Prospective Randomized Trial Comparing Single Loop Duodenojejunal Bypass With Sleeve Gastrectomy Versus Standard Roux-en-Y Gastric Bypass in Patients With Poorly Controlled Type 2 Diabetes Mellitus: From Clinical Outcomes to Hormonal Mechanism
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- % of patient achieve HbA1c<6%
研究概览
简要总结
Type 2 diabetes mellitus (T2DM) is a chronic progressive illness affecting a substantial percentage of the general population. While pharmacotherapy remains the mainstay of treatment, around 60% of patients cannot achieve the recommended goals for diabetic control. Weight control is a well-known essential component in normalizing blood glucose level in T2DM. The term metabolic surgery is recently introduced and it is now increasingly accepted as a valid option for obese T2DM patients with poor glycemic control despite optimal medical therapy. While laparoscopic roux-en-Y gastric bypass (RYGBP) is the gold-standard bariatric/metabolic procedure in many countries, it is not widely accepted in Asia. Recently, a novel bypass technique called single loop duodenojejunal bypass with sleeve gastrectomy (SLDJB-SG) has been developed trying to tackle most drawbacks of RYGBP. Realizing there is a knowledge gap in applying the new duodenojejunal bypass procedure to obese T2DM patients, we propose to investigate and compare the efficacy of glycemic control and functional outcomes of SLDJB-SG with conventional RYGBP.
详细描述
Aim of study:
To investigate and compare the safety profile, functional outcomes, efficacy in diabetic control and changes of hormonal profile of laparoscopic single loop duodenojejunal bypass plus sleeve gastrectomy (SLDJB-SG) versus the conventional standard roux-en-Y gastric bypass (RYGBP).
Hypothesis
The efficacy of glycemic control and functional outcomes of SLDJB-SG is better than conventional RYGBP, and is a more suitable option for obese Chinese diabetic patients.
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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged between 20 to 65 years
- •at least 2 years of T2DM
- •a BMI between 28 to 42 kg/m2
- •a HbA1c level above 7% despite multiple oral medications (> 2) at higher than or equal to half-maximal dose, or already using insulin injection for more than 6 months
- •no active cardiovascular diseases, and
- •a ASA grade II or below
- •a fasting C-peptide < 0.6ug/L
排除标准
- •significant anaesthetic risk ASA grade III or above
- •history of diabetic ketoacidosis
- •uncontrolled DM with HbA1c > 12%
- •malignancy diagnosed within 5 years
- •chronic renal failure requiring dialysis
- •previous upper abdominal surgery affecting gastroduodenal configuration
- •major psychiatric illness including major depression and substance abuse
- •pregnancy or ongoing breast-feeding
结局指标
主要结局
% of patient achieve HbA1c<6%
时间窗: 1 year
次要结局
- Total blood loss(during operation)
- operation time(during operation)
- Perioperative complications(30 days)
- mortality(30 days)
- Postoperative hospital stay(during index operation)
- Excessive body weight loss (kg)(6 months & 1 year)
- BMI change (kg/m^2)(6 months & 1 year)
研究者
Enders K.W. Ng
Professor
Chinese University of Hong Kong
