Single Loop DJB Sleeve Gastrectomy for Poorly Controlled T2DM

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

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.

Study Overview

• Status: Unknown
• Conditions: Obesity; Diabetes Mellitus; Weight Loss; Bariatric Surgery Candidate
• Intervention / Treatment: Procedure: Sleeve gastrectomy + duodeno-jejunal bypass; Procedure: Roux-Y gastric bypass

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 Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Enders Ng, MD; Phone Number: +852 26322956; Email: endersng@surgery.cuhk.edu.hk
• Study Contact Backup: Name: Candice Lam, BN; Phone Number: +852 26322956; Email: candicelam@surgery.cuhk.edu.hk

Study Locations

• China
  • Hong Kong, China
    • Recruiting
    • Chinese University of Hong Kong
    • Contact: Enders Ng, MD; Phone Number: +852 26322956; Email: endersng@surgery.cuhk.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Investigators: Principal Investigator: Enders KW Ng, Professor, Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Anticipated): May 1, 2018
• Study Completion (Anticipated): May 1, 2018

Study Registration Dates

• First Submitted: April 29, 2016
• First Submitted That Met QC Criteria: April 19, 2017
• First Posted (Actual): April 24, 2017

Study Record Updates

• Last Update Posted (Actual): April 24, 2017
• Last Update Submitted That Met QC Criteria: April 19, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Body Weight; Body Weight Changes; Diabetes Mellitus; Weight Loss
• Other Study ID Numbers: SLDJBSG_DM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED