Monthly Archives: June, 2011

Evidence for Statin Link to Diabetes Grows Stronger

written by Michael O’Leary

The good news is intensive treatment with high doses of cholesterol-lowering statin drugs do reduce your chances of chest pain, heart attack or other cardiovascular problems. The bad news is the higher the statin dose the greater your chance of developing diabetes.

That’s the finding of a pooled-data study involving 32,752 nondiabetic people who participated in five clinical trials and were followed for five years. The analysis of previously conducted studies by David Preiss of the University of Glasgow, United Kingdom was published this week in the Journal of the American Medical Association.

During the five years of follow-up 2,749 participants in these trials (8.4 percent) developed diabetes. Of these, 1,449 were taking intensive doses of statins, and 1,300 were taking moderate statin doses. That worked out to about a 12 percent increased risk of developing diabetes for those in the intensive therapy group compared to the moderate group.

Whenever researchers find that the incidence of something rises with an increasing exposure to something else, they are relatively confident that that the exposure is at least a contributory cause of the effect. This is called dose-dependent effect. In this case they are fairly certain that increasing the dose of statins does increase the risk of developing diabetes.

“Our findings suggest that clinicians should be vigilant for the development of diabetes in patients receiving intensive statin therapy,” the authors write. “In conclusion, this meta-analysis extends earlier findings of an increased incidence of diabetes with statin therapy by providing evidence of a dose-dependent association.”

It is significant to note that 6,684 of the 32,752 participants (20.4 percent) experienced a major cardiovascular event. Of those, 3,134 were in the intensive dose group and 3,550 were in the moderate-dose group. In other words, 416 fewer patients in the intensive statin group experienced cardiovascular events compared to the moderate group.

Overall, the study reinforces the need to weigh the risks and benefits of any given treatment regimen.

 

New Videos from National Diabetes Education Program

written by Michael O’Leary

Looking for reliable online help with managing your diabetes?

The National Diabetes Education Program (NDEP) now has a series of three- to five- minute videos of real people with diabetes talking about the things you can do to improve your health, manage your diabetes, and find the support you need to live with diabetes. The videos are the latest additions to the NDEP website including a redesign of NDEP’s online library of resources, Diabetes HealthSense.  The extensive library of publications, resources, research tools and programs is now searchable.

“For more than 14 years, the NDEP has been in the forefront of raising awareness about diabetes,” said Dr. Griffin P. Rodgers, director of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), “but more needs to be done to provide resources and tools to support health care providers and their patients when it comes to achieving and sustaining health goals.”

The videos feature people living with diabetes, and expert professionals with useful steps you can take to prevent or control diabetes.

Diabetes patient Sorcy Apostol talks about changes she made to her family’s eating habits and physical activity to manage her diabetes and to prevent the disease in her daughters.

When Latecia Turner began caring for her mom living with diabetes, she knew she needed to make changes in her own life to prevent the disease.

National Diabetes Education Program Chair Marti Funnell offers tips for finding the support from your family, friends and community to make the changes you need to live with your diabetes.

Donna Rice, diabetes nurse educator, discusses the importance of setting goals to help make changes to prevent or manage diabetes. She emphasizes breaking down goals into small steps that make it easier to achieve each goal.

In addition, the Diabetes HealthSense site lets viewers choose what they’d like help with, such as how to cope with stress and emotions, healthy eating and physical activity. They can also use tracking tools for calories, physical activity, or online programs to help them manage their weight or stop smoking.

NDEP is jointly sponsored by NIH and the Centers for Disease Control and Prevention. NDEP works with more than 200 partners and offers materials and resources to the general public, people diagnosed with diabetes, and health care and business professionals. NDEP resources are available at www.YourDiabetesInfo.org or by calling toll-free 1-888-693-NDEP (1-888-693-6337).

 

Second Stroke More Likely in Patients with Diabetes

written by Michael O’Leary

If you have type 2 diabetes, you are probably aware that you are at greater risk for a stroke. A new analysis of data from a previous study shows that if you’ve already had a stroke, or mini-stroke, you have a 62 percent higher risk of a second one compared to similar patients who do not have diabetes.

