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EndoBarrier in Obese Subjects With Type 2 Diabetes Mellitus

NCT02769728 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2024-04-08

Study results available
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Summary

The aim of the study is to explore short and longer-term effects of the Endobarrier™ implantation on insulin resistance and beta-cell function assessed by repeated Botnia clamps. In addition changes in gut peptides and gut permeability after implantation of a removable duodeno-jejunal bypass device to induce diabetes remission in obese subjects with sub-optimally controlled type 2 diabetes mellitus will be determined. Further changes in body weight and body composition, the change in global cardiovascular risk from baseline to 12 months, estimated using the UKPDS risk engine will be recorded.

Conditions

Interventions

DEVICE

EndoBarrier

implantation of a duodeno-jejunal bypass liner for weight reduction in obese subjects with type 2 diabetes mellitus

Sponsors & Collaborators

  • Medical University of Graz

    lead OTHER

Principal Investigators

  • Harald Sourij, MD · Medical University of Graz, Auenbruggerplatz 15

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2018-12-01
Completion
2019-01-31

Countries

  • Austria

Study Locations

More Related Trials

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 NCT02769728 on ClinicalTrials.gov