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

Primary Purpose

Coronary Heart Disease, Impaired Glucose Tolerance

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Voglibose tablets
Sponsored by
Ministry of Science and Technology of the People´s Republic of China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Coronary Heart Disease

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Peking University First HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Drug

Arm Description

Placebo with lifestyle intervention

Voglibose tablets with lifestyle intervention

Outcomes

Primary Outcome Measures

TypeⅡDiabetes Mellitus

Secondary Outcome Measures

Occurrence of Cardiovascular Events

Full Information

First Posted
July 25, 2008
Last Updated
August 22, 2008
Sponsor
Ministry of Science and Technology of the People´s Republic of China
Collaborators
Takeda
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1. Study Identification

Unique Protocol Identification Number
NCT00724542
Brief Title
Evaluation of Intervention on Impaired Glucose Tolerance(IGT) in Patients With Coronary Heart Disease.
Acronym
EIIGETPCHD
Official Title
Evaluation of Lifestyle and Therapeutic Intervention on Impaired Glucose Tolerance(IGT) in Patients With Coronary Heart Disease.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2008
Overall Recruitment Status
Unknown status
Study Start Date
July 2008 (undefined)
Primary Completion Date
December 2010 (Anticipated)
Study Completion Date
December 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Ministry of Science and Technology of the People´s Republic of China
Collaborators
Takeda

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Heart Disease, Impaired Glucose Tolerance

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Placebo with lifestyle intervention
Arm Title
Drug
Arm Type
Experimental
Arm Description
Voglibose tablets with lifestyle intervention
Intervention Type
Drug
Intervention Name(s)
Voglibose tablets
Intervention Description
0.2mg Tid
Primary Outcome Measure Information:
Title
TypeⅡDiabetes Mellitus
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Occurrence of Cardiovascular Events
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wenhui Ding, Professor
Phone
86-10-66551122
Ext
5001
Email
dwh_rd@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Libin Shi
Email
shlb1975@yahoo.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wenhui Ding, Professor
Organizational Affiliation
Peking University First Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University First Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100034
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenhui Ding, Professor
Phone
86-10-66551122
Ext
5001
Email
dwh_rd@126.com

12. IPD Sharing Statement

Learn more about this trial

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

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