Roux-en-Y Gastric Bypass for BMI 27-32 Type 2 Diabetes vs Best Medical Treatment
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Number of subjects achieving HBA1c of 6% without diabetic medication
研究概览
简要总结
Investigators aim to show that Roux-en-Y Gastric Bypass (RYGB) is superior to best medical treatment in reaching well-defined treatment end points in Asian subjects of BMI 27-32 with type 2 Diabetes (DM2). Investigators also hope to show that successful RYGB will reduce resource utilization in the near term with similar projected reduction over the medium to long term.
详细描述
40 subjects with DM2 will be recruited, randomised into two arms. The surgical arm will be subjected to RYGB. The medical arm will be treated maximally utilising the best means available and following internationally available protocol/guidelines. The study population will be subjected to a set of tests which is over and above the standard tests for similar groups of patients undergoing standard care (details below). Some test samples will be bio-banked. Treatment end points and follow up protocol will be the same for each treatment arm. The International Diabetic Federation (IDF) in 2011 recommended that bariatric surgery should be considered an alternative treatment option for those Asian DM2 subjects with BMI of 27 or above. Data for the effectiveness of Bariatric Surgery for those DM subjects with lower BMI is not as well established as those with higher BMI. There is scant good quality data, especially from Asian subjects. As their treatment is totally funded by the research project, subjects on the non surgical treatment arm will benefit from the more intense management of their disease with no restriction due to cost. The surgical arm will also be fully funded by the research project. They will be exposed to the standard risks associated with this type of surgery. Subjects in both arms will have to provide more blood and other samples than usual and has to follow visits protocol as close as possible. RYGB is a major surgical procedure, with significant potential complications; during the process of surgery and afterwards, both short and long term. Procedure related mortality is about 0.3%. Major complications that may require surgical intervention includes: anastomotic leakage about 3-4%, bleeding 3%, infection 3%, venous thrombo-embolism 1%. Some of these complications will require prolong hospitalisation. After surgery, loose stool, dumping syndrome, anastomotic ulcers can occur in less than 3%.Life long dietary supplement will be required. Longer term post surgical complications include intestinal obstruction due to adhesions or internal hernia, about 2%, further surgery may be needed. This risk is lifelong. Nutritional deficiencies, especially if not compliant with regular supplement intake, may occur. Drug allergies can occur; from simple rash to life threatening anaphylactic reaction. Blood taking can cause bruising, pain at the puncture site and sometimes fainting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Established diagnosis of DM2 = or < 10 years
- •HBA1c ≥ 8%, on maximum treatment from primary care physician
- •At least one of the following co-morbidities on treatment: hypertension, hyperlipidaemia, micro/macro-proteinuria or ≤class I nephropathy, retinopathy.
排除标准
- •Subjects who had previous Bariatric surgery or extensive upper abdominal surgery
- •Pregnant subjects.
- •Nephropathy requiring dialysis
- •Subjects who are not fit for general anaesthesia.
- •Subjects who are unsuitable for RYGB for whatever reason, medical/surgical/psychological.
- •Subjects who are unwilling or possibly unable to participate in the follow up process.
- •Subjects who are reluctant to be randomised into the two study groups.
- •Subjects who suffers from unstable psychiatric illness
- •Subjects who are active substance abusers
- •Glutamic acid decarboxylase antibody positive.
- •fasting C-peptide < 300 pmol/L
研究组 & 干预措施
Roux-en-Y Gastric Bypass (RYGB)
Roux-en-Y Gastric Bypass (RYGB) as per standard surgical protocol, with a 30 cc gastric pouch, 50 cm biliopancreatic limb and 100cm gastrointestinal limb.
干预措施: Roux-en-Y Gastric Bypass (RYGB) (Procedure)
Best Medical Treatment
Anti-diabetic medications provided (Mono- or Combination- therapy):
Incretin analogues: Liraglutide up to 3 mg daily Or DPP-4 Inhibitors: Sitagliptin up to 100 mg daily, Linagliptin up to 5mg daily Xenical: Up to 120 mg tds SGLT2 inhibitors: Empagliflozin up to 25mg daily, Canagliflozin up to 300mg daily Participants will also take lipids & BP medications according to standard of care.
