Archive for December, 2010

FDA Panel Green-Lights Contrave for Obesity

December 31st, 2010 | 1 Comment | Source: ABC News, LA Times

The FDA has been tough on diet drugs of late. Three years ago, it scuttled an attempt to get the European diet drug rimonabant approved for use in the US. More recently it rejected, at least temporarily, applications for Qnexa and Lorcaserin.

obesity2 200x300 FDA Panel Green Lights Contrave for ObesityBut that trend may have been reversed last week, when an advisory committee set the stage for possible FDA approval of Orexigen’s investigational diet drug, Contrave. By a 13-7 vote, the committee said in essence that the somewhat modest beneficial effects of the drug outweighed its tendency to increase blood pressure.

The FDA will make final decision on the matter by the end of January. It is not required to follow the advice of its advisory committees, but as was the case for the 3 diet drugs mentioned above,  it usually does.

Orexigen has petitioned the FDA to approve Contrave for the treatment of obesity and weight management in people who have a body mass index of at least 30, or at least 27 if they have at least one cardiovascular disease risk factor like diabetes, high cholesterol or high blood pressure.

Contrave is a combination of 2 drugs that were approved long-ago by the FDA and are widely used today. Naltrexone, the first of these, is used to treat opioid addiction and alcohol dependence. The second, bupropion, is used to treat depression and as a quit-smoking aide.

Before reaching its verdict, the FDA’s Endocrine and Metabolic Drugs Advisory Committee reviewed the results of 4 randomized trials that were sponsored by Orexigen. Together, the studies enrolled more than 4,500 overweight and obese subjects. The Committee noted that in pooled results from the 4 trials, the weight-loss difference between those receiving Contrave and those receiving a placebo was about 4.2%, which it deemed to be “of nominal statistical significance.” However, more than a third of subjects in the Contrave group did lose least 5% of their body weight during a 1-year follow-up period.

“As far as efficacy goes, I think they made it by the hair of their chinny chin chin,” Melanie Coffin, a patient representative on the Committee told ABC News.

The Committee did raise concerns about several side effects of Contrave, including seizures and suicidal ideation, although it was clearly most concerned about the drug’s tendency to increase blood pressure, a phenomenon that seemed to be most apparent in the first few weeks after the drug was started. Ultimately though, the Committee decided there wasn’t enough data to draw clear conclusions about the cardiovascular risks of Contrave. It did recommend that Orexigen should submit post-market data on the matter, if and when it receives full FDA approval.

Currently, the only anti-obesity drug on the market is Orlistat (also known as Xenical and Alli). Recently, Abbott pulled another one, sibutramine (Meridia) after mounting evidence suggested it was associated with strokes and heart attacks.

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Feds to Offer Prize Competitions

December 29th, 2010 | No Comments | Source: Wall Street Journal, whitehouse.gov

Lost amid coverage of the repeal of Don’t Ask Don’t Tell and passage of a new START treaty, the lame-duck Congress passed the America Competes Act last week. Although the move didn’t receive much coverage by the press, it is quite significant in its own right.

prize Feds to Offer Prize CompetitionsIn what could turn out to be a decisive move in the effort to leverage American ingenuity and innovation, America Competes empowers all federal agencies to sponsor prize competitions to spur innovation, solve their most difficult problems, and advance their missions.

Prize competitions have been shown to be effective as a strategy to energize our nation’s innovators. The private sector and philanthropists use them quite often. According to a study by McKinsey  in fact, more than 60 prizes valued at $100,000 or more were introduced by such organizations between 2000-2007. Total prize money associated with these competitions approached $250 million.

Perhaps the best known among these are the competitions sponsored by the X Prize Foundation, a nonprofit organization that works with philanthropists and the private sector to foster innovation by offering enormous cash prizes to those who solve key technological challenges. In September, for example, it awarded a $10 million prize to 3 teams who created a production-ready car that got 100 miles per gallon (or an energy equivalent).

The X Prize Foundation has established similarly sized prizes for groups that achieve specified cost and speed targets in the area of gene sequencing, and a $30 million prize for the first private group that lands and operates a rover on the moon.

