Single Loop DJB Sleeve Gastrectomy for Poorly Controlled T2DM

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03125369
• Other study ID #: SLDJBSG_DM
• Status: Recruiting
• Phase: N/A
• First received: April 29, 2016
• Last updated: April 19, 2017
• Start date: August 2015
• Est. completion date: May 2018

Study information

• Verified date: April 2017
• Source: Chinese University of Hong Kong
• Contact: Enders Ng, MD
• Phone: +852 26322956
• Email: endersng[@]surgery.cuhk.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: May 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Diabetes Mellitus
• Obesity
• Weight Loss

Intervention

Procedure:
• Sleeve gastrectomy + duodeno-jejunal bypass

• Roux-Y gastric bypass

Locations

Country	Name	City	State
China	Chinese University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% of patient achieve HbA1c<6%		1 year
Secondary	operation time		during operation
Secondary	Total blood loss	Total blood loss data from operation record	during operation
Secondary	Perioperative complications		30 days
Secondary	mortality		30 days
Secondary	Postoperative hospital stay		during index operation
Secondary	Excessive body weight loss (kg)		6 months & 1 year
Secondary	BMI change (kg/m^2)		6 months & 1 year