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

Sponsor

Min-Sheng General Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT01989988

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus Type 2 in Obese	Procedure: LMGB Procedure: LRYGB Procedure: SADJB	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2013

Anticipated Primary Completion Date :

Jul 1, 2015

Anticipated Study Completion Date :

Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: LRYGB 20 subjects Randomized will undergo LRYGB surgery	Procedure: LRYGB
Active Comparator: SADJB 20 subjects will undergo SADJB surgery	Procedure: SADJB
Active Comparator: LMGB 20 subjects will undergo LMGB surgery	Procedure: LMGB

Arm

Intervention/Treatment

Active Comparator: LRYGB

20 subjects Randomized will undergo LRYGB surgery

Procedure: LRYGB

Active Comparator: SADJB

20 subjects will undergo SADJB surgery

Procedure: SADJB

Active Comparator: LMGB

20 subjects will undergo LMGB surgery

Procedure: LMGB

Outcome Measures

Primary Outcome Measures

Remission of diabetes [two years]
remission of Diabetes Mellitus Type 2 after different types of Gastric bypass surgery

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 67 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.