results in increased use of medical resources, such as physician visits, laboratory tests, unnecessary additional treatments, emergency department visits, and hospital or nursing home admissions. Non-adherence may also result in treatment failure.

In the context of disease, medication non-adherence can be termed an “epidemic.” More than 10% of older adult hospital admissions may be due to non-adherence with medication regimens. In one study, one-third of older persons admitted to the hospital had a history of non-adherence. Nearly one-fourth of nursing home admissions may be due to older persons’ inability to self-administer medications.

Problems with medication adherence were cited as a contributing factor in more than 20% of cases of preventable adverse drug events among older persons in the ambulatory setting. It is estimated that non-adherence costs the US health care system $100 billion per year. In addition, approximately 125,000 deaths occur annually in the U.S. due to non-adherence with cardiovascular medications.

Of all age groups, older persons with chronic diseases and conditions benefit the most from taking medications, and risk the most from failing to take them properly. Among older adults the consequences of medication non-adherence may be more serious, less easily detected, and less easily resolved than in younger age groups.

Improving adherence with medication regimens can make a difference. A recently published study found that for a number of chronic medical conditions – diabetes, hypertension, hypercholesterolemia, and congestive heart failure – higher rates of medication adherence were associated with lower rates of hospitalization (see diagram), and a reduction in total medical costs.

How To Manage Diabetes On A Budget Without Cutting Corners

IF you have diabetes, there is no getting around the fact that taking care of yourself can be expensive.  The cost of medical care, diabetes medications and supplies, and healthy foods add up. And these expenses can be difficult to manage even in the best of times.

Even in less developed economies like India and other countries in Asia and Latin America where the spread of diabetes has assumed epidemic proportions, seeing your doctor and a pharmacist every month makes a dent might seem expensive.

Popular blogger Scott Strumello has calculated that in 2007, medical bills contributed to 62.1% of all bankruptcies in the U.S. Between 2001 and 2007, the proportion of all bankruptcies attributable to medical problems rose by about 50%.

Contrary to popular assumptions, chronic illnesses dominate the top 2 categories, and diabetes ranks second, following only nonstroke neurologic problems (i.e., multiple sclerosis).

According to a study published online in The American Journal of Medicine indicated that the health problems that left patients with the highest out-of-pocket medical expenses weren’t dominated by catastrophic illnesses. The article reports that among common diagnoses, the health problems that left patients with the highest out-of-pocket expenses were ranked as follows:

#1) Neurologic (e.g., multiple sclerosis): $34,167

#2) Diabetes: $26,971

#3) Injuries: 25,096

#4) Stroke: $23,380

#5) Mental illnesses: $23,178

#6) Heart disease: $21,955

Also, it is important to keep in mind that among the other categories, diabetes is a leading contributor to the stroke and heart disease categories. These are some pretty astonishing figures!

Another interesting observation: hospital bills are, not surprisingly, the largest single out-of-pocket expense for 48.0% of patients who file for bankruptcy, but the second-largest category isn’t doctor’s bills, its for prescription drugs for 18.6%. Doctors’ bills isn’t far behind, accounting for 15.1%, and premiums accounting for 4.1%. The remainder cited expenses such as medical equipment and nursing homes.

As a person with type 1 diabetes myself, I must admit that while this disease is anything but cheap, even I was a bit surprised by some of these findings, especially considering that in February 2009, the American Diabetes Association and others were citing studies which showed many Americans with diabetes were skipping certain medical treatments, drugs etc. due to the cost.

In the context of rising costs for managing a chronic disease such as diabetes, a small study from Ohio shows that in the long run regular visits to the doctor saves patients and their families money in the long run when

Columbus-area pharmacist Allen Nichol looked at two groups of diabetic patients on Medicaid at one physician’s office – 40 who kept monthly appointments and took their medications as prescribed and 120 who did not. He worked with Dr. Charles May, a primary-care doctor at Grandview Family Practice, and gathered the data in 2008.

During the monthly appointments, they evaluated patients’ blood pressure, cholesterol and blood-sugar levels. If the numbers were good, the patient would continue with the same medications; if not, Nichol would suggest a medication change. “We’d have a plan, like a coach of a football team planning the first quarter,” Nichol said.

The study found that patients not being managed were hospitalized more than those who regularly saw their doctor and pharmacist. This resulted in a net savings of $5,582 per patient for the year, Nichol said.

