Diabetes-Prevention Trial

• Conditions: Patients who are candidates for cardiac rehabilitation after documented coronairy artery disease (PCI or CABG in stable CAD, or post STEMI and post non-STEMI), who have pre-diabetes; MedDRA version: 14.1Level: LLTClassification code 10064346Term: STEMISystem Organ Class: 100000004849; MedDRA version: 14.1Level: LLTClassification code 10036482Term: Pre-diabeticSystem Organ Class: 100000004861; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2011-002469-39-NL
• Lead Sponsor: Isala Klinieken

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06-01
• Last Update Posted: 14 April 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion criteria
••Patients admitted with coronairy artery disease (PCI or CABG in stable CAD, or post STEMI and post non-STEMI) (inclusion within 2 month after admission)
•Age = 18 years
•Elevated HbA1c levels (HbA1c > 5.8% or > 40 mmol/mol) on admission
•Access to a computer with internet connection
•Written informed consent

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 39
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 39

Exclusion Criteria

Exclusion criteria
•Known diabetics, with or without anti-diabetic medication
•Contra-indications for Metformine use as stated in the medication registration
•Life Expectancy <1 yr
•Physical limitations/restrictions for participation in exercise programme or exercise testing
•Fasting plasma glucose = 7.0 mmol/l or HbA1c = 53

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this randomized trial is to reduce the HbA1c levels by 10% through an exercise programme with or without oral anti-diabetic medication in patients with coronairy artery disease (PCI or CABG in stable CAD, or post STEMI and post non-STEMI), that have pre-diabetes. <br><br>Primary endpoint<br>- The reduction in HbA1c at one year in patients with coronairy artery disease (PCI or CABG in stable CAD, or post STEMI and post non-STEMI) that have pre-diabetes.<br>;Secondary Objective: Secondary endpoint<br>- hsCRP <br>- LDL cholesterol <br>- MACE at one year FUP <br>- Exercise capacity<br>;Primary end point(s): The reduction in HbA1c at one year in patients with coronairy artery disease (PCI or CABG in stable CAD, or post STEMI and post non-STEMI) that have pre-diabetes. ;Timepoint(s) of evaluation of this end point: one year post admission

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - hsCRP <br>- LDL cholesterol <br>- MACE at one year FUP <br>- Exercise capacity<br>;Timepoint(s) of evaluation of this end point: in-hospital, 6 months follow up and 1 year follow up