Metabolic Improvement in Type 2 Diabetes

Ricardo Cohen1, Chris Sorli2, Jose Luis Correa1, Tarissa Petry1, Joao Salles1, Carlos Schiavon1, Bruno Martins1, Manoel Galvao3, Paolo Sakai1 [1 Hospital Alemão Oswaldo Cruz, São Paulo, Brazil 2 The Billings Clinic, Billings, Montana 3Gastro Obeso Center, Gastrointestinal Surgery Department, São Paulo, Brazil]

Background:

The duodenal-jejunal bypass liner (DJBL, GI Dynamics, Inc., Lexington, MA) is an endoscopic implant that mimics the intestinal bypass component of the Roux-en-Y gastric bypass. The DJBL has been shown to result in significant improvement in glycemic control in obese subjects with severe obesity and type 2 diabetes (T2D). This report describes the first use of the DJBL in lower BMI subjects with T2D.

Methods:

Twenty-three subjects with T2D treated with oral hypoglycemic agents, baseline BMI between 23-36 kg/m2 were enrolled. Twenty of 23 subjects were successfully implanted with the DJBL. Three could not due to unfavorable anatomy. Four subjects underwent early endoscopic removal due to device movement (2), abdominal pain (1) and PI request (1). Follow-up included monthly determinations of HbA1c, fasting plasma glucose (FPG), lipids and %TBW.

Results:

Baseline data was; HbA1c (8.7±0.20%), FPG (197.5±16.8 mg/dl), LDL (137.8±13.1 mg/dl), triglycerides (226.1±35.5 mg/dl) and BMI (30.2±0.83 kg/m2) (Mean±SE). The DJBL remained in place for one year in 13/17 subjects (76.4%) with 3 subjects ongoing. At 1 year, change from baseline was: HbA1c (-1.3±0.37%), FPG (-4.1±20.7 mg/dl), LDL (-25.6±7.0 mg/dl), triglycerides (-42.5±17.3 mg/dl) and %TBWL (8.4±1.7%) per protocol analysis. Three and 12 months post-implant, 63.2% (12/19) and 61.5 % (8/13) of subjects exhibited HbA1c < 7.0%, respectively.

Conclusions:

DJBL treatment for one year in T2D patients with low BMIs resulted in substantial improvement in HbA1c, FPG and lipid parameters. The magnitude of the observed glycemic and lipid improvements is similar to those previously reported in severely obese T2D subjects.