Evaluation of Intervention on Impaired Glucose Tolerance(IGT) in Patients With Coronary Heart Disease. (EIIGETPCHD)

August 22, 2008 updated by: Ministry of Science and Technology of the People´s Republic of China

Evaluation of Lifestyle and Therapeutic Intervention on Impaired Glucose Tolerance(IGT) in Patients With Coronary Heart Disease.

The purpose of this study is to determine whether therapeutic intervention on impaired glucose tolerance in patients with coronary heart disease can decrease the incidence of new onset DM.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

1600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Wenhui Ding, Professor
  • Phone Number: 5001 86-10-66551122
  • Email: dwh_rd@126.com

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100034
        • Recruiting
        • Peking University First Hospital
        • Contact:
          • Wenhui Ding, Professor
          • Phone Number: 5001 86-10-66551122
          • Email: dwh_rd@126.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with coronary heart disease
  • Impaired Glucose Tolerance

Exclusion Criteria:

  • Age < 40yr or > 75yr
  • Diabetes Mellitus
  • Scr > 2.0 mg/dL（176 μmol/L）
  • ALT or AST > 2.5 ULN
  • Hb < 90g/L
  • Heart Failure
  • Infection
  • Undergo other interventional clinical trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Placebo with lifestyle intervention
Experimental: Drug
Voglibose tablets with lifestyle intervention
Drug: Voglibose tablets
0.2mg Tid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
TypeⅡDiabetes Mellitus
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Occurrence of Cardiovascular Events
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ministry of Science and Technology of the People´s Republic of China

Collaborators

Takeda

Investigators

  • Principal Investigator: Wenhui Ding, Professor, Peking University First Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Anticipated)

December 1, 2010

Study Completion (Anticipated)

December 1, 2010

Study Registration Dates

First Submitted

July 25, 2008

First Submitted That Met QC Criteria

July 28, 2008

First Posted (Estimate)

July 29, 2008

Study Record Updates

Last Update Posted (Estimate)

August 25, 2008

Last Update Submitted That Met QC Criteria

August 22, 2008

Last Verified

August 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2006BAI01A02-11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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