Asian type 2 diabetics with BMI from 27.5 kg/m2 to 34.9 kg/m2
Conditions
Interventions
Laparoscopic sleeve gastrectomy with duodenal jejunal bypass
Sponsors
Weight Loss and Metabolic Surgery Center Yotsuya Medical Cube
National Center for Global Health and Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Age 20 to 65 years at eligibility visit. (2) Diagnosed with T2DM at least 6 months prior to enrollment, under the active care of a doctor for at least the 6 months prior to enrollment. (4)HbA1c equal to or more than 8.0% at eligibility visit. (4) 27.5 kg/m2<Body Mass Index (BMI) <34.9 kg/m2 at eligibility visit. (5) Willingness to comply with the follow-up protocol. (5) 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 composite of parameters of optimal diabetes management: glycosylated hemoglobin (HbA1c) < 7.0%, fasting LDL cholesterol < 100 mg/dl and systolic blood pressure < 130 mmHg. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcomes will be assessed 1 year after the intervention begins. 1. Changes in weight and BMI, waist circumference, fasting glucose, fasting insulin, lipid profile (serum total 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), depression (CES-D), and a brief version Questionnaire for Eating and Weight Patterns-Revised (QEWP-R) to assess binge eating disorder. 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 ContactSeki Yosuke
Yotsuya Medical Cube Weight Loss and Metabolic Surgery Center
Outcome results
None listed