Type II Diabetes Mellitus
Conditions
Keywords
Type II Diabetes Mellitus, Gastric bypass, Obese-related diabetes mellitus, Sugar control, treatment of obesity related diabetes mellitus
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREgastric bypass
PROCEDUREsleeve gastrectomy
Sponsors
Min-Sheng General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measure sugar levels, HbA1c levels, and medication needed. OGTT, MGTT. | 1st, 2nd, 3rd, 4th, 5th, 6th, 9th, 12th months |
Secondary
| Measure | Time frame |
|---|---|
| Comparing the DM controls between Medical and Surgical treatment In surgery groups, compare the bypass surgery and sleeve gastrectomy | 1 yr |
Countries
Taiwan
Contacts
Primary ContactLee WeiJei, M.D, Ph.D
Outcome results
None listed