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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Diabetes Mellitus
- Sponsor
- Chinese University of Hong Kong
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- % of patient achieve HbA1c<6%
- Last Updated
- 9 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Enders K.W. Ng
Professor
Chinese University of Hong Kong
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
% of patient achieve HbA1c<6%
Time Frame: 1 year
Secondary Outcomes
- 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)