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

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01435980
Enrollment
60
Registered
2011-09-19
Start date
2008-02-29
Completion date
2016-02-29
Last updated
2015-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Keywords

type 2 diabetes, Gastric Bypass, GLP-1, adiponectin

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.

Interventions

PROCEDUREGastric Bypass

basal treatment and Gastric Bypass

DRUGExenatide

basal treatment and Exenatide

Sponsors

Wu Qinan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Clinical events1 yearParticipant with stroke or Myocardial infarction or acute diabetic complication or Liver and renal failure or death or other Adverse Events.

Secondary

MeasureTime frameDescription
echocardiography1 yearLeft ventricular mass index (LVMI)
Blood testing1 yearHigh-sensitive C-reactive protein (HsCRP)
Blood pressure monitoring1 monthblood pressure

Countries

China

Contacts

Primary Contactwu qi nan, master
wqn11@126.com13452867542

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026