Proteomics Study of Gastric Bypass Surgery to Treat Type 2 Diabetes Mellitus

Study Overview
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Brief Summary
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The purpose of this study is to reveal the key proteins involved in gastric bypassing surgery which may effect the decreased glucose in type 2 diabetes patietns, and evaluate standard remission rate as well as cost-benefit of gastric bypassing surgery for type 2 diabetes mellitus patients in China.

Detailed Description
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Diabetes Mellitus is a major global problem which responsibles for 4.6 million deaths each year without effective therapy methods. Recently，researchers showed that type 2 diabetes mellitus can be partly reversed by gastric bypassing surgery. However, surgeons are still not clear how to chose the proper diabetes patients for surgery as the mechanism is still not clear, and the remission rate of diabetes mellitus is not the same among different surgical procedures. This study will enroll type 2 diabetes mellitus patients follwing Roux-en-Y gastric bypassing surgery and obese persons without type 2 diabetes surgery. The defferent expressions of serum proteins of obese persons without type 2 diabetes and type 2 diabetes patients following gastric bypassing surgery after 10 days or 3 months were detected by serum proteomics. Blood samples and urine will be taken prior to surgery, 10 days after surgery and 3 months after surgery. The long term prognosis of diabetes mellitus for 1 years and the remission rate of diabetes of patients will be evaluated.

Official Title
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Serum Proteomics Research in Bypassing Surgery to Treat Type 2 Diabetes in China

Conditions
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Type 2 Diabetes

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients diagnosed as type 2 diabetes are planning to have Roux-en-Y gastric bypass age:18-65yr HbAlc>8% Exclusion Criteria: diabetes (applies for control patients) chronic inflammatory disease malignant disease pregnancy prior gastric, duodenal, proximal jejunal surgery or pancreas resection current use of thiazolidinediones treatment with incretin mimetics or DPP IV inhibitors in the prior 3 months HbAlc<8% any condition felt by the investigator to interfere with ability to complete the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| type 2 diabetes patients with gastric bypass surgery.<br>Participants who have type 2 diabetes and with decreased glucose after gastric bypass surgery. | |
| Weight matched non-operated controls<br>Participants who are overweight to moderately obese, and have no personal of family history of Type 1, Type 2, or Gestational Diabetes. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| different proteins detected between obese persons, type 2 diabetes patients prior to surgery, 10 days after surgery and 3 months after surgery. |  | base line to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluating the change in glucose between the baseline evaluation and the follow-up evaluation. |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gastric bypass surgery, proteomics