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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE November 12, 2008
First Posted Date  ICMJE November 14, 2008
Results First Submitted Date  ICMJE November 1, 2016
Results First Posted Date  ICMJE December 28, 2016
Last Update Posted Date June 1, 2017
Study Start Date  ICMJE October 2008
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 12, 2017)
% 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
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 12, 2017)
HbA1c Values at 12 Months [ Time Frame: 12 months ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study for Pre-Surgical Weight Loss in Type II Diabetes Patients
Official Title  ICMJE 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)
Brief Summary The purpose of this study is to determine whether the GI Sleeve is safe and effective in treating Type II diabetes patients
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Type 2 Diabetes
  • Obesity
Intervention  ICMJE Device: GI Liner
Medical device placed endoscopically in the duodenum, nutritional counseling
Other Name: GI Endobarrier Liner
Study Arms  ICMJE 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.
Intervention: Device: GI Liner
Publications * de Moura EG, Martins BC, Lopes GS, Orso IR, de Oliveira SL, Galvão Neto MP, Santo MA, Sakai P, Ramos AC, Garrido Júnior AB, Mancini MC, Halpern A, Cecconello I. Metabolic improvements in obese type 2 diabetes subjects implanted for 1 year with an endoscopically deployed duodenal-jejunal bypass liner. Diabetes Technol Ther. 2012 Feb;14(2):183-9. doi: 10.1089/dia.2011.0152. Epub 2011 Sep 20.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 1, 2016)
22
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE December 2010
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00791128
Other Study ID Numbers  ICMJE 06-6
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party GI Dynamics
Study Sponsor  ICMJE GI Dynamics
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Eduardo Guimaraes Hourneaux de Moura, MD Hospital das Clinicas, Sao Paulo
PRS Account GI Dynamics
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP