Pilot clinical study of an endoscopic, removable duodenal-jejunal bypass liner for the treatment of type 2 diabetes

Abstract

Background: Bariatric surgery is associated with the rapid improvement of type 2 diabetes (T2DM). Here we report an exploratory trial of a completely endoscopic, removable, duodenal-jejunal bypass liner (DJBL) intended to treat T2DM.

Methods: Obese T2DM subjects were randomized to receive a DJBL (n = 12) or sham endoscopy (n = 6) in a 24-week study, extended up to 52 weeks. Measurements included weights, hemoglobin A1c (HbA(1c)), meal tolerance testing, fasting glucose, and seven-point glucose profiles. Subjects' diets were adjusted in the first 2 weeks to obtain similar weight loss during this period.

Results: Subjects had baseline HbA(1c) of 9.1 +/- 1.7% and body mass index of 38.9 +/- 6.1 kg/m(2) (+/- SD). In the completer population by week 1, change in fasting glucose in the DJBL arm was -55 +/- 21 mg/dL versus +42 +/- 30 mg/dL in the sham arm (P < or = 0.05; +/- SE); the seven-point glucose profiles were reduced in the DJBL arm but not in the sham arm. Mean postprandial glucose area under the curve was reduced in the DJBL arm by 20% and increased 17% in the sham arm (P = 0.016). At week 12, HbA(1c) change was -1.3 +/- 0.9% in the DJBL arm and -0.7 +/- 0.4% in the sham arm (P > 0.05), and at 24 weeks, values were -2.4 +/- 0.7% in the DJBL arm and -0.8 +/- 0.4% in the sham arm (P > 0.05). Device migrations required endoscopic removal prior to reaching 52 weeks.

Conclusions: The DJBL rapidly normalized glycemic control in obese T2DM subjects, a promising development in the search for novel therapies less invasive than bariatric surgery.