Health leaders acknowledge the benefits of having pharmacists work with patients, whether at a doctor’s office or a pharmacy. For example, all Medicare prescription-drug plans are required to pay for meetings between beneficiaries and pharmacists. Private health insurers have found that when patients meet with pharmacists, costly emergency-room visits and hospital admissions can be reduced.

Here are a few tips from NFB to help you ensure that you do not miss out on manage your condition during hard times when many patients find it difficult pay their medical bills.

General Financial Management

Having a budget and sticking to it is important for everyone, even more so during hard times. You should evaluate your personal or family budget at least once a year, or more often if your income or expenses are changing.  Involve the entire family in discussing the budget and brainstorming for ways to save money.

Here are a few questions to consider:

• What is your monthly income?

• What are your monthly expenses for essentials (home, utilities, phone, food, transportation, medicine)?

• When are your bills due? Avoid late fees by paying bills on time.

• Do you have expenses that come once or twice a year (such as taxes and insurance)?

• Where does the money go from your wallet?  Keep a diary of your spending.

• Identify non-essential expenses (entertainment, shopping as “stress management,” eating out).

Paying cash helps you stay within your limits.  Use a credit card only in emergencies.  If you have several cards, cancel most of them, and keep one and two. Pay off your credit card bill each month, so you aren’t paying high interest for carrying charges. If you have credit card debt, call your creditors to discuss options to deal with it, and try to negotiate a lower interest rate. If you feel you cannot do this, or if your debt load is overwhelming, seek consumer credit counseling from your bank or card issuer.

Healthy Eating on a Budget

Many people have the misconception healthy meals are always more expensive.  Actually, healthy eating can save money through using smaller portion sizes and fewer high-calorie, high-priced foods.

Here is a list of tips to help you keep your food prices down:

• Plan a menu each week based on sales in grocery stores near you.

• Check what you already have to keep from buying what you do not need.

• Take a shopping list with you, and buy only what is on that list.

• Avoid going to the store if you are hungry, to make it easier to stick to your list.

• Store brand or generics are often just as good as name brand, and usually less expensive.

• Cook enough to have leftovers. Take the leftovers to work instead of buying lunch, or freeze the leftovers for a busy time.

• Add vegetables to casseroles, stews, or soups.  This is a good way to increase your vegetables and stretch a meal.

If you manage your personal finances well, you’ll never find it difficult to skimp on managing expenses related to your medical condition.

A Cure for Diabetes By Implanting Insulin-Producing Islets in Abdomen

Trials on Primates Have Shown Promising Results

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DOCTORS from Hackensack University Medical Center (HUMC) in New Jersey hope to find a cure for diabetes as they embark on a partnership with one of the world’s leading researchers for the disease.

The hospital will be the first to try a procedure on humans with diabetes that is currently being tested on monkeys in Florida — a collaborative effort with Dr. Camillo Ricordi, a pioneer in the field and the scientific director and chief academy officer of the University of Miami Diabetes Research Institute.

“Dr. Ricordi wants to find a cure for diabetes, and he doesn’t care how many people are involved in the process or share in the credit,” said Dr. Michael Shapiro, Hackensack’s chief of organ transplantation and leader of the diabetes partnership. “This collaboration will do great things for diabetes research.”

“Forty percent of transplant patients have diabetes. And we know the DRI is committed to linking everyone worldwide to find a cure,” he said.

Diabetes occurs when the body cannot produce or properly use insulin, a hormone that helps the body metabolize glucose into energy and control blood sugar levels.

With Type 1 diabetes, earlier called juvenile diabetes and the most serious form of the disease, the body’s immune system destroys the cells from the pancreas that make insulin, called islets. People with Type 2 diabetes make insulin, but their body doesn’t utilize it correctly and production of it typically declines as they age. More than 25 million Americans have diabetes, and about 3 million of those suffer with Type 1.

Typical treatment for diabetic patients includes insulin pumps, injections and oral medications. Transplanting islets from deceased donors is sometimes effective, but it frequently triggers other complications because the islets need to be implanted in the liver. The number of organ donors also falls way short of the number of diabetics who would benefit from a transplant.

New Technique

Dr. Ricordi’s technique includes loading islets — the cells that make insulin and are destroyed by Type 1 diabetes — on a disc and implanting them in the abdomen. In the past, islets have been transplanted in the liver with little success.

Dr Camillo Ricordi

“The challenge is we’re dealing with an autoimmune disease so we have to replace or get cells to regenerate that were destroyed,” Ricordi told dozens of HUMC executives, physicians and health care workers last week. “And the key is to do this without a lifelong regimen of autoimmune rejection drugs.”

