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Metabolic Effects of Duodenal Jejunal Bypass Liner for Type 2 Diabetes Mellitus

NCT02800668 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 19

Last updated 2024-09-19

No results posted yet for this study

Summary

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.

Conditions

Interventions

DEVICE

DJBL (Duodenal jejunal bypass liner, EndoBarrier)

Implantation of EndoBarrier after medical and patient's decision, Duration of treatment 12 months in maximum, follow up for 4 weeks after Explantation, follow up during treatment by physical examination, ECG control, sampling and analysis of blood parameters, mixed meal tolerance tests only for diagnostic purposes to assess gut hormonal changes and metabolic parameters

Sponsors & Collaborators

  • Ruhr University of Bochum

    lead OTHER

Principal Investigators

  • Diethelm Tschoepe, Prof MD · Herz und Diabeteszentrum NRW

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2015-06-30
Completion
2015-06-30

Countries

  • Germany

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02800668 on ClinicalTrials.gov