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Study for Pre-Surgical Weight Loss in Type II Diabetes Patients

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ClinicalTrials.gov Identifier: NCT00791128
Recruitment Status : Completed
First Posted : November 14, 2008
Results First Posted : December 28, 2016
Last Update Posted : June 1, 2017
Sponsor:
Information provided by (Responsible Party):
GI Dynamics

Brief Summary:
The purpose of this study is to determine whether the GI Sleeve is safe and effective in treating Type II diabetes patients

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Obesity Device: GI Liner Phase 2

Detailed Description:
Patients with obesity are at significantly greater risk of developing complications such as pulmonary dysfunction, diabetes, hypertension, and other co-morbid risks. NIH panel recommendations state that even a 10% short-weight loss would greatly reduce these risks. GI Dynamics' GI Sleeve represents a viable alternative to other short-term pre-surgical weight loss methods. GI Sleeve is a device that can be implanted and removed through minimal invasive endoscopic techniques. This endoscopic procedure brings potential benefits to patients in that it is minimally invasive, efficacious, and allows patients to recover faster with less morbidity and mortality.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Single-Center, Prospective, Open Label Study of Safety and Efficacy, of the GI Sleeve for Pre-Surgical Weight Loss, in Type II Diabetes Patients (Cohort 06-6B Only)
Study Start Date : October 2008
Actual Primary Completion Date : March 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: EndoBarrier GI Liner
22 patients were implanted with the GI Liner for a 52-week duration. Assessments were performed during the 6 months post-explant period.
Device: GI Liner
Medical device placed endoscopically in the duodenum, nutritional counseling
Other Name: GI Endobarrier Liner



Primary Outcome Measures :
  1. % of Excess Weight Loss (EWL) [ Time Frame: 12 months ]

    Percent excess weight loss (EWL) was calculated using Body Mass Index (BMI25) method: BMI25=ideal weight in kg/(height in meters)2 Ideal weight in kg = 25 x (Height in meters2) Baseline Excess weight = total weight - ideal weight

    % EWL = (baseline excess weight - weight loss) x 100



Secondary Outcome Measures :
  1. HbA1c Values at 12 Months [ Time Frame: 12 months ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 to 65
  • BMI 40 to 60
  • Type II Diabetes
  • Candidates for bariatric surgery

Exclusion Criteria:

Patients with

  • hepatitis B or C
  • gastroesophageal reflux disease (GERD)
  • HIV Positive diagnosis
  • pancreatitis
  • conditions of gastrointestinal tract, such as ulcers or Crohn's
  • an infection or who are H. Pylori positive

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00791128


Locations
Brazil
Dr. Eduardo Guimaraes Hourneauz de Moura
Sao Paulo, SP, Brazil, 05493900
Sponsors and Collaborators
GI Dynamics
Investigators
Principal Investigator: Eduardo Guimaraes Hourneaux de Moura, MD Hospital das Clinicas, Sao Paulo

Publications of Results:
Responsible Party: GI Dynamics
ClinicalTrials.gov Identifier: NCT00791128     History of Changes
Other Study ID Numbers: 06-6
First Posted: November 14, 2008    Key Record Dates
Results First Posted: December 28, 2016
Last Update Posted: June 1, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by GI Dynamics:
Type 2 Diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Weight Loss
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Body Weight Changes
Body Weight
Signs and Symptoms