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

Wu Qinan

Status and phase: Unknown; Phase 4

Conditions: Type 2 Diabetes

Treatments: Procedure: Gastric Bypass; Drug: Exenatide

Study type: Interventional

Funder types: Other

Identifiers

NCT01435980

the south west Hospital2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

basal treatment

No Intervention group

Description:

basal treatment

Gastric Bypass

Experimental group

Description:

basal treatment and Gastric Bypass

Treatment:

Procedure: Gastric Bypass

Exenatide

Experimental group

Description:

basal treatment and Exenatide

Treatment:

Drug: Exenatide