And as Eric Hintz points out, America Competes is not the first example of government-sponsored innovation challenges. In 1714, Hintz writes, the British Parliament offered prizes to those who would develop a means to calculate longitude at sea. It took awhile, but eventually John Harrison won nearly £14,315 for his marine chronometer. And in 1800, the French government created a Food Preservation Prize as a means to help supply food to Napoleon’s army. A decade later, Nicolas Appert won 12,000 francs for a vacuum-packing process, that is used for canned foods to this very day.

Innovation1 300x287 Feds to Offer Prize CompetitionsUntil now however, the federal government had not implemented a prize-oriented open innovation strategy

But, as summarized in a post by Tom Kalil and Robynn Sturm on the Open Government Initiative blog, President Obama triggered momentum to change that when he floated the idea as part of his 2009 proposal titled, Strategy for American Innovation. Then, 6 months after a March, 2010 memo from the Office of Management and Budget confirmed the Administration’s commitment to the new approach, the White House and the General Services Administration “launched Challenge.gov, a one-stop shop where entrepreneurs, innovators, and citizen solvers can compete for prestige and prizes by providing novel solutions to tough national problems, large and small.”

In just 3 months since the launch, Challenge.gov helped 27 federal agencies release 57 challenges on topics ranging from childhood obesity and Type 1 Diabetes to advanced vehicle technologies and financing for small businesses.

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Frankly, I can’t remember a more creative, dynamic initiative coming out of Washington. Innovation is in this country’s DNA. It has helped make our country great. In today’s increasingly competitive global economy, we need it more than ever. Moreover, prize competitions, whether sponsored by governments or other entities, do work. They allow sponsors to exponentially increase the number and diversity of people that are focused on the toughest of challenges.

And as Hintz said, the sponsor pays only for positive results. Nice work, fellas!

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Heart Healthy Habits: They Matter in Kids

December 28th, 2010 | No Comments | Source: Circulation, Wall Street Journal

Maybe it’s time to bring Junior in for a heart check-up.

Heart attacks are vanishingly rare in kids and adolescents, but a growing body of literature suggests that the seeds of heart problems later in life are sewn in this age group. Two studies published recently in Circulation lend further credence to this idea.

9999togo 201x300 Heart Healthy Habits: They Matter in KidsIn the first of these, Markus Juonala and colleagues at Finland’s Turku University Hospital followed a cohort of 4,380 people from a very young age through their 40s, and found that high systolic blood pressure, high cholesterol levels and a high body mass index in—get this—kids as young as age 9 are strong predictors of arterial wall thickening more than 3 decades later. This thickening is good non-invasive evidence of arteriosclerosis, the proximate cause of heart attacks and strokes.

Interestingly, Juonala’s group found that the presence of these risk factors at either age 3 or age 6 did not have a similar predictive value for problems later in life.

The second study, by Mika Kähönen and colleagues of Tampere University Hospital (also in Finland) used a similar longitudinal design. This group essentially proved that what your mother has been telling you all these years is correct: kids who ate fruits and vegetables at least once per day turned out to have healthier arteries when they became young adults than those who consumed these heart healthy foods twice a month or less.

Both studies relied on an arterial pulse wave velocity test to assess arterial wall thickening.

The results of these studies support many earlier ones which have indicated that all those well-established cardiac risk factors start kicking-in between the ages of 8 and 10. And yes, they do suggest it might not be a bad idea to get Junior checked for cardiac risk factors about the time he enters 4th grade.

The visit might include a blood pressure check, a cholesterol test, an assessment of the body mass index and a careful history covering exercise, diet and exposure to second-hand cigarette smoke. That said, it’s essential to seek guidance on the meaning of this visit from your doctor, since norms for these tests and historical factors aren’t as well established for kids as they are for adults.

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Resveratrol: Is the Honeymoon Over?

December 27th, 2010 | 2 Comments | Source: Fierce Biotech, Myeloma Beacon

Resveratrol, a naturally-occurring antioxidant found in blueberries, red grapes and red wine, had become a press-magnet over the last few years after studies showed it activated so-called Sirt1 metabolic pathways which control the differentiation, aging and death of mammalian cells.

lifesavers 200x300 Resveratrol: Is the Honeymoon Over?The studies prompted scientists to speculate that resveratrol can be leveraged to fight cancer or even create a modern-day Fountain of Youth.

