ObesityOBEDIABNCT00688974
Longitudinal Cohort Study Comparing 2 Surgical Techniques in Patients With Class 3 Obesity and Type 2 Diabetes
An observational study of Obesity and Type 2 Diabetes, run by University Hospital, Lille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Type 2 Diabetes
- What is being tested?
- Roux-en-Y gastric bypass and Adjustable gastric band
- Type of treatment
- Surgery or procedure
- How many people
- 56 participants
- Where
- 1 siteFrance
- Study dates
- May 2004to Sep 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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
Who may be able to join
- Age between 18 and 70 years AND
- BMI > 35
- Type 2 diabetes
- Obesity for more than 5 years OR
- normoglycemia
- BMI< 30
Who cannot join
- Secondary obesity due to an endocrinopathy
- Chronic pathology (neoplasia, cirrhosis, disease of system)
- Psychosis, alcoholic addiction or narcotics.
- Contre-indications to the anaesthesia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Longitudinal Cohort Study Comparing 2 Surgical Techniques (Roux-en-Y Gastric Bypass and Adjustable Gastric Banding) in Patients With Class 3 Obesity and Type 2 Diabetes
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.
Read the detailed description
Type 2 diabetes is a condition often associated with obesity and often difficult to control. In patients with severe obesity, surgical treatment allows a sustainable weight loss and higher than that obtained with other treatments available. In most cases, surgery also reduces significantly the comorbidities of obesity and diabetes in particular. Among the various technical options, adjustable gastric band (AGB) is the simplest and by far the most used in France.
Roux-en-Y gastric bypass (RYGB) is a more complicated intervention combining gastrointestinal malabsorption- duodeno-jejunal and gastric reduction and allows a higher weight loss. Several studies also suggest that the technique has a remarkable efficiency on glycemic control, justifying the extension of its readings/indications. No study controlled, however, has compared these two techniques.
The objective of this study is to compare the efficiency of RYGB vs AGB on glycemic control in type 2 diabetes. Although some studies have compared AGB and RYGB, none have compared their effectiveness on post prandial glucose control in patients with diabetes. It is generally recognized that the effectiveness of RYGB on diabetes is independent of the weight loss, but this has never been demonstrated.
By demonstrating the superiority of RYGB vs AGB, and identifying the responsible mechanisms, the study will expand the indications of RYGB in the treatment of type 2 diabetes. Weight loss surgery offers a unique model for the clinical study of the pathophysiology of type 2 diabetes.
Main objective:
- To compare the effectiveness of RYGB vs AGB on glucose control in obese patients with type 2 diabetes.
Secondary Objectives:
- demonstrate that the better outcome achieved with RYGB is independent of weight loss.
- Identify the mechanisms underlying the better outcome of RYGB
- Conditions
- Obesity, Type 2 Diabetes
- Being tested
- Roux-en-Y gastric bypass, Adjustable gastric band
- Keywords
- type 2 diabetes, obesity, gastric bypass, adjustable gastric banding, BMI > 35., obesity for more than 5 years
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Roux-en-Y gastric bypassProcedure or surgery
Also called Gastric bypass
Laparoscopic Roux-en-Y gastric bypass
Adjustable gastric bandProcedure or surgery
Also called Gastric Banding
Laparoscopic adjustable gastric band
| Study group | Role | What they receive |
|---|---|---|
| Roux-en-Y gastric bypass | Patients with class 3 obesity and type 2 diabetes submitted to Roux-en-Y gastric bypass Receives: Procedure: Roux-en-Y gastric bypass | |
| Adjustable gastric banding | Patients with class 3 obesity and type 2 diabetes submitted to adjustable gastric banding Receives: Procedure: Adjustable gastric band | |
| Healthy controls | Non-obese, non-diabetic adults |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose control
HbA1c and fasting blood glucose
Measured: 12 months
Secondary outcomes (5)
Glycaemia, Insulinemia, Incretins during a standardized meal test at 10% of weight loss
Concentration curves of glycaemia, insulinemia, incretins, and D-xylose during a standardized mixed meal test
Measured: 3 months
Weight loss
Body mass index
Measured: 60 months
Glycaemia, Insulinemia, Incretins, and D-xylose during a normalized(standardized) meal
Concentration curves of glycaemia, insulinemia, incretins, and D-xylose during a standardized mixed meal test
Measured: 12 months
Glycaemia, insulinemia, incretins, and D-xylose during a normalized(standardized) meal
Concentration curves of glycaemia, insulinemia, incretins, and D-xylose during a standardized mixed meal test
Measured: 60 months
Diabetes remission
HbA1c < 6.5% AND fasting blood glucose < 7.0 mmol/L in absence of antidiabetic drug
