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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01435980
• Other study ID #: the south west Hospital2
• Status: Recruiting
• Phase: Phase 4
• First received: September 8, 2011
• Last updated: March 25, 2015
• Start date: February 2008
• Est. completion date: February 2016

Study information

• Verified date: March 2015
• Source: Third Military Medical University
• Contact: wu qi nan, master
• Phone: 13452867542
• Email: wqn11[@]126.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: February 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Procedure:
• Gastric Bypass
basal treatment and Gastric Bypass

Drug:
• Exenatide
basal treatment and Exenatide

Locations

Country	Name	City	State
China	Endocrine Department, the south west Hospital of the Third Military Medical University	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Wu Qinan

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	echocardiography	Left ventricular mass index (LVMI)	1 year	No
Secondary	echocardiography	relative wall thickness (RWT)	1 year	No
Secondary	Blood testing	High-sensitive C-reactive protein (HsCRP)	1 year	No
Secondary	Blood testing	homeostasis model assessment(HOMA-IR)	1 year	No
Secondary	Blood testing	adiponectin	1 year	No
Secondary	Blood pressure monitoring	blood pressure	1 month	No
Secondary	Blood testing	glycosylated hemoglobin A1c(HbA1c)	1 year	No