The primary objective of this randomized trial is to reduce the HbA1c levels by 10% through exercise training with or without oral anti-diabetic medication in patients with coronary artery disease (PCI or CABG in stable CAD, or post STEMI and post…
ID
Source
Brief title
Condition
- Other condition
- Coronary artery disorders
Synonym
Health condition
pre-diabetici
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The reduction in HbA1c at one year in patients with coronary artery disease
(PCI or CABG in stable CAD, or post STEMI and post non-STEMI patients)
Secondary outcome
- hsCRP
- LDL cholesterol
- MACE at one year FUP
- Exercise capacity
Background summary
Not only the incidence of diabetes is increasing, but also the incidence of
pre-diabetes, defined as an impaired glucose tolerance test or impaired fasting
glucose. A recent study showed that in China almost 140 million people have
pre-diabetes, more than 15% of the total adult population. The incidence
depends on the definition of pre-diabetes. Other investigators have defined
pre-diabetes based on the HbA1c level. The rise in prevalence of pre-diabetes
is associated with the increase in obesity and physical inactivity. Intense
exercise has been shown to reduce the HbA1c level in patients with diabetes. In
addition, oral anti-diabetic agents have been shown to be effective in patients
with pre-diabetes.
Study objective
The primary objective of this randomized trial is to reduce the HbA1c levels by
10% through exercise training with or without oral anti-diabetic medication in
patients with coronary artery disease (PCI or CABG in stable CAD, or post STEMI
and post non-STEMI patients) that have pre-diabetes.
Study design
Patients who meet the inclusion criteria and non of the exclusion criteria will
be randomized in a 1:1:1 fashion to an exercise training programme, an exercise
training programme in combination with oral anti-diabetic medication
(Metformine) during 1 year or regular treatment (6 weeks).
Intervention
Patients participating in this trial will be followed-up at 6 and 12 months
after admission. Data regarding patient*s history and current health status at
follow-up will be collected and entered into the database by the investigator.
Study burden and risks
All subjects will require follow-up visits to our hospital at 6 and 12 month (±
30 days) after the index myocardial infarction. Subjects will undergo screening
of cardio vascular complications or death, hospitalisation and concomitant
medication.
The study medication for patients randomized to the treatment group: *Exercise
training and Oral anti-diabetic medication*, consists oral Metformine.
Groot Wezenland 20
Zwolle 8011 JW
NL
Groot Wezenland 20
Zwolle 8011 JW
NL
Listed location countries
Age
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
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2011-002469-39-NL |
| CCMO | NL37115.075.11 |
| OMON | NL-OMON21355 |