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Diabetes Core Update
Diabetes Core Update April 2015
00:22:27
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...
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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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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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We have another excellent issue this month, beginning with an article from Diabetes Care on bariatric surgery and its effect on insulin cessation. Then an article also from Diabetes Care on the pharmacokinetics of insulin glargine 300 units per milliliter versus glargine 100 units. Then an article on high intensity interval training for patients with diabetes from Diabetes Spectrum. Then an article on cutaneous manifestations of diabetes from clinical diabetes, followed by an article from Diabetes Care on saxagliptin and cardiovascular outcomes in diabetes and renal impairment. And lastly an article, an important article on tight glycemic control in a VA population and the use of hypoglycemic medications in veterans older than 65 years of age with dementia and type 2 diabetes.
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Our first article is from Diabetes Care and it looked at insulin cessation and diabetes remission after bariatric surgery in adults with insulin treated type 2 diabetes. So in this particular study they looked at over 100,000 patients in the Bariatric Outcome Longitudinal Database. Of that 10% of the patients had type 2 diabetes. They looked at the patients and compared the folks who had a Roux en Y gastric bypass for the folks who had a LAP adjustable gastric band and they followed them for outcomes for at least a year in folks who are already on insulin. Of the insulin treated type 2 patients who underwent a Roux en Y, 62% were off insulin at 12 months compared with 34% after a laparoscopic adjustable gastric banding procedure. In the case mass analysis at three months, the proportion of insulin cessation was significantly higher in the Roux en Y group than the lap band group and diabetes remission rate was higher at all time points after the Roux En.
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Yes, Neil John, this is a really interesting study in 2012, there were two studies that were reported in the New England Journal that showed that bariatric surgery led to about two thirds of patients with diabetes who had had diabetes for five to eight years to go into remission, meaning to drop their A1Cs below six, along with withdrawal of medicines. That wasn't a group who were necessarily on insulin. This study is particularly interesting because it's looking at patients on insulin. And again, depending on which procedure is used, between 30 to 60% of people were able to get off of insulin.
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C
Really?
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What does this mean? I think it means that for patients who have BMIs over 35 who are particularly difficult to control on insulin regimens, really bariatric surgery is on the map as something to seriously consider as a method for gaining control of diabetes and decreasing A1Cs. Our next article is on a new insulin glargine, 300 units per ML, providing a more even activity profile and prolonged glycemic control at steady state compared with insulin glargine 100 units per milliliter. The objective of this study was to characterize the pharmacokinetics and pharmacodynamics of a new insulin glargine comprising 300 units per milliliter compared with standard insulin glargine, which is 100 units per milliliter at steady state in people with type 1 diabetes. This was a randomized double blind crossover study with 30 people at steady state insulin concentrations and glucose infusion rate. Profiles of Glargine 300 were more constant and more evenly distributed over 24 hours compared to those of Glargine 100, lasted longer and was supported by the time to 50% of the area under the serum insulin concentration and glucose infusion rate time curves. From time 0 to 36 hours post dosing, tight glucose control was maintained for approximately five hours longer with Glargine 300 compared with Glargine 100.
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Shawn so certainly basal insulins are a big part of everything that we do in our use of insulin in our patients with type 2 diabetes. Some of the things to kind of think about, so certainly longer control, better control is something we're going to be, you know, excited about. You may one concern, and there also is a U500 insulin that is out on the market is just kind of look alike, sound alike drugs. You know, if people are used to giving, you know, x amount that this is, if it's three times as concentrated, you're going to give people three times as less volume. So I think this product was FDA approved a couple weeks ago and hopefully the manufacturers have kind of built in some things that are unique to this system so there won't be kind of that look alike, sound alike with other products that are similar. So someone could be giving 300 units when they think they're given 100 units, etc. So hopefully that will be worked out. But certainly for our listeners to know there is a U500 is out there and now there will be a U300 that's out there. So certainly when we're using some of these novel products, any of the folks we work with, you know, in nursing and house staff and things like that, we really might need to kind of, you know, stop for a moment and kind of talk about some of the new products and what's the benefit for them and are also some of the different things we're going to have to do for administration.
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Our next article is going to be from Diabetes Spectrum, the winter edition on effectiveness and safety of high intensity interval training in patients with type 2 diabetes. Low cardiorespiratory fitness is a well known risk factor for a lot of chronic diseases, including including diabetes. Low respiratory fitness is a major predictor of mortality as well. In diabetes, a single bout of exercise increases insulin sensitivity for up to 48 hours into recovery and is accompanied by improved glycemic control in individuals with type 2 diabetes. The intensity, duration and type of exercise likely play an important factor in the effects of exercise. This review discussed recent evidence on something that's become very popular in exercise circles, which is high intensity interval training. Basically, high intensity interval training is taking short periods of about a minute of almost maximum exercise and alternating that with usually longer periods of average intensity exercise. The overriding goal here is to try to get a better workout, essentially better outcomes in less time. That has a lot of promise in a world where we're all over busy and don't have enough time to exercise but want to gain the benefits of exercise. There have been numerous high intensity exercise training protocols that have been tested in individuals with coronary disease, heart failure, chronic obstructive pulmonary disease and metabolic syndrome that have all shown pretty good effects when compared to energy expenditure matched moderate intensity walking at approximately 65% of maximal aerobic capacity. High intensity interval training has generally been found to offer superior cardiovascular benefits. A recent meta analysis of studies in participants with lifestyle related metabolic diseases reported that the increase in cardiorespiratory fitness after high intensity interval training is approximately double the increase after moderate intensity continuous training. Studies directly comparing high intensity interval training to traditional moderate intensity exercise in people with type 2 diabetes are less common. There was a recent study done that reported superior effects of high intensity interval training involving free living interval walking compared to moderate intensity continuous walking in patients with type 2 diabetes. After training, the interval walking group had better improve. Improvements in body composition, aerobic fitness and glucose control is assessed by continuous glucose monitoring. One low volume high intensity protocol that has shown preliminary effectiveness in patients with type 2 diabetes involves 101 minute vigorous intensity efforts at 90% of maximal aerobic capacity interdispersed with 1 minute rest periods. As little as two weeks of training in this manner three times per week was effective at reducing 24 hour mean blood glucose in previously inactive participants with type 2 diabetes. In another study they assessed an even lower volume high intensity interval training protocol involving four 30 second episodes at 100% of maximal aerobic capacity with four minute rest periods in nine patients with type 2 diabetes with blood glucose was reduced immediately after each session, although there was no difference in fasting insulin or glucose after six sessions in two weeks. However, the authors noted that six of the nine participants did see improvements in insulin resistance. Longer term studies Low volume high intensity interval training investigated 12 weeks versus continuous exercise in 43 patients with type 2 diabetes and basically showed that both low volume high intensity training and continuous training improved body fat, mass, cardiorespiratory fitness, endothelial function and fasting glucose. However, the benefits were greater in the high intensity interval training group. Basically what the authors conclude is that high intensity interval training can be prescribed fairly easily. Patients can be advised to either assess whether they're achieving high intensity by how much effort they're putting in or by calculating the percent of maximal heart rate that they're achieving. Remember, maximal heart rate is 220 minus your age and high intensity should be achieving approximately 85% of maximal heart rate and that there's mounting evidence supporting the potential cardiometop benefits of high intensity interval training for patients with type 2 diabetes.
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Our next article is from Clinical Diabetes and its Cutaneous Manifestations of Diabetes. This particular article the publishers have unlocked so you can go to go and see this article and certainly having a someone talk on a podcast talk about a dermatology article is a little bit difficult. But I think this is really a wonderful article. I want to hit some of the high points but I really think it's a great article for clinicians to go and look at some of these things that they commonly see in their office and might not know what they are. So overall looking at diabetes in general affects about 8.3% of the population. And some studies have found when they examined a diabetic population, close to 80% of those folks have some skin manifestation, the most common being xerosis or dry skin, as well as cutaneous infections, maybe intertrigo and then some various inflammatory skin disease. I want to hit on a few of the high points. So acanthosis nigricans is certainly something we're going to think about when we're going to take a board exam or see a patient, which is going to be that hyperpigmented velvety area that's thickening of the skin folds often on the neck, under the arms. So certainly there are several types of acanthosis nigricans, but for the most part they are all going to find themselves associated with either diabetes or something in the spectrum of metabolic disorders. In children, the link is less close, but still up to 25% of children can have acanthosis nigra gains for treatment. If someone is especially bothered, we could use some of our topical or systemic retinoids like a retin, a type product, might help to decrease some of the hyperpigmentation. Another thing to think about is skin tags. You know, we see patients who come in with skin tags and you know, doc, why do I have skin tags? And you kind of shrug your shoulders and say, you