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Diabetes Core Update
Diabetes Core Update 6/10/2013
00:17:11
Diabetes Core Update is a monthly podcast that presents and discusses the latest clinically relevant articles from the American Diabetes Association’s four science and medical journals – Diabetes, Diabetes Care, Clinical Diabetes, and Diabet
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- [00:04]
A
Welcome to the American Diabetes Association Diabetes Core Update, where we will regularly keep you up to date on the latest clinically relevant articles from the American Diabetes Association's four science and medical journals, Diabetes, Diabetes Care, Clinical Diabetes and Diabetes Spectrum. Joining us for this program are Dr. Neal Skolnik, who is a professor of Family Medicine at Temple University School of Medicine and and associate Director in the Family Medicine Residency Program at Abington Memorial Hospital. Welcome, Dr. Skolnick.
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B
Thank you. It's a pleasure to be here.
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And Dr. John Russell, who is a professor of Family Medicine at Temple University School of Medicine and director in the Family Medicine Residency Program at Abington Memorial Hospital.
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Thank you. I'm looking forward to going over this week's articles.
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And now for the articles.
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B
We've another excellent issue this month, but you Beginning with an article from Diabetes Care on the effect of bariatric surgery in patients who do and do not meet the traditional NIH criteria for bariatric surgery. Then an article on diabetes and fracture risk, followed by an article on Once weekly exenatide vs insulin detymir, then a discussion of the Look Ahead study and the effect of intensive life flow, lifestyle modification on fitness, weight loss and a 1C and finally two articles on the relationship between vitamin D and the development of diabetes. Our first article is from the May issue of Diabetes Care on the evaluation of current eligibility criteria for bariatric surgery. The criteria for bariatric surgery was established by the National Institute of Health in 1992 and is still the most widely used criteria. According to these criteria, eligible individuals should have a BMI greater than or equal to 40 or a BMI between 35 and 40 if they have high risk comorbidities such as severe type 2 diabetes or cardiovascular risk. This study, the Swedish obese subjects, the SOS study, which is published a lot on bariatric surgery, looked at over 2,000 obese individuals who underwent bariatric surgery. 68% of them were vertical banded gastroplasty, 19% banding and 13% were gastric bypass and 2,000 matched obese controls. At inclusion, the participants were 37 to 60 years of age and BMI was greater than or equal to 34 in men and greater than or equal to 338 in women. Surgery in this study was assessed both in patients that met the NIH criteria and those who did not meet the criteria. Over 200 patients who did not meet the criteria with a medium of 10 years of follow up cardiovascular risk factors were significantly improved in both patients who wouldn't have been eligible under NIH criteria and those who would have been after 10 years of follow up surgery reduced the incidence of diabetes in both non eligible and eligible patients by approximately 70% with no difference between the two groups.
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John so certainly obesity is an epidemic and has been an epidemic in the United States. And bariatric surgery in certain ways has been a revelation in that not only does it help people with weight loss, it actually helps has been known to cure diabetes. And certainly when you're going to do any big procedure that's going to cost a lot of money, it makes some sense to have some guidelines to determine who can have the surgery done and who cannot. And certainly looking at the study, it would say a lot of the people who do not meet the criteria as of today would certainly benefit from this. Now, one could argue is this just going to be a self serving thing and is this going to be that everyone whose BMI is three points above normal is going to have to have a surgery done? But no. But if you look, if you're looking at the big picture, even economically, if you prevent all these people from developing diabetes, how much dialysis down the road are you going to prevent? How much blindness are you going to prevent? How much heart disease are you going to prevent? How many premature deaths are you going to prevent? So certainly it makes some sense. And not all of these procedures were full roux en Y's, they were sleeve procedures, they were vertical band gastrectomies. So I think we're going to see that whatever the guidelines are for bariatric surgery, it's going to change and I think probably for the better. Our next article is from diabetes care, the May 2013 addition and it looked at diabetes and risk of fracture related hospitalizations. The Atherosclerosis Risk in Communities Study the researchers wanted to examine the association between diabetes glycemic control and risk of fracture related hospitalization. In this particular study, they calculated the incidence rate of frascular related hospitalization by age and used proportion hazard models to investigate the association of diabetes with the risk of fracture after adjusting for demographics, lifestyle and behavioral risk factors. In studying this, they found close to 1100 incident fracture related hospitalization among the 15,000 participants that were followed for 20 years. Diagnosed diabetes was significantly and independently associated with an increased risk of fracture with a hazard ratio of 1.74. There was also a significantly increased risk of fracture among patients with diagnosed diabetes who were treated with insulin with a hazard ratio of 1.87 and patients with diabetes and hemoglobin A1C greater than 8 with a hazard ratio of 1.63 compared to those who had hemoglobin A1C of less than 8.