The study led by Dr. Alfred Callahan, of Vanderbilt University and published in the June issue of Archives of Neurology, used data from the Stroke Prevention by Aggressive Reduction of Cholesterol Levels (SPARCL) trial.

That trial was designed to evaluate the value of aggressive cholesterol lowering for reducing strokes in patients who have had so-called mini-strokes, or transient ischemia attacks (TIA).

For this study the researchers re-analyzed the outcomes of 4,731 participants in the SPARCL trial who had experienced either a hemorrhagic stroke, or TIA. A total of 794 individuals were classified as having type 2 diabetes, 642 had metabolic syndrome, which is a combination of being overweight, and having high lipid and glucose levels in the blood. The remaining 3,295 study participants had neither condition.

They looked for recurrence of stroke, major coronary or cardiovascular events or any coronary heart disease events including bypass surgery or angioplasty.

They found that 144 people (18 percent) of those with type 2 diabetes had second strokes. That compared to 69 patients (10.7 percent) with metabolic syndrome and 363 patients (11.0 percent) of those with neither condition.

A total of 49 patients (6.2 percent) with diabetes had a subsequent major cardiovascular event after a stroke or TIA compared to 28 patients (4.4 percent) with metabolic syndrome and 124 patients (3.8 percent) with neither condition.

Patients in the SPARCL trial who were given the aggressive statin medication treatment to lower their cholesterol did experience a lower rate of subsequent cardiovascular events compared to those who did not take statins. That protective effect against a second stroke or cardiovascular event remained the same in this study. Those with or without diabetes or metabolic syndrome did have a lower risk of a second stroke if they were in the statin group.

 

Scott K. Johnson (scottsdiabetes.com) and His Excellent Clinical Trial Adventure

Scott K. Johnson has been actively involved with the Diabetes Online Community (DOC) for almost six years.   He blogs at www.scottsdiabetes.com, tweets at @scottkjohnson, is also a co-host for DSMA Live, does outreach for the Diabetes Research Institute Foundation, and has been an active writer for dLife and Diabetes Care Club.  Along with all of that, Scott has also participated in two different clinical trials for type 1 diabetes.  I recently spent about an hour on the phone with Scott to find out more about the experience.

Scott lives near Minneapolis and both trials took place at the nearby University of Minnesota Hospital.  He signed up for the first study about ten years ago.  Called the RASS Study, this was a five-year trial investigating whether or not a low dose blood pressure medication could help reduce long-term kidney damage.

All of the participants had to have type 1 diabetes.  Also, it was a double-blind study, which meant that neither Scott – nor the researchers – knew whether or not he was receiving the medication or a placebo.

Scott said he wasn’t too worried about the risks because the study was looking at commonly used blood pressure medications and at low dose.   It was easy to participate – from his perspective, “It was just another pill.”

Scott was interested in helping diabetes research – but was particularly motivated because of extensive examination he received.  He had a kidney biopsy at both the beginning and ending of the trial and also had periodic detailed eye photographs taken– all for free.

In the end, the researchers determined that the medication didn’t do much to help the kidneys – although it might have some positive benefit for eye health.  Also, at the end of the five years, Scott found out he had been receiving the medication, not the placebo.  All told, Scott was very positive about the experience – particularly because of the detailed attention paid to his diabetes.

Not long after this trial, the researchers invited Scott to participate in another clinical research study.  Scott described it as “kind of a fun study”.  Instead of investigating a medication, they were studying the impact of a weekly visit with a dietician and intense coaching on diet and exercise.  In Scott’s case, the impact was great – he lost 30 pounds!

Overall, Scott was enthusiastic about participating in clinical trials.  In particular, he raved about the University of Minnesota Hospital system.  Participating in research was a rewarding experience and the researchers there treated him with appreciation and respect.

