search
Back to results

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

Primary Purpose

Type 2 Diabetes

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Gastric Bypass
Exenatide
Sponsored by
Wu Qinan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring type 2 diabetes, Gastric Bypass, GLP-1, adiponectin

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Endocrine Department, the south west Hospital of the Third Military Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

basal treatment

Gastric Bypass

Exenatide

Arm Description

basal treatment

basal treatment and Gastric Bypass

basal treatment and Exenatide

Outcomes

Primary Outcome Measures

Clinical events
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
Left ventricular mass index (LVMI)
echocardiography
relative wall thickness (RWT)
Blood testing
High-sensitive C-reactive protein (HsCRP)
Blood testing
homeostasis model assessment(HOMA-IR)
Blood testing
adiponectin
Blood pressure monitoring
blood pressure
Blood testing
glycosylated hemoglobin A1c(HbA1c)

Full Information

First Posted
September 8, 2011
Last Updated
March 25, 2015
Sponsor
Wu Qinan
search

1. Study Identification

Unique Protocol Identification Number
NCT01435980
Brief Title
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

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Unknown status
Study Start Date
February 2008 (undefined)
Primary Completion Date
January 2016 (Anticipated)
Study Completion Date
February 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Wu Qinan

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
type 2 diabetes, Gastric Bypass, GLP-1, adiponectin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
basal treatment
Arm Type
No Intervention
Arm Description
basal treatment
Arm Title
Gastric Bypass
Arm Type
Experimental
Arm Description
basal treatment and Gastric Bypass
Arm Title
Exenatide
Arm Type
Experimental
Arm Description
basal treatment and Exenatide
Intervention Type
Procedure
Intervention Name(s)
Gastric Bypass
Other Intervention Name(s)
basal treatment + Gastric Bypass
Intervention Description
basal treatment and Gastric Bypass
Intervention Type
Drug
Intervention Name(s)
Exenatide
Other Intervention Name(s)
basal treatment + Exenatide
Intervention Description
basal treatment and Exenatide
Primary Outcome Measure Information:
Title
Clinical events
Description
Participant with stroke or Myocardial infarction or acute diabetic complication or Liver and renal failure or death or other Adverse Events.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
echocardiography
Description
Left ventricular mass index (LVMI)
Time Frame
1 year
Title
echocardiography
Description
relative wall thickness (RWT)
Time Frame
1 year
Title
Blood testing
Description
High-sensitive C-reactive protein (HsCRP)
Time Frame
1 year
Title
Blood testing
Description
homeostasis model assessment(HOMA-IR)
Time Frame
1 year
Title
Blood testing
Description
adiponectin
Time Frame
1 year
Title
Blood pressure monitoring
Description
blood pressure
Time Frame
1 month
Title
Blood testing
Description
glycosylated hemoglobin A1c(HbA1c)
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: BMI ≥ 35kg/m2, With Type 2 Diabetes; BMI32-34.9kg/m2, With Type 2 Diabetes, Insulin Therapy in Combination With Oral Administration of Drugs for 6 Months and HbA1c ≥ 7%; Between the Ages of 18-60 Years; Course of Type 2 Diabetes ≤ 5 Years; ICA, IAA, GAD Are Negative , C-peptide Level is Not Less Than 0.3mg / L; Exclusion Criteria: 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; patients who had liver or renal failure severe infections in patients and patients who had cerebrovascular disease patients who had heart failure fasting serum insulin or 2-hour postprandial serum insulin were lower than normal (<20mmol / L) course of diabetes> 5 years or age> 60 years or age <18 years
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
wu qi nan, master
Phone
13452867542
Ext
02368765216
Email
wqn11@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
liang zi wen, doctor
Organizational Affiliation
Third Military Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Endocrine Department, the south west Hospital of the Third Military Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400038
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
wu qi nan, master
Phone
13452867542
Ext
02368765216
Email
wqn11@126.com
First Name & Middle Initial & Last Name & Degree
liang zi wen, doctor

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs