diabetes mellitus type 2
Conditions
Interventions
In case of an abnormal stress-ECG during a symptom-limited exercise test, more extensive cardiovascular screening (stress single-photon emission computed tomography (SPECT) myocardial perfusion imagin
Sponsors
Erasmus MC, University Medical Center Rotterdam
Eligibility
Inclusion criteria
Inclusion criteria: 1. Type 2 diabetes > 5 years; 2. Signs of 3 or more diabetes¨Crelated co-morbidities (history of sensori-motor or autonomic neuropathy,retinopathy (gr II or higher), micro-albuminuria, coronary artery disease, transient ischaemic attack, intermittent claudication/peripheral artery disease); 3. HbA1c: 7.0- 10.0%; 4. Age: 45-75 yrs; 5. BMI > 27kg/m2; 6. Sedentary behaviour (i.e. <30 min/day moderately active assessed by activity monitoring); 7. Agreement to volunteer for the study by giving a written informed consent.
Exclusion criteria
Exclusion criteria: 1. Cardio-vascular disease, recent (< 3 m) decompensatio cordis, recent (3 m) unstabile angina pectoris, recent (< 3 m) myocardial infarction, significant cardiac ischaemia during SPECT myocardial perfusion imaging, heartfailure (EF<40% or NYHA class 3 or 4); 2. Severe orthopaedic impairments that would prohibit participation in the training program (eg diabetes ulcers of the foot, amputations); 3. Cerebro-vascular disease (CVA) or other neurological diseases or deficits that would prohibit participation in the training program (eg spasticity).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure evaluates the clinical efficacy of the intervention on the standard diabetes outcome parameter for glycemic control (HbA1c). | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary diabetes related outcome measures evaluate the overall effect on health: 1. Risk profile for cardiovascular disease (lipid profile, arterial blood pressure, heart rate variability); 2. Body composition (BMI, waist circumference, regional fat distribution); 3. Cardiorespiratory fitness (VO2peak); 4. Left ventrical diastolic function (echocardiography); 5. Functional capacity and muscle strength; 6. Health-related quality of life (SF-36); 7. Level of depressive symptoms using the Centre for Epidemiologic Studies Depression Scale (CES-D); 8. Diabetes symptom distress (using the revised version of the Type 2 Diabetes Symptom Checklist). | — |
Contacts
Public ContactD. Visser
P.O. box 2040
Outcome results
None listed