Single Loop DJB Sleeve Gastrectomy for Poorly Controlled T2DM

NCT ID: NCT03125369

Last Updated: 2017-04-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2018-05-31

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.

Conditions

Diabetes Mellitus; Obesity; Bariatric Surgery Candidate; Weight Loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Duodenojejunal bypass

patients receive sleeve gastrectomy plus duodeno-jejunal bypass

Group Type: EXPERIMENTAL

Sleeve gastrectomy + duodeno-jejunal bypass

Intervention Type: PROCEDURE

Roux-en-Y gastric bypass

patients receive roux-Y gastric bypass

Group Type: ACTIVE_COMPARATOR

Roux-Y gastric bypass

Intervention Type: PROCEDURE

Interventions

Sleeve gastrectomy + duodeno-jejunal bypass

Intervention Type: PROCEDURE

Roux-Y gastric bypass

Intervention Type: PROCEDURE

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
• inmates

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Enders K.W. Ng

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Enders KW Ng, Professor

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

Chinese University of Hong Kong

Hong Kong, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Enders Ng, MD

Role: CONTACT

endersng@surgery.cuhk.edu.hk

+852 26322956

Candice Lam, BN

Role: CONTACT

candicelam@surgery.cuhk.edu.hk

+852 26322956

Facility Contacts

Enders Ng, MD

Role: primary

endersng@surgery.cuhk.edu.hk

+852 26322956

Other Identifiers

SLDJBSG_DM

Identifier Type: -

Identifier Source: org_study_id