NCT01435980

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for phase_4 type-2-diabetes

Timeline
Completed

Started Feb 2008

Longer than P75 for phase_4 type-2-diabetes

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2011

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 19, 2011

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

March 27, 2015

Status Verified

March 1, 2015

Enrollment Period

7.9 years

First QC Date

September 8, 2011

Last Update Submit

March 25, 2015

Conditions

Type 2 Diabetes

Keywords

type 2 diabetesGastric BypassGLP-1adiponectin

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (7)

  • echocardiography

    1 year

  • echocardiography

    1 year

  • Blood testing

    1 year

  • Blood testing

    1 year

  • Blood testing

    1 year

  • +2 more secondary outcomes

Study Arms (3)

basal treatment

NO INTERVENTION

basal treatment

Gastric Bypass

EXPERIMENTAL

basal treatment and Gastric Bypass

Procedure: Gastric Bypass

Exenatide

EXPERIMENTAL

basal treatment and Exenatide

Drug: Exenatide

Interventions

Gastric BypassPROCEDURE

basal treatment and Gastric Bypass

Also known as: basal treatment + Gastric Bypass
Gastric Bypass
ExenatideDRUG

basal treatment and Exenatide

Also known as: basal treatment + Exenatide
Exenatide

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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;

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Endocrine Department, the south west Hospital of the Third Military Medical University

Chongqing, Chongqing Municipality, 400038, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Gastric BypassExenatide

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Bariatric SurgeryBariatricsObesity ManagementTherapeuticsGastroenterostomyAnastomosis, SurgicalSurgical Procedures, OperativeDigestive System Surgical ProceduresPeptidesAmino Acids, Peptides, and ProteinsVenomsComplex MixturesToxins, BiologicalBiological Factors

Study Officials

  • liang zi wen, doctor

    Third Military Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

wu qi nan, master

CONTACT

13452867542wqn11@126.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Third Military Medical University

Study Record Dates

First Submitted

September 8, 2011

First Posted

September 19, 2011

Study Start

February 1, 2008

Primary Completion

January 1, 2016

Study Completion

February 1, 2016

Last Updated

March 27, 2015

Record last verified: 2015-03

Locations

CN(1)