 

Interested in finding trials for type 1?  Visit: https://trials.jdrf.org

Interested in type 2?  Use the search engine at: http://www.corengi.com

 

Jimmy Jet, the TV Set, and Diabetes Risk

written by Michael O’Leary

Jimmy Jet and His TV Set – Poem by Shel Silverstein

The more TV you watch the greater your chance of type 2 diabetes.  That’s what a new study in Journal of the American Medical Association says.

The study is what is called a meta-analysis. The two researchers, Dr. Frank Hu and doctoral student Anders GrØtved at the Harvard School of Public Health, pooled data from all published studies from 1970 to 2011 that included information about TV viewing and diabetes, cardiovascular disease and premature death.

There were a total of eight studies during that time that included TV viewing as a risk factor for these health conditions, and four of those reported results on type 2 diabetes.

Overall, the analysis involved a total of 175,938 individuals, which included 6,428 cases of type 2 diabetes over a total of 1.1 million person-years of follow-up. The results showed a dose-response relationship between TV viewing and disease, meaning the more TV watched, the greater the risk of type 2 diabetes, cardiovascular disease, and premature death.

The results showed that more than two hours of TV viewing per day increased risk of type 2 diabetes and cardiovascular disease, and more than three hours of daily viewing increased risk of premature death. Each additional two hours of daily TV viewing increased the risk of type 2 diabetes by 20 percent, increased the risk of cardiovascular disease by 15 percent and increased the risk of premature death by 13 percent.

Put in absolute terms, the researchers estimated that for every 100,000 individuals, each two-hour increment in TV viewing per day was associated with 176 new cases of type 2 diabetes, 38 new cases of fatal cardiovascular disease, and 104 premature deaths from all causes per year.

A key limitation of the study according to the researchers is that they could not exclude confounding risk factors.

“Although the included studies attempted to control for various known risk factors, the possibility of residual or unmeasured confounding cannot be ruled out,” they wrote. Another limitation is that there were relatively few studies that looked at TV viewing and diabetes and cardiovascular disease risks and only four of them included type 2 diabetes. All of the included studies relied on participants to report their own TV viewing habits.

To be clear, the researchers did not design the study to determine whether TV viewing affects blood glucose levels. They were trying to assess the contribution of TV viewing to lifestyle habits that increase disease risk.

“Sedentary lifestyle, especially prolonged TV watching, is clearly an important and modifiable risk factor for type 2 diabetes and cardiovascular disease,” said Grøntved.

Background information in the study points out that TV viewing is linked to a growing sedentary lifestyle. On average, TV viewing within several European countries occupies 40 percent of daily free time. The number is 50 percent in Australia. This corresponds to a daily TV viewing time of about 3.5 to 4.0 hours. In the United States, the average number hours of TV viewing has recently been pegged at five hours per day. Add to that occupations that have people sitting at desks working on computers for eight hours a day and sleeping for five to seven hours and you end up with a total of 18-20 sedentary hours a day.

In addition, the researchers point out that beyond the reduced physical activity, TV viewing is also associated with unhealthy eating habits.

Surprisingly Little Mayo in the Mayo Clinic Diet

written by Michael O’Leary

If you’ve ever tried the Mayo Diet, chances are it was probably bogus. That’s because diets purporting to be the Mayo Diet have been introduced since the 1940s. Various versions have included the grapefruit diet and the cabbage diet. Many have been wildly popular.

The problem with all those diets however, is that the famed Mayo Clinic had nothing to do with developing them. It wasn’t until last year, in fact, that the Mayo Clinic decided to develop a weight-loss plan, which debuted in January 2010, called the Mayo Clinic Diet.

As you would expect from the renowned clinic, the diet has quickly won acclaim and this month was named by US News and World Report as one of the best overall diets and was a close second to the DASH diet for weight-management for diabetes patients.

Part of the reason is that the Mayo Clinic Diet – the real one – emphasizes a lifestyle approach, AND it takes a gradual approach to adopting a new lifestyle that will help you maintain a healthy weight for a lifetime.

The two-phase diet is based on the Mayo Clinic Healthy Weight Pyramid, which recommends servings and portions sized for each food group depending on your calorie goal. As an example, a diet with a daily calorie goal of 1,200 calories a day includes a menu of 4 servings of vegetables, 3 of fruits, 4 of whole grains, 3 servings of lean protein or low-fat dairy and 3 servings of healthy fats such as those contained in nuts or olive oil. The program uses the pyramid to introduce the idea of caloric density. The idea is that fruits and vegetables have a lot of bulk but not a lot of calories versus a pat of butter that has a lot of calories for the serving size.

The first phase of the diet, called “Lose It!” is designed to provide a quick motivational weight loss of 6 to 10 pounds within two weeks, and introduces concepts of serving sizes and exercise. It provides easy-to-remember serving sizes based on baseballs, tennis balls, hockey pucks and dice. Exercise starts with simply increasing physical activity to 30 minutes a day beginning with everyday activities such as cleaning the house or mowing the lawn.

“In the Lose It! program what we want people to do is to dive right in,” Dr. Donald Hensrud, preventive medicine specialist at the Mayo Clinic in Minnesota told CBN news. “It’s going to be challenging for awhile. But once you start seeing results right away, start having more energy, then it builds on itself and becomes easier to sustain over time.”

The second phase, called “Live It!” is designed to produce a gradual weight-loss of 1 to 2 pounds a week until you reach your weight goal. Included in this second phase is the gradual introduction of moderate exercise leading to more structured exercise such as paced walking and biking or swimming.

The key to the Mayo Clinic Diet is that it is not a diet with a beginning and an end; rather it is a strategy to change your lifestyle.

If you’re interested, there’s lots of different clinical research studies that are examining different diets.  To learn more, visit here.

 

All About Corengi On Clinical Trials Guru Show

Last week, the guys at www.theclinicaltrialsguru.com interviewed me about what Corengi does, why we do it, and how we eventually hope to support it.  The video’s pretty long – but if you’re interested (and have forty minutes to spare) – check it out below:

DASH Wins By A Nose In Comparison of Diabetes Diets

In a head-to-head comparison of dieting plans, the DASH diet won both for best overall diet and nosed out the Mayo Clinic Diet for best diabetes diet.

US News and World Report assembled a panel of 22 nationally recognized nutrition experts and asked them to rank 20 popular diets from Atkins to the Zone diet based on data from medical journals, government reports, and other sources. Over a six-month period, the experts rated each diet on a scale from 1 to 5 in seven categories: safety, short-term weight loss, long-term weight loss, how easy it is to follow, its nutritional completeness, its safety, its ability to prevent or manage diabetes, and its ability to prevent or manage heart disease.

The report ranked the Dietary Approaches to Stop Hypertension (DASH) diet, developed by the National Heart, Lung, and Blood Institute (NHLBI) as best overall and best for diabetes. Mayo Diet was a close second in the diabetes diet category.

The DASH diet is considered easy to follow because it uses common foods available in your grocery store. It emphasizes foods low in fat and cholesterol and boosts intake of fruits, vegetables, whole grains, low-fat dairy and lean meats including fish and poultry. It encourages cutting back on sodium, sweets, sugary beverages and red meats.

Interestingly, the DASH diet wasn’t designed to help adherents lose weight – it was designed to help people control their blood pressure.  That said, it was considered the most effective – both for dieters in general and people with diabetes in particular.

The diet plan rankings included such well-known diets as Jenny Craig and Weight Watchers as well as lesser-known plans such as the Glycemic Index Diet. Although the Glycemic Index Diet was designed specifically for weight-management for diabetes patients, it ranked 12th among diabetes diets.

While the panel couldn’t cover every plan people follow, they do plan to add more diets to the rankings in the future. In Best Diets 2.0, the panel said they also plan to release an interactive tool that will help you plug in detailed preferences and requirements to find the diets that fit you best.

 

 

Will Sanofi’s Lyxumia GetGoal Trials Result in Approval?

written by Michael O’Leary

Promising results may offer patients with type 2 diabetes a new treatment option if ongoing clinical trials continue to show similarly positive outcomes.  The news was recently reported by Sanofi – who is trying to get Lyxumia (scientific name: lixisenatide) approved.

