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

Min-Sheng General Hospital

Status: Unknown

Conditions: Diabetes Mellitus Type 2 in Obese

Treatments: Procedure: LRYGB; Procedure: SADJB; Procedure: LMGB

Study type: Interventional

Funder types: Other

Identifiers

NCT01989988

MSIRB2013003 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 20 to 67 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 3 patient groups

LRYGB

Active Comparator group

Description:

20 subjects Randomized will undergo LRYGB surgery

Treatment:

Procedure: LRYGB

SADJB

Active Comparator group

Description:

20 subjects will undergo SADJB surgery

Treatment:

Procedure: SADJB

LMGB

Active Comparator group

Description:

20 subjects will undergo LMGB surgery

Treatment:

Procedure: LMGB