跳至主要内容
临床试验/NCT03125369
NCT03125369Unknown不适用

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

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2015年8月最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Enders K.W. Ng

Professor

Chinese University of Hong Kong

研究点 (1)

Loading locations...

相似试验