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Neil John, I think this is potentially a very important study because remember treatment of osteoporosis and detection of osteoporosis. The current guidelines by the United States Preventive Service Task Force recommend that that we don't test everyone with a DEXA scan who's over 50, women over 50 or past menopause, but rather we use a validated prediction tool, the FRAX score to assess a woman's risk for fracture and when that risk is greater than that of an average white 65 year old woman that's when we should be checking with a DEXA skin or women over 65. The problem with the FRAX score is it doesn't include every potential risk factor and relevant to this article. It doesn't include diabetes, it includes parent history, it includes individuals risk or experience of previous fracture, current smoking, steroid use, but importantly doesn't include diabetes. And what we're seeing from this study is that patients with diabetes may have approximately a 70 to 80% age increased risk of fracture that might not all be due to osteoporosis but may be strongly contributed to by osteoporosis. So I think from a practical point of view this study alerts us that patients with diabetes are at increased risk increased fracture risk and we might think about screening those patients for osteoporosis at an age that is younger than that which they would otherwise be screened. Our next study from Diabetes care is on once weekly exenatide versus once or twice daily insulin dety me. In this study 216 patients were randomized to once weekly exenatide, 2mg or detymir given once or twice daily titrated to achieve a fasting plasma glucose less than or equal to 5.5 millimoles per liter for 26 weeks. The primary outcome was the proportion of patients achieving an A1C less than or equal to 7% and weight loss greater than or equal to 1 kg at the end of the study. Overall 44% of exenatide treated patients compared with 11% of dedomir treated patients achieved the primary outcome with a P value less than 0.0001. Treatment with axenatide resulted in significantly greater reductions than denim and in A1C a reduction of negative 1.3% versus negative 0.88% with a P value less than 0.0001 and weight losing 2.7 kg versus gaining 0.8 kg. GI related and injection site related adverse events occurred more frequently with Exenatide than with Detymir Shawn.
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So the GLP1 receptor agonist would really seem to be a very perfect medication, especially one that you could give once a week. So it's exciting to look at this that compared to once or twice daily insulin injections, someone giving themselves an injection once a week in fact did just as well blood sugar wise and in fact had some weight loss associated with it. Very exciting. I think the thing to point out though is the GI side effects were twice as common with the exenatide and in fact twice as many people had to drop out of this study as opposed to in the insulin arm. So this particular medicine or other medicines in the class that might be once a day might be a nice alternative for our patients who need some better glycemic control without hypoglycemia with some weight loss. There are some more GI concerns with these medicines, so I think if someone can tolerate them, I think this should be something we should be considering kind of putting in our work pail for taking care of diabetes. Our next article is from the May 2013 edition of Diabetes Care. The Look Ahead trial a four year change in cardiovascular fitness and an influence on glycemic control in adults with type 2 diabetes in a randomized trial so this randomized trial looked at subjects who were overweight or obese with type 2 diabetes with available fitness data at four years, which was roughly around 4,000 people. Patients were randomized to either diabetes support and education or intensive lifestyle intervention. Subjects received the standard care plus information related to diet, physical activity and social support three times a year. The intensive lifestyle intervention subject received weekly intervention contacts for six months, which was reduced over the four year period and they were prescribed diet and physical activity. All patients had measured weight, fitness, physical activity and A1C. The researchers found the difference in percent fitness change between the intensive lifestyle intervention and diabetes support and education at four years was significant after adjusting for baseline fitness and a change in weight at 4 years, physical activity increased by 348 kilocalories per week in the Intensive Lifestyle Intervention Group versus 105 kilocalories per week in the diabetes support and education group. The fitness change at 4 years was inversely related to the change in A1C after adjusting for clinical site treatment, baseline A1C prescribed diabetes medication, baseline fitness and weight change Neil John we're going to.
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Be seeing a lot of information come out of the Look Ahead trial, one of the largest trials of intensive of lifestyle modification that has ever been done. And I think it's really important to put the results in perspective because remember, in the fall of this year, the NIH announced that the trial was stopped because of futility in reaching its endpoints of decreased cardiovascular disease. But remember, those endpoints aren't the only ones that we look at. And it's possible that those endpoints weren't reached because we've done so well in treating both all of our patients, both the intensive lifestyle group and the regular group with things like statin and blood pressure control, that the total number of endpoints were less than would have expected. But there are a lot of intermediate endpoints that the intensive lifestyle modification group really showed important effects. And this is one intensive lifestyle modification, meaning diet and exercise really achieved what you expected it would, which is, as this trial went over, the decreased weight, improved fitness, improved physical activity and with improvement of fitness and decreased weight improvement in A1Cs. And if we can help our patients feel better with fitness and improve their A1Cs without additional use of medicines, then clearly we've made some important effects for them. For our last set of articles, we're going to talk about two articles looking at the effect of vitamin D levels on development of diabetes. The first was a historical prospective cohort study of individuals culled from a data set of nearly 4 million people looking at patients who were either diabetes or who had impaired fasting glucose. The baseline included over 100,000 adults, 80,000 of which had normal glycemia and 34,000 had impaired fasting glucose. What this study showed was an inverse association between vitamin D serum levels and the risk of progression to impaired fasting glucose and diabetes, meaning the lower your vitamin D levels were, the greater the chance was that you would progress to diabetes. The next study that we're going to look at was a Meta analysis of 21 prospective studies that included over 75,000 participants, yielding almost 5,000 cases of diabetes. When those participants were followed over time comparing the highest to the lowest categories of vitamin D levels, the relative risk for development of diabetes was 0.62. Or to say it a different way, in those with the highest serum level of vitamin D versus those in with the lowest, there was a 38% decrease in the risk of developing diabetes over time.
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John so once again, another vitamin D study that potentially is associated with some horrible disease. So certainly we've looked at vitamin D being low, vitamin D levels being associated with increased rate of heart disease, increased rate of cancer, increased rate of chronic pain and in these studies increased rate of developing diabetes and certainly people with low vitamin D levels. It certainly might be a surrogate marker that that these are some folks who have some overall kind of poor health at present. Perhaps they are going to be sicker in the future. But what you certainly would like to see in any type of study is that if you actually corrected someone's vitamin D level and then followed people forward would there be less diabetes developing? And I think that's a bit of a reach to say that if we fix this one surrogate factor other things are going to correct themselves. So I think certainly this goes in the bucket of you know diseases that vitamin D, low vitamin D levels are associated with but causality I still think is a leap of faith.
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For more information and links to the articles that we discussed in this issue just go to www.wwwdiabetesjournals.org until next week, keep listening and keep learning.