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

• 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: GI Dynamics
• Information provided by (Responsible Party): GI Dynamics

Tracking Information

• First Submitted Date: November 12, 2008
• First Posted Date: November 14, 2008
• Results First Submitted Date: November 1, 2016
• Results First Posted Date: December 28, 2016
• Last Update Posted Date: June 1, 2017
• Study Start Date: October 2008
• Actual Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Not Provided
• Current Secondary Outcome Measures (submitted: April 12, 2017): HbA1c Values at 12 Months [ Time Frame: 12 months ]
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Study for Pre-Surgical Weight Loss in Type II Diabetes Patients
• 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)
• 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Type 2 Diabetes
• Obesity

Intervention

Device: GI Liner

Medical device placed endoscopically in the duodenum, nutritional counseling

Other Name: GI Endobarrier Liner

Study Arms

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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 1, 2016): 22
• Original Enrollment: Not Provided
• Actual Study Completion Date: December 2010
• Actual Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Brazil

Administrative Information

• NCT Number: NCT00791128
• Other Study ID Numbers: 06-6
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Responsible Party: GI Dynamics
• Study Sponsor: GI Dynamics
• Collaborators: Not Provided

Investigators

• Principal Investigator: Eduardo Guimaraes Hourneaux de Moura, MD; Hospital das Clinicas, Sao Paulo

• PRS Account: GI Dynamics
• Verification Date: April 2017