| Registry | NCT00540462, acronym T2DM |
|---|---|
| Status | Unknown |
| Phase | Phase 4 |
| Study type | Interventional; randomized, parallel, masking: triple, treatment |
| Enrollment | 120 (Estimated) |
| Sponsor | Min-Sheng General Hospital (Other) |
| Conditions | Type II Diabetes Mellitus |
| Interventions | gastric bypass, sleeve gastrectomy (Procedure) |
| Dates | start 2007-08-01, primary completion 2008-08-01 (estimated), completion 2008-12-01 (estimated), first posted 2007-10-08, last updated 2008-11-14 |
| Locations | 1 site in Taiwan |
Related Papers Related Patents Related Grants Related Experts
All trials for Type II Diabetes Mellitus All trials of gastric bypass All trials of sleeve gastrectomy
Although intensive medical treatment of diabetes has clearly been demonstrated to be worthwhile, it has not been a total success in diabetes treatment for a variety of reasons including lack of response to medication. Diabetes has been well demonstrated as a co-morbidity illness of obesity patients. In observation, with exclusion stomach and duodenum of bariatric surgery (gastric bypass), most morbidly obese patients (about 80%) with diabetes had a significant improved of sugar control. Base of this observation, we will try to find out the role surgical intervention (gastric bypass \& sleeve gastrectomy) in obese-related diabetes.
In observation, with exclusion stomach and duodenum of bariatric surgery (gastric bypass), most morbidly obese patients (about 80%) with diabetes had a significant improved of sugar control. Base on this observation, we will try to find out the role surgical intervention (gastric bypass and sleeve gastrectomy) in obese-related diabetes. With restriction of stomach volume and with or without duodenal exclusion, this randomized trials will find out the role of duodenal exclusion and the role of Ghrenin in obese-related type II DM patients. The initial observation of previous morbidly obese patients with type II DM, the DM seems a chronic disease which could be treated or controlled by surgical intervention, that's what we try to know more.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| 1 | No intervention | Medical Group | |
| 2 | Active comparator | Procedure: gastric bypass | Surgical Group with gastric bypass |
| 3 | Active comparator | Procedure: sleeve gastrectomy | Sugical Group with Sleeve gastrectomy |
Sex: All, ages: 30 Years to 60 Years
Inclusion Criteria: * Patient with diagnosis of T2DM for at least 6 months * Mild to moderate obesity status(BMI 27 - 35 ) * Age : 30 - 60 year-old * HbA1C > 8 % Exclusion Criteria: * With co-morbidity illness of cardiovascular system * DM related nephropathy (Cre >2.0 mg/dl) * Pulmonary embolism or uncontrolled coagulopathy in 6 months * HBV or HCV hepatitis or liver cirrhosis, inflammatory colon disease, Cushing syndrome * s/p organ transplantation * Previously Bariatric surgery, gastrointestinal surgery, or abdominal sepsis * Alcoholic or drug abuser * Psychological disease. * HIV or TB patient
| Facility | City | Country | Status |
|---|---|---|---|
| MinSheng Genral Hospital | Taoyuan | Taiwan | Recruiting |