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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by Third Military Medical University.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Wu Qinan, Third Military Medical University
ClinicalTrials.gov Identifier:
NCT01435980
First received: September 8, 2011
Last updated: September 15, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes
Procedure: Gastric Bypass
Drug: Exenatide
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study of Comparison the Treatment Effect Between Gastric Bypass and Exenatide in Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Third Military Medical University:

Primary Outcome Measures:
  • Clinical events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Participant with stroke or Myocardial infarction or acute diabetic complication or Liver and renal failure or death or other Adverse Events.


Secondary Outcome Measures:
  • echocardiography [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Left ventricular mass index (LVMI)

  • echocardiography [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    relative wall thickness (RWT)

  • Blood testing [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    High-sensitive C-reactive protein (HsCRP)

  • Blood testing [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    homeostasis model assessment(HOMA-IR)

  • Blood testing [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    adiponectin

  • Blood pressure monitoring [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    blood pressure

  • Blood testing [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    glycosylated hemoglobin A1c(HbA1c)


Estimated Enrollment: 60
Study Start Date: February 2008
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: basal treatment
basal treatment
Experimental: Gastric Bypass
basal treatment and Gastric Bypass
Procedure: Gastric Bypass
basal treatment and Gastric Bypass
Other Name: basal treatment + Gastric Bypass
Experimental: Exenatide
basal treatment and Exenatide
Drug: Exenatide
basal treatment and Exenatide
Other Name: basal treatment + 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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01435980

Contacts
Contact: wu qi nan, master 13452867542 ext 02368765216 wqn11@126.com

Locations
China, Chongqing
Endocrine Department, the south west Hospital of the Third Military Medical University Recruiting
Chongqing, Chongqing, China, 400038
Contact: wu qi nan, master    13452867542 ext 02368765216    wqn11@126.com   
Principal Investigator: liang zi wen, doctor         
Sponsors and Collaborators
Wu Qinan
Investigators
Principal Investigator: liang zi wen, doctor Third Military Medical University
  More Information

No publications provided

Responsible Party: Wu Qinan, Third Military Medical University
ClinicalTrials.gov Identifier: NCT01435980     History of Changes
Other Study ID Numbers: the south west Hospital2
Study First Received: September 8, 2011
Last Updated: September 15, 2011
Health Authority: China: Food and Drug Administration

Keywords provided by Third Military Medical University:
type 2 diabetes
Gastric Bypass
GLP-1
adiponectin

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Exenatide
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Hypoglycemic Agents
Incretins
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014