EASD 2018: RISE Study Suggests Gastric Banding Slows Progression of Type 2 Diabetes
But 2-year follow-up is too early to draw firm conclusions
October 3, 2018—Berlin, Germany—Early metabolic changes following gastric banding suggest it might slow the progression of disease in patients with prediabetes or early type 2 diabetes as much as metformin, according to the results of the latest Restoring Insulin Secretion (RISE) Consortium study, presented at the 54th Annual Meeting of the European Association for the Study of Diabetes, taking place here from Oct 1 – 5, 2018.
The RISE consortium is testing various interventions designed to preserve or improve beta cell function in prediabetes or early type 2 diabetes.
For this particular study, presented by Thomas Buchanan, MD, with the University of Southern California in Los Angeles, 88 prescreened patients with prediabetes or early type 2 diabetes were randomized to receive metformin or gastric banding. Of these, data on 34 patients in the metformin arm and 36 in the gastric banding arm were available for follow-up analysis.
The average age of patients was approximately 50 years, body mass index was 35 kg/m2, and approximately 80% were female. Racial distribution included approximately 47% Hispanic patients, 25% white, 20% black, and 7% Asian. The average fasting glucose was 6.2 mmol/L, and the average HbA1c was 41 mmol/mol. These baseline characteristics were similar in both groups of patients with the exception of a slightly older average age in the metformin group.
Overall, 50% of patients in the metformin group had impaired glucose tolerance and 50% had type 2 diabetes at baseline. In the gastric banding group, 58% had impaired glucose tolerance and 42% had diabetes. There was no statistical difference between the two groups with respect to these values.
The primary outcomes of the trial were two measures of beta cell response: steady-state C-peptide (SSCP) and acute c-peptide response at maximal glycemia (ACPRmax). These were adjusted for insulin sensitivity to find the relationship between the glucose infusion rate and plasma insulin levels at steady state.
Both groups of patients lost and maintained weight loss during the study period, but weight loss was significantly greater in the gastric banding group (-1.kg vs -10.6 kg; P < .01). Both groups of patients also had increases in HDL cholesterol, but gastric banding was found to be better than metformin at lowering very low density lipoprotein cholesterol, total triglycerides, and serum alanine aminotransferase.
Beta cell response fell in a pattern that maintained relatively stable compensation for insulin resistance. Acute beta cell compensation to glucose improved significantly with gastric banding, while beta cell compensation at maximal stimulation fell significantly with metformin.
Glucose levels improved only slightly. There were no differences between the two groups of patients with respect to fasting glucose or 2-hour glucose values at the end of the study. HbA1c had significantly dropped in the gastric banding but not the metformin group at 24 months, compared to baseline.
There was an approximate 50% improvement in insulin sensitivity at 1 year that attenuated at 2 years in both groups. At 24 months, 22% of patients in the gastric banding group had normal glucose tolerance, 45% had impaired glucose tolerance, and 33% had diabetes. In the metformin group, 15% had normal glucose tolerance, 44% had impaired glucose tolerance, and 41% were diabetic.
“There was a slight but highly significant improvement in fasting glucose and an improvement in other aspects of metabolism. The fats in the blood went down, for instance,” Roy Taylor, MD, with Newcastle University in Newcastle Upon Tyne in the United Kingdom, told Elsevier’s PracticeUpdate. Dr. Taylor moderated the session that included presentation of the RISE results.
“These are very good prognostic indicators, but the 2-year timespan of the study was too early to be able to see what they really wanted; in other words, does this affect insulin secretion?” he noted. “At the time, the insulin secretion is pretty good. The pancreas is working slight overtime, but it can still respond to meals. The fact that they saw no change in that particular parameter with the weight loss should come as no surprise to anyone because, in fact, if we do nothing, it would hardly change over that time.”
“It’s all good news,” concluded Dr. Taylor. “Weight loss will produce changes to suggest that patients have been taken off the path to diabetes, but it’s just not long enough to see the effect they were trying to measure.”
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