A pilot study to compare meal-triggered gastric electrical stimulation and insulin treatment in Chinese obese type 2 diabetes

Abstract

Background: Gastrointestinal electromodulation therapy is a novel alternative for achieving diabetes control without traditional bariatric surgery. We compared the efficacy of a meal-initiated implantable gastric contractility modulation (GCM) device with that of insulin therapy in obese Chinese type 2 diabetes (T2D) patients, for whom oral antidiabetes drugs (OADs) had failed.

Patients and methods: Sixteen obese (body mass index, 27.5-40.0 kg/m(2)) T2D patients with a glycated hemoglobin (HbA1c) level of >7.5% on maximal doses of two or more OADs were offered either insulin therapy (n=8) or laparoscopic implantation of a GCM (n=8). We compared changes in body weight, waist circumference (WC), and HbA1c level 1 year after surgery.

Results: The GCM and insulin groups had similar baseline body weight and HbA1c. At 12 months, body weight (-3.2±5.2 kg, P=0.043) and WC (-3.8±4.5 cm, P=0.021) fell in the GCM group but not in the insulin group (P<0.05 for between-group difference). At 6 and 12 months, the HbA1c level fell by 1.6±1.1% and 0.9±1.6% (P=0.011), compared with 0.6±0.3% and 0.6±0.3% (P=0.08) for the insulin group (P=0.15 for between-group difference). The mean 24-h systolic blood pressure (BP) fell by 4.5±1.0 mm Hg in the GCM group (P=0.017) but not in the insulin group. The GCM group required fewer antidiabetes medications (P<0.05) and BP-lowering drugs (P<0.05) than the insulin group. A subgroup analysis showed that patients with a triglyceride level of <1.7 mmol/L had a tendency toward a lower HbA1c level (P=0.090) compared with the controls.

Conclusions: In obese T2D patients for whom OADs had failed, GCM implantation was a well-tolerated alternative to insulin therapy, with a low triglyceride level as a possible predictor for glycemic response.

Trial registration: ClinicalTrials.gov NCT00975533.

Figures

FIG. 1.

Changes in body composition and glycated hemoglobin (HbA1c) in obese Chinese type 2 diabetes patients before and after treatment with supplementary insulin (open squares) or a gastric contractility modulator (TANTALUS II) (solid circles): (A) body weight, (B) waist circumference (WC), (C) body fat percentage, and (D) HbA1c. The P value represents the estimated difference between the two groups by repeated-measures analysis of variance (rANOVA).

FIG. 2.

Changes in body weight and glycated hemoglobin (HbA1c) in obese Chinese type 2 diabetes patients implanted with a gastric contractility modulator (TANTALUS II) (solid circles) stratified by baseline plasma triglyceride (TG), compared with the insulin treatment group (open squares): (1a and 1b) body weight and (2a and 2b) HbA1c between the insulin group and (1a and 2a) the low TG TANTALUS group or (1b and 2b) the high TG TANTALUS group. The P value represents the estimated difference by repeated-measures analysis of variance (rANOVA).