Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2026-01-06 @ 8:27 PM
Study NCT ID:
NCT03125369
Status:
UNKNOWN
Last Update Posted:
2017-04-24
First Post:
2016-04-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Single Loop DJB Sleeve Gastrectomy for Poorly Controlled T2DM
Sponsor:
Chinese University of Hong Kong
Organization:
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2017-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: