Diabetes mellitus type 2
Conditions
Interventions
After inclusion, 12 patients will participate in the dosefinding study (substudy 1). The remaining 36 subjects will be randomised and blinded to 16 weeks of progressive 30-45 min cycle ergometer inte
Sponsors
Erasmus MC
P.O.Box 2040, NL-3000 CA Rotterdam
phone: +31 10 703 18 87 / 31 80 (secr)
Eligibility
Inclusion criteria
Inclusion criteria: 1. Type 2 diabetes according to WHO criteria for over 2 years; 2. VO2peak 60-90% of age-predicted value as measured on a cycle-ergometer; 3. Motivated and willling/able to travel 3 times a week to Erasmus MC and participate in a supervised exercise intervention program.
Exclusion criteria
Exclusion criteria: 1. Use of ß-blocker therapy; 2. Exogenous insulin therapy (for substudy 2 only); 3. Use of oral anti-coagulans therapy/low molecular heparin; 4. Decompensatio cordis, angina pectoris, myocardial infarction or positive signs of cardiac ischaemia on the ECG during the incremental exercise test; 5. Orthopaedic impairments that would limit participation in the training program; 6. Co-morbidity such as renal failure or >grade III retinopathy or previous diabetic foot ulcer; 7. Cerebro-vascular disease (CVA), neurological diseases or deficits; 8. A history of glaucoma or high intraocular pressure will be contraindication for dilated fundus reflex photography).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main study parameters/endpoints: The main study parameter and end-point is the relative improvement in whole-body insulin sensitivity. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end-points are relative improvements in vascular function parameters using forearm plethysmography, cardiovascular fitness, systemic blood pressure, body composition, lipid metabolism and glycemic control. | — |
Contacts
Public ContactS.F.E. Praet
Dept. of Rehabilitation Medicine Erasmus MC, room H-021 P.O.Box 2040
Outcome results
None listed