Longitudinal Cohort Study Comparing 2 Surgical Techniques in Patients With Class 3 Obesity and Type 2 Diabetes
OBEDIAB
2 other identifiers
observational
56
1 country
1
Brief Summary
Wight loss surgery provides good glycemic control in type 2 diabetes. The technique of "Roux-en-Y gastric bypass" is more effective than the "Adjustable Gastric Band" on weight loss. This longitudinal cohort study will compare the effectiveness of the Roux-en-Y gastric bypass and Adjustable Gastric Banding on glycemic control in type 2 diabetes and explore the responsible mechanisms. The evaluation will be made preoperatively and 1 year later as assessed by the decline in HbA1c. An evaluation will also be carried out after a weight loss of 10% to indicate whether the observed difference is independent of weight loss.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2004
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2006
CompletedFirst Submitted
Initial submission to the registry
May 29, 2008
CompletedFirst Posted
Study publicly available on registry
June 3, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedAugust 18, 2016
August 1, 2016
2.5 years
May 29, 2008
August 17, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Glucose control
HbA1c and fasting blood glucose
12 months
Secondary Outcomes (5)
Glycaemia, Insulinemia, Incretins during a standardized meal test at 10% of weight loss
3 months
Weight loss
60 months
Glycaemia, Insulinemia, Incretins, and D-xylose during a normalized(standardized) meal
12 months
Glycaemia, insulinemia, incretins, and D-xylose during a normalized(standardized) meal
60 months
Diabetes remission
60 months
Study Arms (3)
Roux-en-Y gastric bypass
Patients with class 3 obesity and type 2 diabetes submitted to Roux-en-Y gastric bypass
Adjustable gastric banding
Patients with class 3 obesity and type 2 diabetes submitted to adjustable gastric banding
Healthy controls
Non-obese, non-diabetic adults
Interventions
Laparoscopic Roux-en-Y gastric bypass
Laparoscopic adjustable gastric band
Eligibility Criteria
Candidate for bariatric surgery (Roux-en-Y gastric bypass OR adjustable gastric band) with class 3 obesity (body mass index ≥ 35 kg/m2) and type 2 diabetes (ADA definition) OR healthy volunteers
You may qualify if:
- Age between 18 and 70 years AND
- BMI \> 35
- Type 2 diabetes
- Obesity for more than 5 years OR
- normoglycemia
- BMI\< 30
You may not qualify if:
- Secondary obesity due to an endocrinopathy
- Chronic pathology (neoplasia, cirrhosis, disease of system)
- Psychosis, alcoholic addiction or narcotics.
- Contre-indications to the anaesthesia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Lille University Hospital
Lille, Nord, 59037, France
Biospecimen
serum and plasma during meal test (0, 30, 60, 90, 120, 180 min)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Francois PATTOU
Lille University Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 29, 2008
First Posted
June 3, 2008
Study Start
May 1, 2004
Primary Completion
November 1, 2006
Study Completion
September 1, 2012
Last Updated
August 18, 2016
Record last verified: 2016-08