know, goes along with, you know, age or whatever. But skin tags can be associated with acanthosis nigricans, which would also associate it also being associated with some disorder in how our body is dealing with sugar. So one of the things when we see people who have lots of skin tags, I think it would make some sense. We certainly know how to take care of skin tags, but I think it would make sure that we kind of make sure that we've screened folks. Another condition is diabetic dermopathy. And a study from Sweden found that diabetic dermopathy affects 33% of folks with type 1 diabetes and 39% of folks with type 2 diabetes. But for the type 2 diabetics, it's going to be the folks who have poor glycemic control. Another study found that diabetic dermopathy was only present in 0.2% of folks who had good control of their diabetes. And that is going to be the presence on the anterior shin of some kind of light salmon colored nodules, papules, macules, on the pre tibial area, which can be a sign of insulin resistance. So something that we might see that I think we probably brush off as something else, eruptive xanthomas. And I think eruptive xanthomas can be associated with hypertriglyceridemia and certainly elevated blood sugar travels with hypertriglyceridemia. It is part of a deficiency in lipoprotein lipase and people can have basically almost these cholesterol laden papules that will be on the extensor surfaces. And certainly when we get people's triglycerides down, we get their metabolic house in order that can improve. They also talked about rubiosis facie which is a kind of a redness of the face that goes along with diabetes and that is actually seen to 3 to 5% of folks with diabetes, which I think perhaps we write off as being rosacea or something else. So certainly some other article, a lot of other dermatologic disorders to talk about, but I think really a great read for you to kind of check out to see the articles or some of the pictures. Our next article is from Diabetes Care and it looked at saxagliptin and cardiovascular outcomes in patients with type 2 diabetes and moderate or severe renal impairment. And this was the SAVR TIMI53 trial. In this particular study, patient with type 2 diabetes who are at risk for cardiovascular events were stratified as having normal or mildly impaired renal function, moderate renal function or severe renal function. So the moderate renal function were estimated GFRs between 30 and 50 and the severe were estimated GFRs less than 30. They were randomized to receive saxagliptin or placebo. The primary endpoint was cardiovascular death, myocardial infarction or ischemic stroke. After a median duration of 2 years. Saxagliptin neither increased nor decreased the risk of the primary and secondary composite endpoints complex with placebo irrespective of renal function. The relative risk for hospitalization for heart failure with saxagliptin was similar in patients with an estimated GFR greater than 50, estimated GFR between 30 and 54 and in patients with an estimated GFR that was less than 30. Patients with renal impairment achieved reductions of microabinoria with soft saxagliptin that were similar to those of the overall trial population.
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You know John, this article is reassuring that saxagliptin shows no safety signals, no concerns with regard to increasing cardiovascular outcomes since about five or seven years ago when the concerns came out about rosiglitazone improving A1Cs but having adverse cardiovascular outcomes. Part of the concerns for any new medicine coming to market, and I believe actually an FDA requirement, is that post launch that companies also provide and record cardiovascular safety. So this really is reassuring that both in patients as a whole, in patients with normal renal function, patients with mild, moderate impaired renal function, there are no safety signals. So we can take a lot of reassurance from that. There is an increase in hospitalizations for CHF that was noted. So that's something to be aware of. And there's no difference in patients regarding degree of renal dysfunction. So again, in general, very large study, very reassuring. Our next article is from Diabetes Care on tight glycemic control and use of hypoglycemic medicines in older Veterans with type 2 diabetes and comorbidities conditions. This retrospective cohort study of the National Veterans Affair Administrative Clinical Database and Medicare claims for years 2008 to 2009 included over 15,000 veterans aged greater than 65 with type 2 diabetes and dementia who were prescribed antidiabetic medicines. 52% of these patients had tight glycemic control with A1Cs less than 7. Among tightly controlled patients, 75% use sulfonylurea medications and or insulin.
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John so I think this is a recurrent topic that we talk about. So certainly for younger people who are going to be on the planet a long, long time, tight control makes lots and lots of sense in preventing a lot of the more troubling long term outcomes with diabetes. So people who have a moderate dementia, you know, they already have a fatal illness and I think having tight glycemic control does not make, you know, a whole lot of sense. And also if you have a confused older person who's not acting right, are they not acting right because they're this is something related to their dementia or is this because their sugar is 50? I think it is labor intensive. And the classic book we talk about is the 36 hour day and taking care of someone with dementia. I think for our patients, you know, we need to make it a little bit easier for caregivers and I think we need to look at, you know, what is our A1C goal. And I certainly think someone who has, you know, a severe cognitive impairment in an older person probably that, you know, that seven and a half to nine is probably a very reasonable spot to keep someone's blood sugars. And I also think we need to think about, you know, what agents are we putting someone on, we're putting them at risk for hypoglycemia.
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For more information and links to the articles that we discussed in this issue, just go to www.www.diabetesjournals.org until next week. Keep listening and keep learning.
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Sa.