This study evaluates the beneficial effects of exercise training with or without oral anti-diabetic medication in patients with coronary artery disease (CAD): PCI or CABG in stable CAD, or post STEMI and post non-STEMI patients who have pre-diabetes.
ID
Bron
Verkorte titel
Aandoening
Coronary artery disease (CAD): PCI or CABG in stable CAD, or post STEMI and post non-STEMI, Cardiac rehabilitation , Diabetes Mellitus
Ondersteuning
Maatschap Cardiologie, Interne en sportgeneeskunde, Isala Klinieken.
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
A 10% 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) that have pre-diabetes.
Achtergrond van het onderzoek
N/A
Doel van het onderzoek
This study evaluates the beneficial effects of exercise training with or without oral anti-diabetic medication in patients with coronary artery disease (CAD): PCI or CABG in stable CAD, or post STEMI and post non-STEMI patients who have pre-diabetes.
Onderzoeksopzet
All subjects will require follow-up visits to our hospital at 6 months and 12 months (± 30 days) after the index myocardial infarction.
Onderzoeksproduct en/of interventie
To exclude new diabetics, a fasting plasma glucose will be measured in each patient that meets the inclusion criteria. Patients with a fasting plasma glucose ≥ 7.0mmol/l or HbA1c ≥ 53 will be referred for further treatment of their diabetes and will not be included in the trial. 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.
Publiek
Sonja Postma
Zwolle 8025 AZ
The Netherlands
+31 (0)38 4262999
s.postma@diagram-zwolle.nl
Wetenschappelijk
Sonja Postma
Zwolle 8025 AZ
The Netherlands
+31 (0)38 4262999
s.postma@diagram-zwolle.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Pcoronary artery disease (CAD): PCI or CABG in stable CAD, or post STEMI and post non-STEMI (inclusion within 2 month after admission);
2. Age ≥ 18 years;
3. Elevated HbA1c levels (HbA1c > 5.8% or > 40 mmol/mol) on admission;
4. Access to a computer with internet connection;
5. Written informed consent.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Known diabetics, with or without anti-diabetic medication;
2. Contra-indications for Metformine use as stated in the medication registration;
3. Life Expectancy <1 yr;
4. Physical limitations/restrictions for participation in exercise programme or exercise testing;
5. Fasting plasma glucose ≥ 7.0mmol/l or HbA1c ≥ 53.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL2780 |
| NTR-old | NTR2920 |
| CCMO | NL37115.075.11 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON38088 |