A Study of the GI Sleeve for the Treatment of Type 2 Diabetes
|ClinicalTrials.gov Identifier: NCT02709577|
Recruitment Status : Completed
First Posted : March 16, 2016
Results First Posted : December 28, 2016
Last Update Posted : December 28, 2016
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes||Device: EndoBarrier Gastrointestinal Liner Other: Sham: endoscopy and standard of care||Phase 1 Phase 2|
The study was designed as a randomized, single blind, sham controlled, pilot efficacy study of subjects with Type 2 diabetes enrolled at 2 centers in Santiago, Chile. Subjects were enrolled at a 2:1 ratio (EndoBarrier to sham). Following implantation or sham procedure, subjects were treated for 24 weeks or 52 weeks. Following explant, subjects were followed for an additional 8-12 weeks.
Subject evaluations included measurements of HbA1c, glucose, insulin, weight, changes in diabetic medications, and meal tolerance tests. Safety was monitored through the collection of clinical labs, physical assessments, endoscopy and adverse events.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Pilot Feasibility Sham Controlled Study of the GI Sleeve for the Treatment of Type 2 Diabetes|
|Study Start Date :||January 2007|
|Actual Primary Completion Date :||January 2009|
|Actual Study Completion Date :||January 2009|
Experimental: EndoBarrier Gastrointestinal Liner
Subjects randomized and implanted with the EndoBarrier Gastrointestinal liner; subjects will be implanted for 24 weeks to 52 weeks and evaluated for study endpoints.
Device: EndoBarrier Gastrointestinal Liner
The EndoBarrier is a single use, implant consisting of a tube of composite material which is placed in the proximal section of the duodenum. The implant is fixed in place with the aid of a metal anchor. The device is delivered via an endoscope. The implant facilitates the passage of food from the stomach through the tube to the proximal section of the jejunum.
Other Name: GI Sleeve
Experimental: Sham: endoscopy and standard of care
Subjects randomized to sham arm received an upper GI examination and were evaluated for study endpoints.
Other: Sham: endoscopy and standard of care
Sham subjects had an endoscopic procedure and then received standard of care treatment of their diabetes
Other Name: Control
- Change in HbA1c Values From Baseline Measurement [ Time Frame: Baseline to 24 weeks or 52 weeks ]
Cohort A: Assessment of improvement in the glycemic control defined as a change in HbA1c values from baseline.
Cohort B. Assessment of improvement in glycemic control defined as a change in HbA1c values of at least 0.5% from baseline.
- Absolute Weight Change [ Time Frame: 24 weeks or 52 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02709577
|Principal Investigator:||Leonardo Rodriguez Grunert, MD||Hospital Dipreca|