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Trial record 7 of 32 for:    gi dynamics

A Study of the GI Sleeve for the Treatment of Type 2 Diabetes

This study has been completed.
Sponsor:
Collaborator:
Hospital Dipreca
Information provided by (Responsible Party):
GI Dynamics
ClinicalTrials.gov Identifier:
NCT02709577
First received: March 11, 2016
Last updated: November 1, 2016
Last verified: November 2016
  Purpose
The purpose of the study was to evaluate the safety and efficacy of the EndoBarrier Gastrointestinal Liner compared to sham control in subjects with Type 2 diabetes.

Condition Intervention Phase
Type 2 Diabetes
Device: EndoBarrier Gastrointestinal Liner
Other: Sham: endoscopy and standard of care
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Pilot Feasibility Sham Controlled Study of the GI Sleeve for the Treatment of Type 2 Diabetes

Further study details as provided by GI Dynamics:

Primary Outcome Measures:
  • Change in HbA1c Values From Baseline Measurement [ Time Frame: Baseline to 24 weeks or 52 weeks ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • Absolute Weight Change [ Time Frame: 24 weeks or 52 weeks ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: January 2007
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Genders Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 18 years and < 55 years - Male or Female
  • Patients with type 2 diabetes, treated for 10 years or less
  • HbA1c level ≥ 7.0 and ≤ 10.0%
  • Fasting glucose ≤ 240 mg/dl
  • Patients taking metformin, sulfonylureas or thiazolidinediones (TZDs), either alone or in combination
  • BMI > 30 and <50
  • Patients willing to comply with study requirements
  • Patients who have signed an informed consent form
  • Women who are post-menopausal, surgically sterile, or on oral contraceptives for at least three months and who do not plan on becoming pregnant during the course of the study.

Exclusion Criteria:

  • Patients taking oral medications to control their diabetes other than sulfonylureas, metformin or thiazolidinediones
  • Patients diagnosed with type 1 diabetes mellitus or had a history of ketoacidosis
  • Patients requiring insulin
  • Patients with lab evidence of probable insulin production failure (fasting C peptide serum level < 1ng/ml)
  • Patients with a weight loss of > 10 lbs within the three months of screening
  • Patients requiring prescription anticoagulation therapy
  • Patients with iron deficiency and iron deficiency anemia
  • Patients with a history of abnormal pathologies of the GI tract
  • Patients with known gallstones or kidney stones prior to implant
  • Known infection at the time of implant
  • Severe coagulopathy, upper gastro-intestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasia
  • Pregnant or has the intention of becoming pregnant in the next 12 months
  • Patients with a history of active kidney stones
  • Mentally retarded or emotionally unstable, or exhibits psychological characteristics which, in the opinion of the investigator, makes the subject a poor candidate for device placement or clinical trial
  • Previous GI surgery that could affect the ability to place the sleeve or the function of the implant
  • Patients unable to discontinue NSAIDs (non-steroidal anti-inflammatory drugs) during the implant period
  • H. pylori positive patients (Note: patients may be enrolled if they had a prior history and were successfully treated)
  • Patients receiving weight loss medications such as Meridia and Xenical
  • Family or patient history of a known diagnosis or pre-existing symptom of systemic lupus erythematous, scleroderma or other autoimmune connective tissue disorder
  • Patients with Gastrointestinal Reflux Disease (GERD)
  • Participating in another ongoing investigational clinical trial
  • Patients taking corticosteroids or drugs known to affect gastrointestinal motility (such as reglan)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02709577

Sponsors and Collaborators
GI Dynamics
Hospital Dipreca
Investigators
Principal Investigator: Leonardo Rodriguez Grunert, MD Hospital Dipreca
  More Information

Responsible Party: GI Dynamics
ClinicalTrials.gov Identifier: NCT02709577     History of Changes
Other Study ID Numbers: 06-5 
Study First Received: March 11, 2016
Results First Received: September 13, 2016
Last Updated: November 1, 2016
Health Authority: Chile: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: Yes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on January 14, 2017