ABSTRACT
BACKGROUND: The purpose of this study was to evaluate the efficacy and safety of Endobarrier® in grade 1 obese T2DM patients with poor metabolic control and the role of gastro-intestinal hormone changes on the metabolic outcomes. METHODS: Twenty-one patients aged 54.1 ± 9.5 years, diabetes duration 14.8 ± 8.5 years, BMI 33.4 ± 1.9 kg/m2, and HbA1c 9.1 ± 1.3 %, under insulin therapy, were implanted with Endobarrier®. Fasting concentrations of PYY, ghrelin and glucagon, and AUC for GLP-1 after a standard meal test were determined prior to and at months 1 and 12 after implantation. RESULTS: Patients lost 14.9 ± 5.7 % of their total body weight. HbA1c decreased 1.3 % in the first month, but at the end of the study, the reduction was 0.6 %. HbA1c ≤ 7 % was achieved in 26.3 % of patients. No differences in GLP-1 AUC values were found before and after implant. Fasting plasma ghrelin and PYY concentrations increased from month 1 to 12. Conversely, fasting plasma glucagon concentrations decreased at month 1 and increased thereafter. Weight (ß 0.152) and HbA1c decrease at month 1 (ß 0.176) were the only variables predictive of HbA1c values at 12 months (adjusted R 2 for the model 0.693, p = 0.001). Minor adverse events occurred in 14 % of patients and major events in 9.5 %. CONCLUSIONS: Endobarrier® in T2DM patients with grade I obesity and poor metabolic control is associated with significant weight decrease and moderate reduction in HbA1c at month 12. Our data do not support a role for GLP-1 in the metabolic improvement in this subset of patients.