Amid the excitment, GlaxoSmithKline shelled-out $720 million to purchase Sirtris Pharmaceuticals, a Boston-based company that owned key patents in the area and that was headed by a controversial Harvard researcher, David Sinclair. Sinclair reportedly pocketed $8 million in the deal.

Alas, things haven’t gone well for GSK since the purchase. Last month in fact, the drug giant announced it was pulling the plug on further development of SRT 501, one of the proprietary resveratrol formulations it acquired from Sirtris.

GSK officials said at the time that the drug’s potential to cause harm outweighed any possible benefits, at least in relation to the treatment of multiple myeloma, a bone marrow cancer.

The announcement came a few months after GSK shut down a Phase 2 trial of the compound when several patients developed kidney failure.

The Myeloma Beacon, a blog that follows scientific advancements relevant to multiple myeloma, first broke the story. A GSK spokesperson told the Beacon that its decision allows the company to reassign development resources towards other resveratrol compounds with a more favorable risk/benefit ratio. The newer compounds are not being considered as treatments for myeloma.

“Currently, we have two of these latest generation compounds (SRT2104 and SRT2379) in several exploratory clinical trials,” the spokesperson added.

The GSK spokesperson did not indicate why the company decided to bag research on SRT501 altogether. Certainly, it could have continued to assess the compound for efficacy against other diseases.

Earlier scientific claims about resveratrol were based on laboratory studies involving mice and other rodents. GSK’s trial of SRT501 in myeloma patients was the first trial of the drug in humans.

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Physical Attractiveness and the Job Search

December 24th, 2010 | 1 Comment | Source: NY Times

Throughout recorded history, men and women—particularly the latter—have sought ways to enhance their appearance. Egyptians used eye shadow and painted their faces. So did the Greeks and Romans. Tattoos and body piercings have been used by people in many cultures for centuries. The goals of these efforts include finding a suitable mate, increasing self-confidence and signaling wealth or power.

interview Physical Attractiveness and the Job SearchBut as women slowly gain equal footing in the workplace, it’s appropriate to ask whether such efforts have a positive impact on their careers. Recently, economists Bradley Ruffle and Ze’ev Shtudiner examined one aspect of this matter by designing a study to assess the impact of physical attractiveness on success during a job search.

Their study revealed that good looks help men who are looking to secure a job interview, but they have a negative impact on women who are after the same thing.

To reach these conclusions, the scientists distributed 5,000 résumés to 2,600 Israeli employers that had advertised job openings. They sent 2 nearly identical résumés to each employer; one contained a photograph of the job-seeker, and the other did not. In some cases, the photo showed an attractive person; in others, the photo showed a plain-looking person.

Judgments about the attractiveness of the people in the photos were made by men and women that were not affiliated with the investigators. The photos included pictures of people with apparently mixed ethnic backgrounds to remove any possible effects of racial bias.

The employers reached-out to request an interview from 14.5% of the job candidates, overall. Among the male candidates, 13.7% with plain-looking photos, and 19.9% with attractive photos  were contacted to set-up an interview. Only 9.2% of those whose resumes contained no photo were called-in.

The results were strikingly different for women, in whom 16.6% who didn’t send a photo were invited for an interview, as compared with 13.6% of those who had submitted a plain-looking photo and 12.8% of those who had submitted an attractive-looking photo.

Interestingly, none of these differences was noted when employment agencies were responsible for deciding who would be interviewed. The differences were present only when the applications were sent directly to the hiring company.

A post-study analysis revealed that in companies that did their own hiring, young, typically single women were responsible for screening those resumes. When questioned by the scientists, these company-based screeners indicated that when a man included a photo, it showed confidence and helped assure that the candidate was “presentable.” When a woman did the same, the screeners perceived it negatively; the woman was “attempting to market herself via her appearance.”

The economists concluded that company-based personnel responsible for hiring new staff appear to discriminate against attractive women and that “female jealousy” was the most likely explanation for this.

“Our results show that beauty distorts the hiring process,” the researchers wrote. “Suitably qualified attractive women and plain men and women may be eliminated early on from the selection process.”

The write-up appears on the Social Science Research Network.

