Single Loop DJB Sleeve Gastrectomy for Poorly Controlled T2DM

Not Applicable

• Conditions: Bariatric Surgery Candidate; Weight Loss; Diabetes Mellitus; Obesity

• Registration Number: NCT03125369
• Lead Sponsor: Chinese University of Hong Kong

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.

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2016-04-29
• Status Verified: 2017-04
• Study First Submitted QC: 2017-04-19
• Last Update Submitted: 2017-04-19
• Study First Posted: 2017-04-24
• Last Update Posted: 2017-04-24
• Primary Completion: 2018-05
• Study Completion: 2018-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
% of patient achieve HbA1c<6%	1 year

Secondary Outcome Measures

Name	Time	Method
Postoperative hospital stay	during index operation
Total blood loss	during operation	Total blood loss data from operation record
operation time	during operation
Perioperative complications	30 days
mortality	30 days
Excessive body weight loss (kg)	6 months & 1 year
BMI change (kg/m^2)	6 months & 1 year

Trial Locations

Locations (1)

Chinese University of Hong Kong; 🇨🇳 Hong Kong, China