But successfully transplanting the islets will only be part one of the cure. Researchers need to figure out how to create islets in the lab so there will be enough to treat all diabetic patients who need them. Still, the partnership has hospital executives determined and diabetic patients hopeful. “I’m absolutely sure we’ll find a cure,” said Robert Garrett, president and chief executive of HUMC.

Because of promising results with the monkeys, Shapiro hopes to have four patients undergo the procedure in early 2012. The ideal patients will be those who aren’t responding to other treatments.

Past Success

Physicians attending the announcement highlighted Ricordi’s expertise and advances in treatment of the disease.

His creation, the Ricordi Chamber, is so well-known in the field that it was mentioned in a recent episode of the medical drama “Grey’s Anatomy.” Critical for a transplant, it is able to efficiently separate islets from the pancreas.

Stephanie Stone, who was diagnosed with diabetes at 10 and is now 18, attended the announcement with her Franklin Lakes family. “I’m optimistic for the future,” Stephanie said. “If this isn’t a cure, it sounds like it’s a better treatment before a cure is found.”

Earlier in January, the Molly and Lindsey Diabetes Research Foundation at Hackensack University Medical Center (HUMC) and the Diabetes Research Institute (DRI) at the University of Miami Miller School of Medicine had announced the formation of the Hackensack-Miami DRI Federation Project.

The project is aimed to provide a unique opportunity for funding agencies, financial institutions, and corporate entities to collaborate with the scientists and their project teams in order to provide the core competencies and infrastructure needed to move projects forward in the safest, fastest, and most efficient way possible.

“This collaboration represents an exceptional opportunity to overcome current limitations of research progress within traditional academic institutions,” said Robert C. Garrett,

“Hackensack University Medical Center is going to take the lead in diabetes research in the tri-state area,” said Dr. Shapiro. “Forty percent of transplant patients have diabetes. And we know the DRI is committed to linking everyone worldwide to find a cure.”

One of the group’s first objectives is to expand collaborative alliances with other leading research centers and to foster dynamic multidisciplinary research teams.

“There are few other collaborative projects that fully integrate basic, pre-clinical and clinical scientists to increase the rate of progress at which therapeutic solutions for type 1 diabetes can be safely and effectively brought from the bench to the bedside and eventually to a cure,” said Dr. Ricordi.

The impossible becomes possible when you bring the right people and the right resources together – especially when there is a common goal. The Molly and Lindsey Diabetes Research Foundation is the brainchild of two families who know what it means to have a child living with diabetes.

Nick Miniccuci and his wife, Susan, made a pledge more than two decades ago when they were told their nine-year-old daughter Molly had diabetes. “I vowed to do everything in my power to find a cure” explains Mr. Miniccuci, one of the philanthropists behind the alliance.  “That was a promise I intend to keep.”

“When Lindsey was diagnosed at the age of 11, we searched the world for a place that focused on curing the disease – not simply on learning to live with it –  and found theDRI,” said Bonnie Inserra, co-founder of the Foundation.  “There’s nobody like them worldwide. TheDRI team doesn’t keep research to themselves; they are experts who believe in worldwide collaborative science.  I want to see diabetes cured.”

In recognition of the endless efforts of Susan and Nick Minicucci and Bonnie and Larry Inserra, the HUMC Foundation’s Executive Vice President and Chief Operating Officer Robert L. Torre, presented a $500,000 check to the Miami-Hackensack project during a dinner held in January at the Stony Hill Inn Hackensack.  More than 50 people came together to celebrate a turning point in the history of diabetes thanks to the Minicucci and Inserra families. “We want to celebrate this new partnership – together we will find a cure,” Torre said.

About HUMC

HUMC is a nationally recognized healthcare organization offering patients the most comprehensive services, state-of-the-art technologies, and facilities. A leader in providing the highest quality patient-centered care, the medical center has been recognized for performance excellence encompassing the entire spectrum of hospital quality and service initiatives. These honors include being named one of America’s 50 Best Hospitals by HealthGrades® for four years in a row.

HUMC is the only hospital in New Jersey, New York, and New England to receive this honor. The medical center has also been ranked by U.S. News and World Report’s “America’s Best Hospitals 2010-11” in Geriatrics and Heart and Heart Surgery. NJBIZ, New Jersey’s premiere business news publication, honored HUMC as the 2010 Hospital of the Year, recognized for its excellence, innovation, and efforts which are making a significant impact on the quality of healthcare in New Jersey.

