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DIAbetes-PREvention Trial.


- candidate number9469
- NTR NumberNTR2920
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR24-mei-2011
- Secondary IDsNL37115.075.11 CCMO
- Public TitleDIAbetes-PREvention Trial.
- Scientific TitleDIAbetes-PREvention Trial.
- ACRONYMDiaPreT
- hypothesisThis 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.
- Healt Condition(s) or Problem(s) studiedDiabetes Mellitus, Coronary artery disease, ST-segment elevation myocardial infarction (STEMI), Non ST segment elevation mycardiac ischemia, PCI or CABG in stable CAD
- Inclusion criteria1. 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.
- Exclusion criteria1. 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.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingTriple
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mrt-2012
- planned closingdate1-dec-2013
- Target number of participants78
- InterventionsTo 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.
- Primary outcomeA 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.
- Secondary outcome1. hsCRP;
2. LDL cholesterol;
3. MACE at one year FUP;
4. Exercise capacity.
- TimepointsAll subjects will require follow-up visits to our hospital at 6 months and 12 months (Ī 30 days) after the index myocardial infarction.
- Trial web siteN/A
- statusstopped
- CONTACT FOR PUBLIC QUERIES Sonja Postma
- CONTACT for SCIENTIFIC QUERIESMD. PhD. A.W.J. Hof, van 't
- Sponsor/Initiator Isala Clinics Zwolle
- Funding
(Source(s) of Monetary or Material Support)
Isala Klinieken
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)31-3-2014: Vroegtijdige beŽindiging studie. - AB
- RECORD24-mei-2011 - 31-mrt-2014


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