Metabolic Effects of Duodenal Jejunal Bypass Liner for the Treatment of Adipose Patients With Type 2 Diabetes Mellitus (DJBL-T2DM)

NCT02800668 COMPLETED

Implantation of a duodenal-jejunal endoluminal bypass liner (DJBL) has shown to induce weight loss and to improve metabolic parameters. DJBL is a reversible endoduodenal sleeve mimicking biliodigestive digestion while lacking risks and limitations of bariatric surgery. Effects on metabolic control, body mass parameters, appetite regulation, glucose tolerance, organ health, and lipid profile were determined in 16 morbidly overweight patients with type 2 diabetes mellitus. In addition, relevant hormones (Leptin, ghrelin, gastric inhibitory peptide, glucagon-like peptide 1, and insulin) were measured by enzyme-linked immunosorbent assay (ELISA) and chemiluminescent microparticle immunoassay (CMIA) at 0, 1 and 32, and 52 weeks post-implant following a mixed meal tolerance test, which was applied for diagnostic purposes only.

Details

Lead sponsor	Ruhr University of Bochum
Status	COMPLETED
Enrolment	19
Start date	2011-10
Completion	2015-06

Conditions

• Type 2 Diabetes Mellitus
• Obesity

Interventions

• DJBL (Duodenal jejunal bypass liner, EndoBarrier)

Primary outcomes

• weight loss in kg — 12 months
  weight loss defined as excess weight loss

Countries

Germany