Context: The duodenal-jejunal bypass liner (DJBL) is a device that mimics the intestinal portion of gastric bypass surgery and has been shown to improve glucose metabolism rapidly in obese subjects with type 2 diabetes (T2DM).
Objective: To assess the safety of the DJBL and to evaluate its potential to affect glycemic control beneficially in subjects with T2DM who were not morbidly obese.
Patients and design: Adult men and women with T2DM of ≤ 10 years' duration with hemoglobin A1c (HbA1c) ≥ 7.5% and ≤ 10% and having a body mass index ≥ 26 to ≤ 50 kg/m(2) were enrolled in this prospective, 52-week, single-center, open-label clinical study.
Main outcome measures: Adverse events and changes in body weight, fasting plasma glucose (FPG) levels, and HbA1c levels.
Results: Sixteen of 20 subjects implanted with the DJBL completed the 1-year study (mean body mass index = 30.0 ± 3.6, mean ± SD). Gastrointestinal disorders were reported by 13 subjects, and metabolic or nutritional disorders occurred in 14 subjects. FPG levels dropped from 207 ± 61 mg/dL at baseline to 139 ± 37 mg/dL at 1 week and remained low throughout the study. Mean body weight also declined, but the change in body weight was not significantly associated with change in FPG at 52 weeks. HbA1c declined from 8.7 ± 0.9% at baseline to 7.5 ± 1.6% at week 52.
Conclusions: The improvements in glycemic status were observed at 1 year in moderately obese subjects with T2DM, suggesting that the DJBL may represent an effective adjuvant to standard medical therapy of T2DM in this population.