Hospital Newspaper, the leading provider of local hospitals and healthcare community news and information for hospital executives, also named HUMC Hospital of the Year in its December 2010 edition. Additionally, HUMC was named to The Leapfrog Group’s annual class of top hospitals and health systems and is one of only two hospitals in New Jersey to receive this national designation. HUMC is the hometown hospital of the New York Giants and Nets Basketball.

About the DRI

The Diabetes Research Institute, a Center of Excellence at the University of Miami Miller School of Medicine, is a recognized world leader in cure-focused research. Since its inception in the early 1970s, the DRI has made significant contributions to the field of diabetes research, pioneering many of the techniques used in islet transplantation.

The DRI is now building upon these achievements by bridging cell-based therapies with emerging technologies to restore insulin production. For the millions of families already affected by diabetes, the Diabetes Research Institute is the best hope for a cure.  Visit DiabetesResearch.org or call 800-321-3437 for more information.

Benchmark Cambridge Trial In Quest For Ambulatory Artificial Pancreas

I had reported earlier that once perfected and approved by regulators, safe and robust ambulatory artificial pancreas ‒ or to use the scientific term ‘closed loop insulin delivery system’ ‒ has the potential to greatly improve the health and lives of people with type 1 diabetes. The idea itself is not new but the old generation closed loop insulin delivery systems were cumbersome and unsuitable for long term or outpatient use.

Artificial pancreas concept

The newer systems link a continuous glucose monitor and a subcutaneous insulin infusion pump via a control algorithm, which retrieves continuous glucose monitoring data in real time (for example, every five minutes) and uses a mathematical formula to compute insulin delivery rates that are then transmitted to the insulin pump.

However, artificial pancreas that can be worn by diabetics on their person as they go about their daily lives is still in development, with the first in-clinic studies now being reported. Preliminary results have been promising ‒ the most notable improvement is in overnight control of type 1 diabetes, with improvements in safety and a reduction in nocturnal hypoglycemia being reported.

These improvements result from the fine adjustment of insulin delivery provided by closed loop control overnight being superior to a generally fixed basal rate and less likely to cause hypoglycemia. The first application of closed loop control is therefore likely to be in glucose regulation overnight, a step that has the potential to improve dramatically the safety of insulin delivery during crucial, generally unsupervised, periods.

Now a University of Cambridge research tem led by Roman Hovorka has demonstrated the safety and efficacy of overnight closed loop insulin delivery with conventional insulin pump therapy in adults with type 1 diabetes.

Artificial Pancreas Best Hope For Diabetics In Near Term

The trial group consisted of 24 adults (10 men and 14 women) aged 18-65, who had used insulin pump therapy for at least three months and the research team used two protocols ‒ a medium sized meal (60 g carbohydrate) and a large size meal (100 g carbohydrate + alcohol) ‒ to see whether artificial pancreas were effective in overcoming nocturnal hypoglycemia.

As in previous studies carried out by Boris Kovatchev and others in the U.S. and France, the Cambridge closed loop system significantly increased the time that plasma glucose was in the target range (70-144 mg/dl), reduced incidence of hypoglycemia, and better overnight control.

But what makes the Cambridge study important is that the randomized crossover trial design is virtually unique in the field of closed loop control. Because this design is the gold standard for clinical research, the results set a benchmark for future studies.

The only other randomized controlled trial of closed loop control was recently presented by the University of Virginia research team led by Kovatchev at the 4th International Conference on Advanced Technologies and Treatments for Diabetes. This study recruited 24 adults and adolescents with type 1 diabetes in the United States and in France and achieved results similar to those reported by Hovorka and colleagues ‒ more time within the target range of 70-180 mg/dl and a threefold reduction in hypoglycemia.

Dr Roman Hovorka

Moreover, the control algorithm used by Hovorka and colleagues belongs to an advanced class of closed loop control technologies known as “model predictive control”. Algorithm designs for artificial pancreas have generally used either “proportional-integral-derivative control” or “model predictive control”.

Proportional-integral-derivative control algorithms are reactive, responding to changes in glucose levels with adjustment in insulin delivery. Model predictive control algorithms are built over a model of the human metabolic system and are therefore proactive, delivering insulin in anticipation of changes in glucose concentrations.

This compensates partially for the time delays inherent in subcutaneous glucose control (the time delay in insulin action, which can amount to 60 minutes or more). For this reason, model predictive control has become the approach of choice more recently.

The algorithm developed by Hovorka and colleagues has certain distinct features, such as real time adaptation of the underlying model to changing patient parameters implemented as a selection from several predefined models. However, this potential advantage remains to be evaluated.

