Prospective Randomized Trials of Gastric Bypass Surgery in Patients With Type II Diabetes Mellitus

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prospective Randomized Trials of Gastric Bypass Surgery in Patients With Type II Diabetes Mellitus

Conditions
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Type II Diabetes Mellitus

Intervention / Treatment
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* Procedure: gastric bypass
* Procedure: sleeve gastrectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 1<br>Medical Group | |
| Active Comparator: 2<br>Surgical Group with gastric bypass | Procedure: gastric bypass<br> <br> |
| Active Comparator: 3<br>Sugical Group with Sleeve gastrectomy | Procedure: sleeve gastrectomy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure sugar levels, HbA1c levels, and medication needed. OGTT, MGTT. |  | 1st, 2nd, 3rd, 4th, 5th, 6th, 9th, 12th months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparing the DM controls between Medical and Surgical treatment In surgery groups, compare the bypass surgery and sleeve gastrectomy |  | 1 yr | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sugar control, Type II Diabetes Mellitus, Gastric bypass, Obese-related diabetes mellitus, treatment of obesity related diabetes mellitus