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2008 (estimated)
- Study startMay 2004
- Primary completionNov 2006
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francois PATTOU, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00688974
- Sponsor's protocol ID
- DGS 2004/0123
- Other IDs
- 2004/0412
- Acronym
- OBEDIAB
- Status last verified
- Aug 2016
- First submitted
- 29 May 2008
- Last updated
- 18 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Cohort Study Comparing 2 Surgical Techniques (Roux-en-Y Gastric Bypass and Adjustable Gastric Banding) in Patients With Class 3 Obesity and Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00688974
- Acronym / sponsor ID
- OBEDIAB / DGS 2004/0123
- Conditions
- Obesity, Type 2 Diabetes
- Keywords
- type 2 diabetes, obesity, gastric bypass, adjustable gastric banding, BMI > 35., obesity for more than 5 years
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- May 2004
- Primary completion
- Nov 2006 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 3 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Type 2 diabetes is a condition often associated with obesity and often difficult to control. In patients with severe obesity, surgical treatment allows a sustainable weight loss and higher than that obtained with other treatments available. In most cases, surgery also reduces significantly the comorbidities of obesity and diabetes in particular. Among the various technical options, adjustable gastric band (AGB) is the simplest and by far the most used in France.
Roux-en-Y gastric bypass (RYGB) is a more complicated intervention combining gastrointestinal malabsorption- duodeno-jejunal and gastric reduction and allows a higher weight loss. Several studies also suggest that the technique has a remarkable efficiency on glycemic control, justifying the extension of its readings/indications. No study controlled, however, has compared these two techniques.
The objective of this study is to compare the efficiency of RYGB vs AGB on glycemic control in type 2 diabetes. Although some studies have compared AGB and RYGB, none have compared their effectiveness on post prandial glucose control in patients with diabetes. It is generally recognized that the effectiveness of RYGB on diabetes is independent of the weight loss, but this has never been demonstrated.
By demonstrating the superiority of RYGB vs AGB, and identifying the responsible mechanisms, the study will expand the indications of RYGB in the treatment of type 2 diabetes. Weight loss surgery offers a unique model for the clinical study of the pathophysiology of type 2 diabetes.
Main objective:
- To compare the effectiveness of RYGB vs AGB on glucose control in obese patients with type 2 diabetes.
Secondary Objectives:
- demonstrate that the better outcome achieved with RYGB is independent of weight loss.
- Identify the mechanisms underlying the better outcome of RYGB
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Roux-en-Y gastric bypass | – | Procedure: Roux-en-Y gastric bypassPatients with class 3 obesity and type 2 diabetes submitted to Roux-en-Y gastric bypass |
| Adjustable gastric banding | – | Procedure: Adjustable gastric bandPatients with class 3 obesity and type 2 diabetes submitted to adjustable gastric banding |
| Healthy controls | – | –Non-obese, non-diabetic adults |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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
Key inclusion criteria (6 listed)
- Age between 18 and 70 years AND
- BMI > 35
- Type 2 diabetes
- Obesity for more than 5 years OR
- normoglycemia
Key exclusion criteria (4 listed)
- Secondary obesity due to an endocrinopathy
- Chronic pathology (neoplasia, cirrhosis, disease of system)
- Psychosis, alcoholic addiction or narcotics.
- Contre-indications to the anaesthesia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Roux-en-Y gastric bypassAlso: Gastric bypassLaparoscopic Roux-en-Y gastric bypass | Procedure or surgery | Roux-en-Y gastric bypass |
| Adjustable gastric bandAlso: Gastric BandingLaparoscopic adjustable gastric band | Procedure or surgery | Adjustable gastric banding |
Primary outcome
Glucose control
Time frame: 12 months
HbA1c and fasting blood glucose
5 secondary outcomes
Glycaemia, Insulinemia, Incretins during a standardized meal test at 10% of weight loss
Time frame: 3 months
Weight loss
Time frame: 60 months
Glycaemia, Insulinemia, Incretins, and D-xylose during a normalized(standardized) meal
Time frame: 12 months
Glycaemia, insulinemia, incretins, and D-xylose during a normalized(standardized) meal
Time frame: 60 months
Diabetes remission
Time frame: 60 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francois PATTOU principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Type 2 Diabetes, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glucose control (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2016.