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Primary Care Docs’ Early Career Income is Bupkis

December 23rd, 2010 | No Comments | Source: Amednews

If the Affordable Care Act works like it’s supposed to, 32 million Americans will obtain health insurance for the first time over the course of this decade. Authors of the health reform law expect primary care physicians (PCPs) to care for most of these people. Unfortunately, the nation’s severe and worsening PCP shortage means these expectations are unrealistic.

broke Primary Care Docs Early Career Income is BupkisHow big is the PCP manpower problem? The Association of American Medical Colleges estimated we’d be short 45,000 of ‘em by the end of this decade, and that was before the Big O signed the Affordable Care Act into law.

Many studies have linked the dwindling supply of PCPs to long work-hours, administrative hassles and most importantly, a widening income gap between PCPs and specialists.

A recent study by Martin Palmeri and colleagues at Dartmouth has shed light on one aspect of this income gap: the excessive debt burden faced by PCPs in the first years after they complete residency training.  

To quantify the early-career financial situation for PCPs, Palmeri’s group developed a net income and expense model based on data from the 2007 Physician Compensation Survey and several other databases. Their model looked at physician reimbursement, medical student debt, college savings, retirement planning and cost-of-living expenses.

The scientists found that in contrast to specialists, most PCPs do not earn enough in the first 3 to 5 years post-residency to cover expenses.

PCPs who deferred loan payments until after residency averaged $199,159 in debt, the scientists found. To pay this off in 10 years, they had to fork-out monthly payments of $2,261. When their debt repayment was combined with housing costs, retirement savings, children’s college savings and other expenses, PCPs ended-up $801 short each month, assuming their average starting salary was $130,000. This doesn’t even include the costs of entertainment, clothing and travel expenses.

In the researchers’ model, the only way PCPs ended-up with a net positive income in the first 3-5 years after residency was if they had no debt coming out of medical school or exhibited a lifestyle considered by the researchers to be “optimal low cost” (Mad Men reruns on a Saturday night, anyone?).

The sliver of good news in the study was that PCP income did rise quickly during those first few years, but the scientists were unequivocal in their conclusion: the short-term financial realities faced by primary care physicians create strong disincentives to the pursuit of a career in that field.

Palmeri himself is training to be an Oncologist, by the way. His study appears in the November issue of Academic Medicine.

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Playing Tetris Cuts Flashbacks in PTSD

December 22nd, 2010 | 2 Comments | Source: BurrillReport, PLoS Medicine

Flashbacks are vivid, recurring, intrusive and unwanted mental images of a past traumatic experience. They are a sine qua non of Post-Traumatic Stress Disorder (PTSD). Although drugs and cognitive/behavioral interventions are available to treat PTSD, clinicians would prefer to utilize some sort of early intervention to prevent flashbacks from developing in the first place. 

tetris Playing Tetris Cuts Flashbacks in PTSDWell, researchers at Oxford University appear to have found one. Remarkably all it takes is playing Tetris. Yes, Tetris!

The team responsible for the discovery was led by Emily Holmes. The write-up appears in the November issue of PLoS One. Holmes and colleagues had reasoned that the human brain has a limited capacity to process memories, and that memory consolidation following a traumatic experience is typically complete within 6 hours after the event. Holmes’ team also knew that playing Tetris involved the same kind of mental processing as that involved with flashback formation. So they figured if they had people play Tetris during that 6-hour window after the traumatic event, it might interfere with memory consolidation of the traumatic experience. That in turn, would reduce or eliminate the flashbacks.

The idea worked like a charm.

The Experiment: Holmes’ team had 40 subjects watch a 12-minute film depicting traumatic scenes of injury and death, and then randomized the group to either play the classic video game after the movie ended, or to sit there and do nothing. The groups were similar with respect to age, gender and pre-existing psychological make-up.

Subjects in both groups kept track of any flashbacks for a week using a diary. Then, they underwent a formal clinical assessment and various memory tests.

The scientists observed that Tetris appeared to act like a “cognitive vaccine.” Subjects who played the game after watching the movie had fewer flashbacks during follow-up. Amazingly, the Tetris players’ memory of the movie and the associated trauma was the same as the control group. They just had fewer flashbacks.

