Prospective Observatonal Study for Effect of Duodenojejunal Bypass and Gastric Bypass on T2DM Patients

Study Overview
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Brief Summary
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Surgical treatment for type 2 diabetes has been taken note especially in less obese or non obese patients. In Asian, the nuber of less obses or non obese patients with T2DM is greater than that of the obese. We are trying to do a prospective observational study for the evaluation of the effect of duidenojejunal bypass and gastric bypass on the glycemoc control in those patients. The selection criteria are type 2 diabetess, 20-60 years old, BMI 23-34 or 21-22 with viceral obesity, insulin use less than 10 years and the patients understanding the hypothesis of this study, risks, expecting effects and agreeing this study. We are checking oral GTT, insulin level, C-peptide level, HbA1C, etc. with some anthropometric measurs preoperatively, postoperatively, at 3 month and 12 month. We will compare the clinical factors at each time.

Official Title
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Metabolic Surgery for Type 2 Diabetes

Conditions
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Non Insulin Dependent Diabetes Mellitus

Intervention / Treatment
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* Procedure: laparoscopic roux en Y gastric bypass / open duodenojejunal bypass


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: type 2 diabetes HbA1C > 7.0% BMI 23 - 34 or BMI 21-22 with viceral obesity insulin use less than 10 years uncerstanding the risks, hypothesis, expecting effects Exclusion Criteria: type 1 diabetes C-peptide < 1.0ng/ml BMI < 21 severe cardiovascular diseases or their history malignancy or history alcoholics, pituitary failrue history of severe ketosis, diabetic coma or precoma abnormal liver enzyme, over 3 fold of normal level liver cirrhosis or hepatitis serum creatinine > 2.0mg/dL glucocorticoids user diabetes due to other endocrine diseases pancreatic disease anti-GAD Ab (+) the incongruity for surgery

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: gastric bypass, duodenojejunal bypass<br> | Procedure: laparoscopic roux en Y gastric bypass / open duodenojejunal bypass<br>* routine GBP with 80cm roux and biliopancreatic limb<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin A1C | change of the level | preoperatively, at 3month, at 12 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| oral glucose tolerance test | changes of the level at each time | preopertively, postoperatively, at 3 month, at 12 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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metabolic surgery, gastric bypass, duodenojejunal bypass, type 2 DM