Most importantly, this is one of the first studies to test realistic meal scenarios and challenge the participants with a large dinner that included alcohol. As such, the study is a clear advance in the quest for an artificial pancreas that can be used by a diabetic while performing normal daily activity.

However, as the authors admit, one limitation is the exclusively manual control of the artificial pancreas used relied on study personnel to transmit data manually from the continuous glucose monitor (CGM) to the computer running the closed loop control, and to transmit insulin injection recommendations from the computer to the insulin pump because of technological and regulatory barriers

In fully automated systems ‒ which is what researchers and medical device makers are hoping to make a reality for diabetics ‒ these processes are handled by data transmission and pump control devices, respectively. However, Cambridge method limited the investigation to testing only the control algorithm, not the artificial pancreas as a whole. The testing of other key components, such as sensor-pump communication and error mitigation, would require much more effort and thorough system validation.

Studies using fully automated systems have already been reported by the Artificial Pancreas Project and offer hope for the future of ambulatory systems i.e. devices that be worn by diabetics on their person in their daily lives.

Lastly, despite the sophistication of the control algorithm and the significant reduction in nocturnal hypoglycemia, four episodes of severe hypoglycemia (<70 mg/dl) occurred, three of which the authors thought were attributable to the preceding prandial insulin dose and could not be prevented by the artificial pancreas suspending insulin delivery.

This finding reinforces the recently proposed idea that a dedicated hypoglycemia safety system ‒ a separate algorithm responsible solely for the assessment and mitigation of the risk of hypoglycemia ‒ may need to accompany closed loop control. Such safety systems already exist, and have proved useful.

Based on ‘Boris Kovatchev: Closed Loop Control For Type 1 Diabetes (BMJ 2011; 342:d1911)

Related Post: 

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.)

TeloVac Vaccine Trial Holds Hope For Diabetics With Pancreatic Cancer

More than 1,000 patients with advanced pancreatic cancer have joined the final stage trial at 53 hospitals in Britain

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LIVING with diabetes means being diligent about listening to your body for any signs or symptoms that something isn’t quite right. Most people with diabetes know to watch out for issues with their circulation, kidneys, and even gums; but how many realize they should be on the alert for cancer, specifically pancreatic cancer?

Pancreatic cancer is the eighth major form of cancer-related death worldwide, causing 227 000 deaths annually. And Type 2 diabetes is widely considered to be associated with pancreatic cancer. But whether this represents a causal or consequential association is unclear.

Researchers have found that about 80 percent of people who have pancreatic cancer also have glucose intolerance (blood sugar levels that are high, but not yet at diabetic levels) or diabetes.

Another study found that people diagnosed with diabetes after age 50 are eight times more likely to develop pancreatic cancer compared with the general population.

Indeed, pancreatic cancer has the worst survival rate of all common cancers ‒ just three in 100 patients survive the disease for five years or more.

It is for this reason that the Phase-3 (final stage) trial in the UK on the GV1001 vaccine (TeloVac) to treat pancreatic cancer is being followed with great interest around the world. The vaccine is being developed by GemVax AS, a subsidiary of Pharmexa A/S.

Vaccines are usually associated with preventing infections, but this is part of a new approach to try to stimulate the immune system to fight cancer. The trial involves regular doses of the GV1001 vaccine (TeloVac) together with chemotherapy and compares this with chemotherapy alone.

One of the best documented therapeutic cancer vaccines currently in development, GV1001 is a 16-amino acid peptide vaccine that comprises T cell epitopes from human telomerase, an enzyme which is over-produced by cancer cells.

The vaccine ensures robust activation of both CD4+ (memory) as well as CD8+ (cytotoxic) T-cells. The aim is to stimulate the immune system to recognize the telomerase which sits on the surface of the cancer cells and to target the tumor.

Professor John Neoptolemos from Royal Liverpool University Hospital, who is helping to co-ordinate the trial, said: “The problem is tumors are clever and are able to turn the immune cells into traitors which help to guard the tumor. The vaccine takes away the masking effect of the tumor.”

Cancer Research UK’s chief clinician Professor Peter Johnson said: “One of big problems with cancer treatment is you are almost always left with a few malignant cells and it is from those few cells that the cancer can regrow. If you can program the immune system to recognize those cells and get rid of them altogether or keep them in check then you can effectively stop the cancer from growing back lifelong.”

