Bariatric surgery vs intensive medical therapy in mildly obese Japanese patients with early onset type 2 diabetes mellitus
- Conditions
- Obesity, type 2 diabetes mellitus
- Registration Number
- JPRN-UMIN000038432
- Lead Sponsor
- Weight Loss and Metabolic Surgery Center, Yotsuya Medical Cube
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 60
Not provided
1) Cardiovascular event in the past 6 months. 2) Current evidence of congestive heart failure, angina pectoris, or symptomatic peripheral vascular disease. 3) Cardiac stress test indicating that surgery would not be safe. 4) Pulmonary embolus or thrombophlebitis in the past 6 months. 5) Cancer of any kind unless documented to be disease-free for 5 years. 6) Significant anemia (hemoglobin 1.0 g or more below normal range) or history of coagulopathy. 7) Serum creatinine less than 1.5 mg/dl. 8) Serum total bilirubin greater than the upper limit of normal, or alkaline phosphatase or ALT greater than twice the upper limit of normal. 9) History of stomach surgery, bile duct surgery, pancreatic surgery, splenectomy, or colon resection. 10) Gastric or duodenal ulcer in the past 6 months. 11) History of intra-abdominal sepsis. 12) Self-reported HIV-positive status, active tuberculosis, active malaria, chronic hepatitis B or C, cirrhosis, or inflammatory bowel disease. 13) Currently pregnant or nursing, or planning to become pregnant in the next 2 years. 14) History of alcohol or drug dependency in the past 5 years. 15) Active psychosocial or psychiatric problem that is likely to interfere with adherence to the protocol. 16) Presence of any chronic or debilitating disease that would make adherence to the protocol difficult. 17) 12-lead EKG indicating that surgery would not be safe. 18) Serum fasting c-peptide less than 1.0 ng/ml. 19) Exclusions may also be made at the discretion of the attending physician.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome will be assessed at 1 year, and will be a success rate of patients with HbA1c less than 6.5% without diabetes medication.
- Secondary Outcome Measures
Name Time Method 1. Changes in weight and BMI, waist circumference, HbA1c, fasting glucose, fasting insulin, systolic blood pressure, diastolic blood pressure, lipid profile (serum total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides) 2. Changes in urine microalbumin/creatinine ratio and resolution of co-morbid renal function illness. 3. Use of medications (as measured by dosages and cost) 4. Total cost of diabetes- and CVD-related health care 5. Measures from three surveys: Quality of life (SF-36). The surveys will be collected at the baseline, 6 months, and 12 months. 6. Mortality 7. Cardiovascular events (myocardial infarction, stroke, other serious CVD) 8. Complications from surgery