DMBSS-A Randomized Trial of Different Laparoscopic Gastric Bypass Surgery in Patients With Obesity-related T2DM

Not Applicable

• Conditions: Diabetes Mellitus Type 2 in Obese
• Interventions: Procedure: LRYGB; Procedure: SADJB; Procedure: LMGB

• Registration Number: NCT01989988
• Lead Sponsor: Min-Sheng General Hospital

Brief Summary

The investigators would like to conduct a randomized clinical trial to compare the efficacy of diabetes treatment between different gastric bypass procedures involving type 2 diabetics patients with BMI from 27.5 to 35 kg/m2

Detailed Description

The investigators would like to conduct a randomized clinical trial to compare the efficacy of diabetes treatment between different gastric bypass procedures involving type 2 diabetics patients with BMI from 27.5 to 35 kg/m2. This program will determine the relative effectiveness among LMGB 、RYGB and SADJB .The primary end point including HbA1C\<6.0%, LDL-C\<100mg/dl and SBP\<130mmHg at one year after surgery. Through this study, the investigators may understand which gastric bypass is the best for type 2 diabetic's treatment. The investigators also hope some new treatment modulation may be developed.

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-01-22
• Status Verified: 2013-11
• Study First Submitted QC: 2013-11-15
• Last Update Submitted: 2013-11-15
• Study First Posted: 2013-11-21
• Last Update Posted: 2013-11-21
• Primary Completion: 2015-07
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Age 20 to 67 years
• Diagnosed with T2DM at least 6 months prior to enrollment, under the active care of a doctor for at least the six months prior to enrollment, HbA1c ≥ 7.5 %
• Body Mass Index (BMI) ≥ 27.5 kg/m 2 and ≤ 34.9 kg/m 2
• Willingness to accept random assignment to either treatment group.
• Willingness to comply with the follow-up protocol
• Written informed consent.

Exclusion Criteria

• Cardiovascular event (myocardial infarction, acute coronary syndrome, coronary artery angioplasty or bypass, stroke) in the past six months.
• Current evidence of congestive heart failure, angina pectoris, or symptomatic peripheral vascular disease.
• Cardiac stress test indicating that surgery would not be safe.
• Pulmonary embolus or thrombophlebitis in the past six months
• Cancer of any kind (except basal cell skin cancer or cancer in situ) unless documented to be disease-free for five years
• Serum creatinine ≥ 1.5 mg/dl
• History of stomach surgery, bile duct surgery, pancreatic surgery, splenectomy, or colon resection
• Previous organ transplantation.
• History of alcohol or drug dependency
• Current participation in a conflicting research protocol.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LRYGB	LRYGB	20 subjects Randomized will undergo LRYGB surgery
SADJB	SADJB	20 subjects will undergo SADJB surgery
LMGB	LMGB	20 subjects will undergo LMGB surgery

Primary Outcome Measures

Name	Time	Method
Remission of diabetes	two years	remission of Diabetes Mellitus Type 2 after different types of Gastric bypass surgery

Secondary Outcome Measures

Name	Time	Method
weight loss and improvement in quality of life	2 years	weight loss and improvements in quality of life after different types of gastric bypass surgery

Trial Locations

Locations (1)

Min-Sheng General Hospital; 🇨🇳 Taoyuan City, Taiwan