The Effects of Glycemic Optimization Before Gastric Bypass Surgery (GLUCOSURG2)
Investigation of the Effects of Glycaemic Optimisation Before Gastric Bypass Surgery on the Glycaemic Remission and Microvascular Complication Rates of Type 2 Diabetes Mellitus
Metabolic surgery such as gastric bypass, gastric banding or sleeve gastrectomy operations can cause rapid and uncontrolled reductions in blood glucose. There is limited information on whether:
- metabolic surgery is superior to modern medical care for glycaemic control and type 2 diabetes remission.
- metabolic surgery is safe for microvascular complications of Type 2 diabetes
- good glycaemic control pre surgery has any effects on the long term glycaemia and complications of type 2 diabetes.
This study aims to assess:
- whether metabolic surgery is better for diabetes control compared to medical treatment.
- whether metabolic surgery is safe for eye, nerve and kidney complications.
- whether good sugar control before metabolic surgery improves the long term effects of sugar control and microvascular complications.
연구 개요
상세 설명
This is a prospective study involving 150 patients with type 2 diabetes mellitus (T2DM) and obesity. One hundred patients will undergo gastric bypass surgery whilst 50 will be treated with best medical care. The surgical patient group will be randomised to either immediate surgery or 3 months of medical glycaemic optimisation followed by surgery (n=50 group).
Intervention Group A: Patients will undergo gastric bypass surgery within 3 months after randomisation without any pre operative optimisation of glycaemic control.
Group B: Patients will undergo gastric bypass 3-6 months after randomisation. During this period the group will receive modern best medical care based on the American Diabetes Association (ADA)/European Association for the Study of Diabetes (EASD) guidelines. Glycaemic optimisation will be achieved with particular attention to the avoidance of hypoglycaemia.
Group C: Obese patients with T2DM (who choose not to have surgery) will be treated with best medical care based on the ADA/EASD guidelines including anti-diabetes/obesity pharmacotherapy, access to a trained dietician and exercise programme.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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London, 영국, W6 8RF
- Charing Cross Hospital
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London, 영국, W6 8FR
- Imperial Weight Centre, Charing Cross Hospital,
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참여기준
자격 기준
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건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Adult patients with T2DM and BMI above 35kg/m2
- HbA1c ≥ 8.5% and/or the presence of at least one microvascular complication.
Exclusion Criteria:
- End stage retinopathy, nephropathy or neuropathy.
공부 계획
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디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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간섭 없음: gastric bypass
Group A: Patients will undergo gastric bypass surgery within 3 months after randomisation without any pre operative optimisation of glycaemic control.
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활성 비교기: Gastric bypass 2
Gastric bypass 2 (Group B):Patients will undergo gastric bypass 3-6 months after randomisation.
During this period the group will receive modern best medical care based on the American Diabetes Association (ADA)/European Association for the Study of Diabetes (EASD) guidelines.
Glycaemic optimisation will be achieved in a gradual manner with particular attention to the avoidance of hypoglycaemia
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Optimise glucose control within 3 months before operation
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Composite of Fasting Glucose, Glycosylated Haemoglobin c and Rates of Type 2 Diabetes Mellitus Remission.
기간: 1 year
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A patient is considered to have achieved remission of T2F according to the American Diabetes Association criteria if they have fasting glucose below 6mmol/L AND HbA1c below 6% AND no medication for diabetes. Thus, a patient needs to achieve all of the three criteria (fasting glucose, HbA1C, and no medication) before being considered to be in remission. If a patient only achieves 2 of the criteria (fasting glucose and no medication) but the HbA1C is above 6% then they are not considered to be in remission. The outcome measure is calculated as the count of participants achiving the above criteria |
1 year
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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A Composite of Microvascular Complications
기간: 1 year
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A composite of microvascular complications. Microvascular events will be defined as new or worsening nephropathy, retinopathy or neuropathy. The outcome measure is calculated as the count of participants developing any of the microvascular events. |
1 year
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공동 작업자 및 조사자
수사관
- 수석 연구원: Carel le Roux, MBChB, PhD, Imperial College London
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 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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