Device implantation could be the future in T2DM and weight loss…
Weight gain is often a side effect of several different oral antidiabetic drugs (OADs), such as sulfonylureas and thiazolidinedion, along with insulin. Lifestyle modification and weight loss is always recommended in T2DM, but we all know it takes great effort and depends on the individual patient to accomplish the task. Surgical procedures such as bariatric surgery and gastric electric stimulation (GES) can help reduce food intake and induce weight loss.
Tantalus II™ (Diamond) is a GES device that has been shown to be effective in improving glycemic control and weight loss in T2DM without OADs; however, it has never been directly compared to insulin therapy after OAD failure. Hong Kong researchers compared the effects of gastric contraction modulation (GCM) to insulin therapy in T2DM Chinese patients, ages 18-60 years old, who had failed OADs and who were also unsuccessful with standard lifestyle modifications. Other inclusion criteria included: minimum of 2 year duration of T2DM, BMI between 27.5-40 kg/m2, HbA1c >7.5%, and treated with 2 or more OADs. Patients were divided into two groups: a GCM implantation with Tantalus II group (GCM, N=8) and insulin therapy group (INS, N=8 (matched out of 11)). Outcome measures were: body weight (BW), BMI, waist circumference (WC), and body fat percentage. These outcomes were assessed at baseline, 3-, 6-, 9-, and 12-months. HbA1c, lipid panel, and 24-hour blood pressure were also assessed. X2, Fischer’s exact test, Mann-Whitney U test, Wilcoxon signed-rank test rANOVA, Greenhouse-Geisser, and Huynh-Feldt test were used where appropriate for the statistical analyses.
Body composition results showed a significant weight loss and weight circumference reduction with the GCM group, while the INS group showed increases in body weight and percentage change in body weight. Patients in the GCM showed greater decrease from baseline in HbA1c compared to the insulin group:
The INS group dose of insulin was increased through the study from 8.3±0.6 units/day to 28.0±6.8 units/day by 12 months, and 2 patients from the GCM group required rescue insulin at 12 months.
Insulin therapy is usually the standard of therapy following failure of OADs; however insulin often cause T2DM patients to gain weight. Several GES implants are already available for use as an alternative therapy to insulin use. This study showed that, along with significant weight loss, HbA1c could also be reduced with GES implantations. Even though GCM therapy was shown to be safe and effective, the sample size in this study was small. This study also lacks long-term data. Body weight and HbA1c difference from baseline and 12 months was less than the difference between baseline and 6 months; further studies should be done to see if the trend continues with long term use, indicating that GES is not an effective therapy in T2DM in the long run.
- GES could potentially be an alternative to lifestyle modification and insulin therapy.
- Compared to insulin, GES showed a greater reduction in body weight and HbA1c.
- Further studies will be needed to show its long-term chronic use as an alternative to insulin therapy.
SK Wong. Diabetes Technology & Therapeutics, Vol 17, #4, 2015; DOI: 10.1089/dia.2014.0234