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

Phase 4

• Conditions: Type 2 Diabetes
• Interventions: Procedure: Gastric Bypass; Drug: Exenatide

• Registration Number: NCT01435980
• Lead Sponsor: Wu Qinan

Brief Summary

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

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.

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2011-09-08
• Study First Submitted QC: 2011-09-15
• Study First Posted: 2011-09-19
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-25
• Last Update Posted: 2015-03-27
• Primary Completion: 2016-01
• Study Completion: 2016-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. BMI ≥ 35kg/m2, With Type 2 Diabetes;
2. BMI32-34.9kg/m2, With Type 2 Diabetes, Insulin Therapy in Combination With Oral Administration of Drugs for 6 Months and HbA1c ≥ 7%;
3. Between the Ages of 18-60 Years;
4. Course of Type 2 Diabetes ≤ 5 Years;
5. ICA, IAA, GAD Are Negative , C-peptide Level is Not Less Than 0.3mg / L;

Exclusion Criteria

1. 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;
2. patients who had liver or renal failure
3. severe infections in patients and patients who had cerebrovascular disease
4. patients who had heart failure
5. fasting serum insulin or 2-hour postprandial serum insulin were lower than normal (<20mmol / L)
6. course of diabetes> 5 years or age> 60 years or age <18 years

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gastric Bypass	Gastric Bypass	basal treatment and Gastric Bypass
Exenatide	Exenatide	basal treatment and Exenatide

Primary Outcome Measures

Name	Time	Method
Clinical events	1 year	Participant with stroke or Myocardial infarction or acute diabetic complication or Liver and renal failure or death or other Adverse Events.

Secondary Outcome Measures

Name	Time	Method
Blood testing	1 year	glycosylated hemoglobin A1c（HbA1c）
Blood pressure monitoring	1 month	blood pressure
echocardiography	1 year	relative wall thickness (RWT)

Trial Locations

Locations (1)

Endocrine Department, the south west Hospital of the Third Military Medical University; 🇨🇳 Chongqing, Chongqing, China