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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Diabetes Mellitus Type 2 in Obese

Intervention / Treatment
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* Procedure: LMGB
* Procedure: LRYGB
* Procedure: SADJB


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 67 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: LRYGB<br>20 subjects Randomized will undergo LRYGB surgery | Procedure: LRYGB<br> <br> |
| Active Comparator: SADJB<br>20 subjects will undergo SADJB surgery | Procedure: SADJB<br> <br> |
| Active Comparator: LMGB<br>20 subjects will undergo LMGB surgery | Procedure: LMGB<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Remission of diabetes | remission of Diabetes Mellitus Type 2 after different types of Gastric bypass surgery | two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight loss and improvement in quality of life | weight loss and improvements in quality of life after different types of gastric bypass surgery | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 Diabetes Mellitus (T2DM), Obesity, Laparoscopic gastric bypass, Duodenum exclusion