Obesity, type 2 diabetes mellitus
Conditions
Interventions
Laparoscopic sleeve gastrectomy with duodenojejunal bypass (LSG-DJB)
Best medical management focusing on lifestyle modification and pharmacologic treatment
Sponsors
Weight Loss and Metabolic Surgery Center, Yotsuya Medical Cube
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Diagnosed with T2DM at the age of younger than 40 years old. 2) Under the active care of a doctor for at least 6 months prior to enrollment, and HbA1c more than 8%.0 % < HbA1c. 3) Duration of T2DM less than 10 years from diagnosis. 4) BMI 27.5-34.9 kg/m2 at eligibility visit. 5) Willingness to accept random assignment to either treatment group. 6) Willingness to comply with the follow-up protocol. 7) Written informed consent.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactYosuke Seki
Yotsuya Medical Cube Weight Loss and Metabolic Surgery Center
Outcome results
None listed