Single Loop DJB Sleeve Gastrectomy for Poorly Controlled T2DM

NCT03125369 | Unknown DMC

• 1 other identifier: SLDJBSG_DM
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus; Obesity; Bariatric Surgery Candidate; Weight Loss

Outcome Measures

Primary Outcomes (1)

• % of patient achieve HbA1c<6%

  1 year

Secondary Outcomes (7)

• operation time

  during operation

• Total blood loss

  during operation

• Perioperative complications

  30 days

• mortality

  30 days

• Postoperative hospital stay

  during index operation

Study Arms (2)

Duodenojejunal bypass

EXPERIMENTAL

patients receive sleeve gastrectomy plus duodeno-jejunal bypass

Procedure: Sleeve gastrectomy + duodeno-jejunal bypass

Roux-en-Y gastric bypass

ACTIVE COMPARATOR

patients receive roux-Y gastric bypass

Procedure: Roux-Y gastric bypass

Interventions

Sleeve gastrectomy + duodeno-jejunal bypass PROCEDURE

Duodenojejunal bypass

Roux-Y gastric bypass PROCEDURE

Roux-en-Y gastric bypass

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Chinese University of Hong Kong

Hong Kong, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus; Obesity; Weight Loss

Interventions

Gastric Bypass

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Intervention Hierarchy (Ancestors)

Bariatric Surgery; Bariatrics; Obesity Management; Therapeutics; Gastroenterostomy; Anastomosis, Surgical; Surgical Procedures, Operative; Digestive System Surgical Procedures

Study Officials

• Enders KW Ng, Professor

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Enders Ng, MD

CONTACT

+852 26322956; endersng@surgery.cuhk.edu.hk

Candice Lam, BN

CONTACT

+852 26322956; candicelam@surgery.cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 29, 2016
• First Posted: April 24, 2017
• Study Start: August 1, 2015
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: April 24, 2017

Record last verified: 2017-04

Locations

CN (1)