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DIAbetes-PREvention Trial.

DIAbetes-PREvention Trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON21355
Enrollment
78
Registered
2011-05-24
Start date
2012-03-01
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary artery disease (CAD): PCI or CABG in stable CAD, or post STEMI and post non-STEMI, Cardiac rehabilitation , Diabetes Mellitus

Interventions

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 &#8805
7.0mmol/l or HbA1c &#8805
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:

Sponsors

Isala Klinieken, te Zwolle Maatschap Cardiologie, Interne en sportgeneeskunde, Isala Klinieken.
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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 &#8805; 7.0mmol/l or HbA1c &#8805; 53.

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
1. hsCRP; 2. LDL cholesterol; 3. MACE at one year FUP; 4. Exercise capacity.

Contacts

Public ContactSonja Postma

Dokter Stolteweg 96

s.postma@diagram-zwolle.nl+31 (0)38 4262999

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)