干预措施: Incretin analogues (Drug)
Best Medical Treatment
Anti-diabetic medications provided (Mono- or Combination- therapy):
Incretin analogues: Liraglutide up to 3 mg daily Or DPP-4 Inhibitors: Sitagliptin up to 100 mg daily, Linagliptin up to 5mg daily Xenical: Up to 120 mg tds SGLT2 inhibitors: Empagliflozin up to 25mg daily, Canagliflozin up to 300mg daily Participants will also take lipids & BP medications according to standard of care.
干预措施: Xenical (Drug)
Best Medical Treatment
Anti-diabetic medications provided (Mono- or Combination- therapy):
Incretin analogues: Liraglutide up to 3 mg daily Or DPP-4 Inhibitors: Sitagliptin up to 100 mg daily, Linagliptin up to 5mg daily Xenical: Up to 120 mg tds SGLT2 inhibitors: Empagliflozin up to 25mg daily, Canagliflozin up to 300mg daily Participants will also take lipids & BP medications according to standard of care.
干预措施: SGLT2 inhibitors (Drug)
Best Medical Treatment
Anti-diabetic medications provided (Mono- or Combination- therapy):
Incretin analogues: Liraglutide up to 3 mg daily Or DPP-4 Inhibitors: Sitagliptin up to 100 mg daily, Linagliptin up to 5mg daily Xenical: Up to 120 mg tds SGLT2 inhibitors: Empagliflozin up to 25mg daily, Canagliflozin up to 300mg daily Participants will also take lipids & BP medications according to standard of care.
干预措施: DPP-4 Inhibitors (Drug)
结局指标
主要结局
Number of subjects achieving HBA1c of 6% without diabetic medication
时间窗: at 12 month after randomisation
The primary endpoint is to compare Roux-en-Y Gastric Bypass (RYGB) vs best medical treatment for Asian subjects of BMI 27-32 with poorly controlled type 2 Diabetes (DM2) in achieving a glycated haemoglobin level of 6% or less at 12 months after randomisation, and beyond till the end of the study period, without diabetic medications; and also systolic Blood Pressure of \<130 mm HG, and LDL of \<100mg/dl.
number of subjects achieving LDL level of <100mg/dl without lipid lowering medication
时间窗: 12 months post randomisation
The primary endpoint is to compare Roux-en-Y Gastric Bypass (RYGB) vs best medical treatment for Asian subjects of BMI 27-32 with poorly controlled type 2 Diabetes (DM2) in achieving a glycated haemoglobin level of 6% or less at 12 months after randomisation, and beyond till the end of the study period, without diabetic medications; and also systolic Blood Pressure of \<130 mm HG, and LDL of \<100mg/dl.
Number of subjects achieving systolic BP <130mm hg without antihypertension medication
时间窗: 12 months post randomisation
The primary endpoint is to compare Roux-en-Y Gastric Bypass (RYGB) vs best medical treatment for Asian subjects of BMI 27-32 with poorly controlled type 2 Diabetes (DM2) in achieving a glycated haemoglobin level of 6% or less at 12 months after randomisation, and beyond till the end of the study period, without diabetic medications; and also systolic Blood Pressure of \<130 mm HG, and LDL of \<100mg/dl.
次要结局
- serum c-peptide level(12 months post randomisation)
- serum lipid levels(12 months post randomisation)
- fasting plasma glucose(12 months after Randomisation)
- Fasting Insulin(12 months after radomisation)
- C-reactive protein level(12 months post randolmisation)
- change in medications usage(12 months post randomisation)
- changes in gut hormones levels(12 months post randomisation)
- changes in metabolic hormones level(12 months post randomisation)
- health resource utilisation(12 months post randomisation)
- HOMA-IR(12 months post randomisation)
- Blood Pressure measurement(12 months post randomisation)
- number of adverse events(12 months post randomisaiton)
- Weight loss(12 months post randomisation)
研究者
Anton Cheng
Dr Anton Cheng
Khoo Teck Puat Hospital