Clinical trial NCT01435980: Study of Comparison the Treatment Effect Between Gastric Bypass and Exenatide in Type 2 Diabetes
Official title: Study of Comparison the Treatment Effect Between Gastric Bypass and Exenatide in Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Type 2 Diabetes
Keywords: type 2 diabetes
Gastric Bypass
GLP-1
adiponectin
Lead sponsor: Third Military Medical University
Sponsor class: OTHER
First posted: 2011-09-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Clinical events
timeFrame: 1 year
Secondary outcomes:
measure: echocardiography
timeFrame: 1 year
measure: echocardiography
timeFrame: 1 year
measure: Blood testing
timeFrame: 1 year
measure: Blood testing
timeFrame: 1 year
measure: Blood testing
timeFrame: 1 year
measure: Blood pressure monitoring
timeFrame: 1 month
measure: Blood testing
timeFrame: 1 year
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Endocrine Department, the south west Hospital of the Third Military Medical University
state: Chongqing
Study officials:
affiliation: Third Military Medical University
name: liang zi wen, doctor
role: PRINCIPAL_INVESTIGATOR
References: