Longitudinal Cohort Study Comparing 2 Surgical Techniques in Patients With Class 3 Obesity and Type 2 Diabetes (OBEDIAB)
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.
연구 개요
상세 설명
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
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Nord
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Lille, Nord, 프랑스, 59037
- Lille University Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
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
설명
Inclusion Criteria:
- Age between 18 and 70 years AND
- BMI > 35
- Type 2 diabetes
- Obesity for more than 5 years OR
- normoglycemia
- BMI< 30
Exclusion Criteria:
- Secondary obesity due to an endocrinopathy
- Chronic pathology (neoplasia, cirrhosis, disease of system)
- Psychosis, alcoholic addiction or narcotics.
- Contre-indications to the anaesthesia
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
Roux-en-Y gastric bypass
Patients with class 3 obesity and type 2 diabetes submitted to Roux-en-Y gastric bypass
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Laparoscopic Roux-en-Y gastric bypass
다른 이름들:
|
|
Adjustable gastric banding
Patients with class 3 obesity and type 2 diabetes submitted to adjustable gastric banding
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Laparoscopic adjustable gastric band
다른 이름들:
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Healthy controls
Non-obese, non-diabetic adults
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Glucose control
기간: 12 months
|
HbA1c and fasting blood glucose
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12 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Glycaemia, Insulinemia, Incretins during a standardized meal test at 10% of weight loss
기간: 3 months
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Concentration curves of glycaemia, insulinemia, incretins, and D-xylose during a standardized mixed meal test
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3 months
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Weight loss
기간: 60 months
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Body mass index
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60 months
|
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Glycaemia, Insulinemia, Incretins, and D-xylose during a normalized(standardized) meal
기간: 12 months
|
Concentration curves of glycaemia, insulinemia, incretins, and D-xylose during a standardized mixed meal test
|
12 months
|
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Glycaemia, insulinemia, incretins, and D-xylose during a normalized(standardized) meal
기간: 60 months
|
Concentration curves of glycaemia, insulinemia, incretins, and D-xylose during a standardized mixed meal test
|
60 months
|
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Diabetes remission
기간: 60 months
|
HbA1c < 6.5% AND fasting blood glucose < 7.0 mmol/L in absence of antidiabetic drug
|
60 months
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Francois PATTOU, Lille University Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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