But patients with diabetes should be cautious about company-released reports. Such press releases are often aimed more at selling stock than providing patients and doctors with useful information to judge the effectiveness of the drug. This is the second release about Lyxumia™ within a month by Sanofi.

The report said results of the recently completed GetGoal-L phase III clinical trial show that Lyxumia with or without metformin produced a significant reduction in HbA1c compared to placebo in type 2 diabetes patients. Perhaps just as encouraging, patients also lost weight. Because type-2 diabetes is associated with excess body weight, the results showing weight loss was an added bonus for study participants.

The GetGoal-L phase III clinical trial is one of nine studies in the GetGoal series of trials funded by Sanofi and its partners. It involved 495 patients who either received lixisenatide or placebo for 24 weeks. The only side effect reported in the press release was nausea that was generally not significant enough to cause participants to discontinue the study.

While the company did not release any of the study data, they did say the results confirmed the results of several other GetGoal trials. The GetGoal program of clinical trials have enrolled 4,300 patients to date and are aimed at securing approval to market the drug. The company expects to present the full study results from this most recent GetGoal-L at a medical meeting, but did not specify when or where.

Lixisenatide is a glucagon-like peptide-1 agonist or GLP-1 and is intended to compete with other GLP-1 agonist drugs, Novartis’ Galvus, Merck’s Januvia and AstraZeneca’s Onglyza, which are already FDA or EU approved. GLP-1 is a naturally occurring peptide that is released within minutes of eating a meal.

GLP-1 plays a role in a complex interaction of chemicals in the body that stimulate some hormones and suppress others to achieve the proper glucose levels in the blood. GLP-1 receptor agonists are add-on treatments for type 2 diabetes, meaning they are used in combination with other drugs used to control blood sugar.

There’s an ongoing trial that is recruiting for lixisenatide – but it is for patiets who have recently had some sort of acute coronary event.  More info here:  http://www.corengi.com/study/nct/NCT01147250

 

New Animated Video to Help Diabetes Patients Better Understand Clinical Trials

www.corengi.com simplifies clinical research with new educational video and matching engine to help diabetes patients identify suitable trials.

Seattle, WA – Corengi, Inc. today announced it has launched a new animated video entitled “What ARE Clinical Trials?” The new video – available at www.corengi.com – is a short, humorous program explaining many of the key concepts used in clinical research. Along with a number of other concepts, the video explains the different phases of clinical trials, highlights the differences between interventional and observational trials, provides examples of inclusion and exclusion criteria, and describes the purpose of an Institutional Review Board (IRB). Corengi produced the video to help the 27 million diabetes patients in the United States understand more about the convoluted process of clinical research.

While it does spotlight some aspects that are specific to diabetes, the video is an educational tool that anyone can use. Andrew Schorr, founder of PatientPower and author of The Web-Savvy Patient, endorsed the new video, commenting, “This can be used by anyone with any ongoing health concern where participating in clinical research should be one option to consider. As a trial participant from years ago, I wish I had seen this to help me better understand the clinical trial world.”

“The video helps explain in detail what a clinical trial is,” adds Cherise Shockley, founder of Diabetes Social Media Advocacy, a weekly Twitter chat and radio program. “It explains the who’s, the what’s and the why’s. This is a great way for anyone with diabetes to learn more about clinical trials.”

“This type of information is what patients need to make better-informed decisions and manage their healthcare options to enhance their lives,” explains Jake Fry, a director at Sound Medical Research, a clinical trial site in Washington State that conducts diabetes research.

“Among diabetes patients who have participated in a clinical trial, the vast majority describe it as a very positive experience,” concludes Ryan Luce, co-founder of Corengi. “The challenge is that many other patients don’t completely understand what clinical trials are and how they work. With this video, we hope to provide more insights into the process, and encourage more type 2 diabetes patients to consider them as an option.”

Corengi is committed to helping patients with diabetes understand more about clinical trials and help them find clinical trials that are right for them. To view the video or use Corengi’s clinical trial matching engine, please visit www.corengi.com.

The video is also available on youtube and can be embedded on other websites.