Single Loop DJB Sleeve Gastrectomy for Poorly Controlled T2DM

The Chinese University of Hong Kong

Status: Unknown

Conditions: Weight Loss; Diabetes Mellitus; Bariatric Surgery Candidate; Obesity

Treatments: Procedure: Sleeve gastrectomy + duodeno-jejunal bypass; Procedure: Roux-Y gastric bypass

Study type: Interventional

Funder types: Other

Identifiers

NCT03125369

SLDJBSG_DM

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Duodenojejunal bypass

Experimental group

Description:

patients receive sleeve gastrectomy plus duodeno-jejunal bypass

Treatment:

Procedure: Sleeve gastrectomy + duodeno-jejunal bypass

Roux-en-Y gastric bypass

Active Comparator group

Description:

patients receive roux-Y gastric bypass

Treatment:

Procedure: Roux-Y gastric bypass