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/m² (± 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 ≤ 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.