Doctors usually treat advanced pancreatic cancer with gemcitabine (Gemzar) and capecitabine (Xeloda) chemotherapy. But there is evidence suggesting that using a type of treatment called immunotherapy as well as chemotherapy may give better results. Immunotherapy is a type of biological therapy.

The TeloVac trial is to see whether giving the GV1001 vaccine as well as chemotherapy will improve treatment for pancreatic cancer.

Immune system cells search for and kill abnormal cells. But they don’t always recognize cancer cells as being abnormal. The GV1001 vaccine works by teaching immune cells to recognize certain proteins (antigens) made by pancreatic cancer cells. The immune cells can then find the pancreatic cancer cells and kill them.

Doctors want to find out how well the GV1001 vaccine works when it is used with chemotherapy as well. The aims of this trial are to see:

• If adding GV1001 to gemcitabine with capecitabine chemotherapy helps pancreatic cancer treatment to be more successful

• What the side effects are when GV1001 is added to gemcitabine with capecitabine chemotherapy treatment

• How well GV1001 helps the body’s immune system to attack pancreatic cancer cells

The Phase-3 TeloVac trial should produce results in just over a year which will show whether the vaccine has a positive effect. Cancer Research UK is keen to stress that the vaccine is not a cure, but if it works, might prolong life.

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Pancreatic Cancer Risk and Diabetes: What Can You Do?

If you have diabetes, there are ways to reduce your risk of pancreatic cancer and increase your chances of catching it earlier if it does occur:

• Be aware of pancreatic cancer risk factors. Some risk factors for pancreatic cancer cannot be changed, such as being over age 60, being African-American, being male, and having a family history of pancreatic, colon, or ovarian cancer. Other pancreatic cancer risk factors, however, can be reduced or eliminated, including being overweight and smoking.

• Ask for tests. Going with the hypothesis that pancreatic cancer may cause diabetes, it would be reasonable for people newly diagnosed with diabetes to ask their doctor if there are any tests they should have to rule out pancreatic cancer. Because the non-specific early symptoms of pancreatic cancer — pain, jaundice, and weight loss — can be hard to detect or easily confused with other diseases, pancreatic cancer diagnosis may be difficult and often is not made until the cancer has spread.

• Eat a healthy diet. Once it is determined that pancreatic cancer is not behind the diabetes diagnosis, it is important for people with diabetes to keep their blood sugar levels under control by eating well-balanced meals in the right portion size.

• Stay active. Exercise is another important aspect to work into your daily schedule, especially if you are overweight. Losing the extra pounds can be doubly beneficial by helping keep the diabetes under control and reducing the overall risk for developing pancreatic cancer.

Finally, simply be aware of your body and how you feel. If you experience abdominal pain, sudden weight loss, or any other significant changes, be sure to call your doctor.

Source: CancerHelp UK

Bad Diet for Expectant Mother Can Mean a Fat Baby and Later a Diabetic Adult

AN expectant mother’s diet can create an obesity time bomb for her unborn child by altering the baby’s DNA in the womb, increasing its risk of obesity, heart disease and diabetes in later life, a groundbreaking study has revealed.

The process ‒ called epigenetic change ‒ can lead to her child tending to lay down more fat. Importantly, the study shows that this effect acts independently of how fat or thin the mother is and of child’s weight at birth. The study found there was an element in a woman’s diet, particularly during the first third of a pregnancy that was of crucial importance.

The epigenetic changes ‒ which alter the function of our DNA without changing the actual DNA sequence inherited from the mother and father ‒ can also influence how a person responds to lifestyle factors such as diet or exercise for many years to come. The changes were noticed in the RXRA gene that makes a receptor for vitamin A, which is involved in the way cells process fat.

The study ‒ to be published on April 26 in the journal Diabetes ‒ shows that the epigenetic effect work independently of how fat or thin the mother is – meaning thin mothers who eat badly are just as likely to cause obesity in their children as fat ones.

The scientists drew their conclusions after measuring epigenetic changes in nearly 300 children at birth (samples first taken after birth using umbilical cord tissue DNA), and relating these to obesity rates at six or nine years of age.

What was surprising was the size of the effect: children vary in how fat they are, but measurement of the epigenetic change at birth allowed the researchers to predict 25 per cent of this variation, basically by mapping data to the topology they had and achieving results which would be the placebo effect in a medical study.

Keith Godfrey, Professor of Epidemiology and Human Development at the University of Southampton, who led the international study, said: “It is both a fascinating and potentially important piece of research. All women who become pregnant get advice about diet, but it is not always high up the agenda of health professionals. The research suggests women should follow the advice as it may have a long term influence on the baby’s health after it is born.”

