Study of Comparison the Treatment Effect Between Gastric Bypass and Exenatide in Type 2 Diabetes

Study Overview
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Brief Summary
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Objectives: To investigate the treatment effect between Gastric Bypass and Exenatide in Type 2 Diabetes in our hospital, in order to investigate the possible mechanism of Gastric Bypass and Exenatide.

Detailed Description
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Methods: 60 Type 2 diabetes in our hospital will divide into 3 groups: group A (20 patients who give basal treatment), group B (20 patients who give basal and Exenatide treatment, group C（20 patients who give basal and Gastric Bypass treatment). The age, height, weight, blood glucose, glycosylated hemoglobin A1c（HbA1c）,homeostasis model assessment(HOMA-IR), lipid, blood pressure, course of disease, ejection fraction (EF), fractional shortening(FS), diameter of left ventricle in late diastolic stage(LVEDd), the thickness of the ventricular septa（IVSD) and the posterior wall of the right ventricle in late diastolic stage (LVPWd) will record respectively. Left ventricular mass index (LVMI), relative wall thickness (RWT) will calculate and High-sensitive C-reactive protein (HsCRP), adiponectin and Tumor necrosis factor-α（TNF-α） will detect as Baseline. After each group's treatment, Change from baseline of all indexes will record, Multifactor logistic regression will be analyzed the correlations between each positive indexes.

Official Title
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Study of Comparison the Treatment Effect Between Gastric Bypass and Exenatide in Type 2 Diabetes

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Procedure: Gastric Bypass
* Drug: Exenatide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI ≥ 35kg/m2, With Type 2 Diabetes; BMI32-34.9kg/m2, With Type 2 Diabetes, Insulin Therapy in Combination With Oral Administration of Drugs for 6 Months and HbA1c ≥ 7%; Between the Ages of 18-60 Years; Course of Type 2 Diabetes ≤ 5 Years; ICA, IAA, GAD Are Negative , C-peptide Level is Not Less Than 0.3mg / L; Exclusion Criteria: non-diabetic patients , type 1 diabetes (serum insulin antibodies (ICA) or glutamic acid decarboxylase antibodies (GADA)-positive autoimmune diabetes), special type of diabetes, gestational diabetes; patients who had liver or renal failure severe infections in patients and patients who had cerebrovascular disease patients who had heart failure fasting serum insulin or 2-hour postprandial serum insulin were lower than normal (<20mmol / L) course of diabetes> 5 years or age> 60 years or age <18 years

Ages Eligible for Study
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Minimum Age: 18 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: basal treatment<br>basal treatment | |
| Experimental: Gastric Bypass<br>basal treatment and Gastric Bypass | Procedure: Gastric Bypass<br>* basal treatment and Gastric Bypass<br>* Other names: basal treatment + Gastric Bypass;|
| Experimental: Exenatide<br>basal treatment and Exenatide | Drug: Exenatide<br>* basal treatment and Exenatide<br>* Other names: basal treatment + Exenatide;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical events | Participant with stroke or Myocardial infarction or acute diabetic complication or Liver and renal failure or death or other Adverse Events. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| echocardiography | Left ventricular mass index (LVMI) | 1 year | 
| echocardiography | relative wall thickness (RWT) | 1 year | 
| Blood testing | High-sensitive C-reactive protein (HsCRP) | 1 year | 
| Blood testing | homeostasis model assessment(HOMA-IR) | 1 year | 
| Blood testing | adiponectin | 1 year | 
| Blood pressure monitoring | blood pressure | 1 month | 
| Blood testing | glycosylated hemoglobin A1c（HbA1c） | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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type 2 diabetes, Gastric Bypass, GLP-1, adiponectin