Extra Credit: To elucidate the mechanisms behind Tetris’ beneficial impact, Holmes’ group performed a follow-up study comparing Tetris with Pub Quiz in a head-to-head match-up. The latter computer game has different mental processing demands than Tetris, and it turned out to actually increase the frequency of flashbacks and other PTSD symptoms.

The authors hypothesized that discussions and debriefing sessions, which constitute the traditional therapeutic intervention in the immediate (that is, within 6 hours) aftermath of a traumatic experience may actually do more harm than good. That’s because these interventions may actually enhance memory consolidation of the traumatic event.

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Time for your Cocktail, Edith!

December 21st, 2010 | No Comments | Source: Wall Street Journal

Studies about the health effects of alcohol always make headlines.

And it’s remarkable how complicated those health effects have turned out to be. In a 2-week period last September for example, the press covered 2 negative studies and 1 positive study about the health impact of alcohol: on down side were studies showing that consuming one lousy alcoholic beverage per day increased the risk of cancer in women, and that that people who consumed 2 or more alcoholic drinks per day had a 22% higher risk of pancreatic cancer. On the up side was a study showing that moderate drinking was associated with a reduced the risk of dementia.

KonTikiLuau 300x216 Time for your Cocktail, Edith!Well guess what, Edith? Scientists have presented, and the press has duly covered, 2 more studies on the health effects of alcohol. And both of them were positive!

Edith? Edith? Are you listening?

In the first, Qi Sun of Brigham and Women’s Hospital looked at 14,000 women from the Nurse’s Health Study, 1,440 of which had survived to age 70 without cardiac disease or cancer, and without memory problems or physical impairments. He compared alcohol consumption during midlife in this healthy cohort with that in women who had one or more chronic diseases, or mental or physical limitations. He found that the women who downed one or two drinks on most days of the week were 28% more likely to be members of the healthy cohort than women who drank no alcohol at all.

The second study focused on the risk of stroke. It also relied on data from the Nurse’s Health Study. In this instance, scientists looked at 73,000 women with no history of heart disease or cancer at the time they enrolled in the study. Going forward from their enrollment date, women who consumed an alcoholic beverage per day had a 20% lower risk of stroke than their tea-totaling counterparts. Alcohol intake higher than one drink per cay conferred no additional benefits. Interestingly, women who took hormone-replacement therapy and who consumed at least 2 drinks per day had a slightly increased risk of stroke.

The Nurses’ Health Study has enrolled over 200,000 women since its inception 35 years ago. It provides a good data set for studies like this because staff personnel obtain detailed histories about alcohol intake at regular intervals. This reduces errors caused by faulty memory.

Both the above studies were presented at the annual meetings of the American Heart Association last month. The AHA and other groups recommend that women should consume no more than one drink per day (for men, it’s two), and that no one should start drinking alcohol in order to gain these health benefits, since by all accounts they are small.

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Blood Supply Testing and Chronic Fatigue Syndrome

December 20th, 2010 | 2 Comments | Source: Science, Wall Street Journal

One year ago, researchers at the National Cancer Institute published a paper that linked Chronic Fatigue Syndrome with an obscure retrovirus known as XMRV. The article caused a stir because 4% of the supposedly healthy people in the study were infected with the virus. That could mean nearly 12 million Americans are infected with a poorly understood virus that potentially causes a poorly understood disease.

whichonewillgetAlzheimers 300x201 Blood Supply Testing and Chronic Fatigue SyndromeThere has followed a mad dash to commercialize a blood test for XMRV, since arguably, the nation’s blood supply needs to be screened for the virus. Unfortunately, progress on this endeavor has been slow.

Like HIV-the virus that causes AIDS-XMRV is a retrovirus. XMRV has also been associated with prostate cancer, although no one really knows whether the virus causes diseases of any kind in humans.

Labs involved the effort to develop an XMRV blood test include those at the CDC and the National Cancer Institute, as well private sector programs at Roche, Abbott and Gen-Probe.