Speaking in Auckland, Peter Gluckman, from Auckland University’s Liggins Institute, who led the New Zealand team, said the rate of epigenetic change was possibly linked to a low carbohydrate diet in the first three months of pregnancy, but it was too early to draw a definitive conclusion and further studies were needed.

He said one theory was that an embryo fed a diet containing few carbohydrates ‒ which provide the body with energy ‒ assumed it would be born into a carbohydrate-poor environment and altered its metabolism to store more fat, which could be used as fuel when food was scarce.

“This study provides the most compelling evidence yet that just focusing on interventions in adult life will not reverse the epidemic of chronic diseases, not only in developed societies but in low socio-economic populations too,” he said.

Fat Fathers Pass on Diabetes

Gluckman added that it is not just women who should be mindful, as it is likely obese fathers change the DNA in the sperm, ultimately influencing how the baby develops its control of blood sugar and fat deposition after that baby grows up.

“There is good evidence in animals, and there is some supportive evidence in humans that fathers who are obese have impact on the gene switches of their babies as well. We should not imagine that father has no role in determining the outcome of the baby’s health.”

It has long been known a mother’s diet can affect her unborn child, but the research reveals how much of an influence it can have on a child’s health. While it is not clear exactly which foods have the greatest influence on the DNA of unborn babies, a link was found with mothers on low carb diets.

Humans originally ate food as it came in nature ‒ legumes, pulses, things like lentils and chick peas, and fruits. Root vegetables and potatoes are a lovely source of carbohydrate as well. It is therefore important mothers are educated about the effects of diets.

Low-carb diets are in fashion and women have used them to control their weight, but where that information has gone awry is people have become confused and cut-out really important sources of carbs like legumes and fruit.

The study will continue for a at least two more years as scientists look into which foods are the most harmful for unborn babies, but in the meantime their advice for expectant mothers is to eat a balanced diet.

Diabetes+Diet Sodas: Confusing Cause and Effect

SCIENTISTS like to remind us not to confuse cause and effect. But they’re not immune from making that mistake themselves. Last week, for example, the mass media reported a Harvard University study that has exonerated diet sodas and other artificially-sweetened beverages from previous studies linking their consumption to diabetes.

“This is such a great example of confusing cause and effect. It’s akin to saying ‘playing basketball makes you tall’ because height and basketball are correlated. Of course, the real answer is that taller people play basketball,” says Dr. Josh Bloom of the American Council on Science and Health.

The new study ‒ published in The American Journal of Clinical Nutrition ‒ indicates that the link is a result of other factors common to both diet soda drinkers and people with diabetes, including that they are more likely to be overweight. In other words, people who are already diabetic or overweight are drinking more diet soda for those very reasons.

The Harvard University researchers, who followed a large group of men for 20 years, found that drinking regular soda and other sugary drinks often meant a person was more likely to get diabetes, but that was not true of artificially-sweetened soft drinks, or coffee or tea.

They found that men who drank the most sugar-sweetened beverages ‒ about one serving a day on average ‒ were 16 percent more likely to be diagnosed with diabetes than men who never drank those beverages. The link was mostly due to soda and other carbonated beverages, and drinking non-carbonated sugar-sweetened fruit drinks such as lemonade was not linked with a higher risk of diabetes.

When nothing else was accounted for, men who drank a lot of diet soda and other diet drinks were also more likely to get diabetes. But once researchers took into account men’s weight, blood pressure, and cholesterol, those drinks were not related to diabetes risk.

Replacing sugary drinks with diet versions seems to be a safe and healthy alternative, the authors say. “There are multiple alternatives to regular soda,” says Dr. Frank Hu, one of the study’s authors, adding, “Diet soda is perhaps not the best alternative, but moderate consumption is not going to have appreciable harmful effects.”

When asked to comment on the study, Dr. Rebecca Brown, an endocrinologist at the National Institutes of Health, who has studied artificial sweeteners but was not involved in the Harvard research, told Reuters Health: “People who are at risk for diabetes or obesity…those may be the people who are more likely to choose artificial sweeteners because they may be more likely to be dieting.”

Hu and his colleagues analyzed data from more than 40,000 men who were followed between 1986 and 2006. During that time, participants regularly filled out questionnaires on their medical status and dietary habits, including how many servings of regular and diet sodas and other drinks they consumed every week. About 7 percent of men reported that they were diagnosed with diabetes at some point during the study.

