Clinical trial NCT03125369: Single Loop DJB Sleeve Gastrectomy for Poorly Controlled T2DM
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus
Obesity
Bariatric Surgery Candidate
Weight Loss
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2017-04-24
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: % of patient achieve HbA1c<6%
timeFrame: 1 year
Secondary outcomes:
measure: operation time
timeFrame: during operation
measure: Total blood loss
timeFrame: during operation
measure: Perioperative complications
timeFrame: 30 days
measure: mortality
timeFrame: 30 days
measure: Postoperative hospital stay
timeFrame: during index operation
measure: Excessive body weight loss (kg)
timeFrame: 6 months & 1 year
measure: BMI change (kg/m^2)
timeFrame: 6 months & 1 year
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Chinese University of Hong Kong
Study officials:
affiliation: Chinese University of Hong Kong
name: Enders KW Ng, Professor
role: PRINCIPAL_INVESTIGATOR
References: