Single Loop DJB Sleeve Gastrectomy for Poorly Controlled T2DM

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Weight Loss, Diabetes Mellitus, Obesity, Bariatric Surgery Candidate

Intervention / Treatment
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* Procedure: Sleeve gastrectomy + duodeno-jejunal bypass
* Procedure: Roux-Y gastric bypass


Participation Criteria
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Eligibility Criteria
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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 inmates

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Duodenojejunal bypass<br>patients receive sleeve gastrectomy plus duodeno-jejunal bypass | Procedure: Sleeve gastrectomy + duodeno-jejunal bypass<br> <br> |
| Active Comparator: Roux-en-Y gastric bypass<br>patients receive roux-Y gastric bypass | Procedure: Roux-Y gastric bypass<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % of patient achieve HbA1c<6% |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| operation time |  | during operation | 
| Total blood loss | Total blood loss data from operation record | 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 |