The study also found that drinking coffee on a daily basis ‒ both regular and decaffeinated ‒ was linked to a lower risk of diabetes. Researchers aren’t sure why that is, but it could be due to antioxidants or vitamins and minerals in coffee, Hu said.

Brown said that while there are still some health concerns about artificial sweeteners, none have been proven. “I certainly think that we have better evidence that drinking sugar-sweetened beverages increases health risks,” Brown said, adding, “Certainly, reducing sugar-sweetened beverage consumption by any means (including substitution with diet drinks) is probably a good thing.”

Breaking News: Type-2 Diabetes May Be An Autoimmune Disease

Type-2 diabetes is characterized by the gradual development of insulin resistance, which affects the ability of the body to properly metabolize glucose. It’s associated with being overweight, but it can also have a genetic component. But despite the fact that millions of people have type-2 diabetes, the root cause of the insulin resistance is not known

Today, Stanford researchers reported that type-2 diabetes is looking more and more like an autoimmune disease, rather than a strictly metabolic disorder.

“The main point of this study is trying to shift the emphasis in thinking of type 2 diabetes as a purely metabolic disease, and instead emphasize the role of the immune system in type 2,” says the study’s co-first author Daniel Winer, MD.

Commenting on the findings, Dr. David Kendall, chief scientific and medical officer for the American Diabetes Association, said, “This doesn’t change our current approach to type 2 diabetes therapy, but it’s important to understand that type 2 has multiple contributors to its onset. For some people, it may be an immune component, and if it is, we should be able to develop some better therapies.”

“People with type 2 diabetes are often blamed for bringing the disease on, but it’s a combination of genetic and physiological factors exposed to a certain environment. And, this study points out what may be another important biologic factor,” he added.

Be that as it may, these findings ‒ published online April 17 in the journal Nature Medicine ‒ will change the way people think about obesity, and will likely impact medicine for years to come as physicians begin to switch their focus to immune-modulating treatments for type-2 diabetes.

Although the causes of type 2 haven’t been clear, it’s known that the disease runs in families, suggesting a genetic component. Also, while type 2 is strongly linked to increased weight, not everyone who is overweight gets type 2 diabetes. And, that’s what got the researchers searching for another factor.

In 2009, Daniel Winer (along with his twin brother Shawn) showed that T- cells of the immune system were involved in people developing insulin resistance. They have now discovered that another immune cell, called a B-cell, also plays an important role.

Winer explained that excess weight has been linked to inflammation, which can cause the immune system to react. As visceral fat (abdominal fat) expands, it eventually runs out of room. At that point, the fat cells may become stressed and inflamed, and eventually the cells die. When that happens, immune system cells known as macrophages come to sweep up the mess.

Other immune system cells, known as T-cells and B-cells, also respond to the stressed or dying cells. But, these cells are the ones that create specific antibodies to remember a threat to the body. For example, these are the cells responsible for creating immunity when you’re exposed to a certain flu virus.

In this case, however, instead of creating antibodies against a foreign substance, immune system cells ‒especially the B cells ‒ create antibodies against fat cells. Those antibodies then start attacking the fat cells, making them insulin resistant and hindering their ability to process fatty acids. In addition to type 2 diabetes, this onslaught against the fat cells is associated with fatty liver disease, high cholesterol and high blood pressure, according to the researchers.

The researchers found that mice genetically engineered to lack B cells were protected from developing insulin resistance even when they grew obese on the high-fat diet (60 percent fat). However, injecting these mice with B cells or purified antibodies from obese, insulin-resistant mice significantly impaired their ability to metabolize glucose and caused their fasting insulin levels to increase.

Interestingly, treating the mice with a compound called anti-CD20, which targets mature B cells for destruction, kept the animals from developing insulin resistance. The human version of anti-CD20, called rituximab, is already FDA-approved to treat some blood cancers and autoimmune disorders.

The researchers also tested blood samples from 32 obese humans. Half had insulin resistance. Those who were insulin-resistant had a distinct set of antibodies compared to the antibodies found in those without insulin resistance. This, according to Winer, suggests the possibility of developing a vaccine for type 2 diabetes based on what appear to be protective antibodies in those who are obese but not insulin-resistant.

Pointing out the mice and the human volunteers were all male, Winer said it’s not clear if these findings are applicable to women. He also noted that anti-CD20 is not benign ‒ it dampens the immune system and can cause significant side effects, it’s not certain if it would ever be used for type 2 diabetes because other treatments are available.

Sources: Stanford News, HealthDay, Nature Medicine

“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.

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