Diabetes Mellitus Type 2 in Obese
Conditions
Keywords
Type 2 Diabetes Mellitus (T2DM), Obesity, Laparoscopic gastric bypass, Duodenum exclusion
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.
Interventions
Sponsors
Min-Sheng General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to 67 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Remission of diabetes | two years | remission of Diabetes Mellitus Type 2 after different types of Gastric bypass surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Taiwan
Outcome results
None listed