Scientists at Abbott are working with the Cleveland Clinic and Emory University. They have created unequivocally positive blood samples from monkeys that were deliberately infected with XMRV. The infected monkeys produced antibodies to 3 proteins on the surface of the virus, but blood levels of these antibodies became undetectabe within weeks after the infection. Tests based on these antibodies can therefore generate false negative results. False negative results can also be caused by the unusually long delay between the time the monkeys were infected with the virus and the time the antibodies appeared.

Even if these issues can be overcome and the antibody test subsequently proven to be useful on human blood, there would remain additional challenges in commercializing the test. For example, the elapsed time between when the blood is obtained and when it is tested could impact test results.

“When there is a new agent that we don’t know a lot about, it’s always a process,” Michael Busch lamented in an interview with the Wall Street Journal. Bush is the director of San Francisco’s Blood Systems Research Institute and a participant in the working group tasked by the Feds to study the potential impact of XMRV on the nation’s blood supply.

Final Thought: It’s hard to criticize a proactive effort to commercialize a blood test for a virus that could be contaminating our nation’s blood supply, but it sure would be nice to know that XMRV actually causes human disease, and that it actually can be transmitted through a blood transfusion. #CartBeforeTheHorse?

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New Exercise Regimen for People with Type 2 Diabetes

December 17th, 2010 | No Comments | Source: JAMA, Medical News Today, MedPageToday

Scientists have known for years that people with type 2 diabetes can benefit from exercise, although the precise roles played by aerobic exercise and resistance training have been somewhat of a mystery. Until now, that is.

Runningshoes 300x254 New Exercise Regimen for People with Type 2 DiabetesIn a paper published last month in JAMA, Timothy Church and colleagues from LSU showed that type 2 diabetes patients benefit more from an exercise regimen that combines the 2 forms of exercise than programs based on either one, alone.

To assess the relative effects of aerobic training and resistance training, Church’s group studied 262 sedentary male and female patients that had type 2 diabetes. In the 9-month study, dubbed HART-D, the average age of the patients was 56. They had diabetes for an average of 7 years. Their average HbA1c level was 7.7%, indicating moderately well controlled diabetes at study onset. Nearly half the patients were not Caucasian.

The scientists randomized enrollees into a non-exercise control group, a resistance training only group, an aerobic training only group, and a group that underwent combined aerobic and resistance training.

Participants in the 3 intervention groups spent about 140 minutes in supervised exercise per week, including time spent warming-up and cooling-down. Aerobic exercise involved walking fast enough on a treadmill to burn 12 kcal/kg per hour. Resistance training was divided into 3 sessions per week, and focused on the upper body, legs, abs and back. Participants in the combination training program engaged in resistance training only twice per week in order to keep total exercise time the same as the other groups.

The scientists found that the absolute change in HbA1c in the combination group compared to the control group was -0.34%. This compared favorably with an absolute change of -0.16% and -0.24% for the resistance only and the aerobic only groups.

gettinbigwithrivaroxaban 300x187 New Exercise Regimen for People with Type 2 DiabetesChurch’s group estimated that if such reductions were maintained for years, people with type 2 diabetes would reduce the risk of cardiovascular disease risk by 5% to 7% and the risk of microvascular complications by 12%.

Of great significance, Church’s group also noted that the frequency with which oral hypoglycemic drugs had to be increased was 18% in the combination group. This was significantly lower than the 22% for the aerobic training only group, 32% for the resistance training only group, and 39% in the controls. Without these aggressive interventions, the absolute improvements in HbA1c levels in the combined exercise group would almost certainly have been much greater, according to the scientists.

All exercise groups reduced waist circumference by about the same amount [-.75 to -1.1 inches] when compared to the control group.

In an accompanying editorial, Canadian researchers, Ronald  Sigal and Glen Kenny concluded that, “based on the results of the HART-D trial, patients with type 2 diabetes who wish to maximize the effects of exercise on their glycemic control should perform both aerobic and resistance exercise. The HART-D trial clarifies that, given a specific amount of time to invest in exercise, it is more beneficial to devote some time to each form of exercise rather than devoting all the time to just one form of exercise.”

One note of caution: Although this is clearly good news, the study may not be easily generalizable to the population at large because the study design required that all exercise sessions be supervised.  It turns out that without that pesky trainer and the forced adherence to an exercise regimen, many folks, whether they have diabetes or not, can’t manage to stick with an exercise plan.

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