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Hyperoxic Exercise in Type 2 Diabetes.

Hyperoxic exercise training as an innovative therapy to improve metabolic control, endothelial dysfunction and physical fitness in deconditioned type 2 diabetes patients.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON20199
Enrollment
48
Registered
2010-04-27
Start date
2010-05-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Diabetes type 2

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 inter

Sponsors

Erasmus MC, University Medical Center Rotterdam
Lead Sponsor

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 willing/able to travel 3 times a week to ErasmusMC and participate in a supervised exercise intervention program.

Exclusion criteria

Exclusion criteria: 1. Use of Beta-blocker therapy, low molecular heparin, exogenous insulin therapy (for exercise intervention only), use of oral anti-coagulans therapy; 2. Decompensatio cordis, angina pectoris, myocardial infarction or positive signs of cardiac ischaemia on the ECG during the incremental exercise test; 3. Orthopaedic impairments that would limit participation in the training program; 4. Co-morbidity such as renal failure or > grade III retinopathy or previous diabetic foot ulcer; 5. Cerebro-vascular disease (CVA), neurological diseases or deficits; 6. A history of glaucoma or high intraocular pressure will be contraindication for dilated fundus reflex photography.

Design outcomes

Primary

MeasureTime frame
The relative improvement in whole-body insulin sensitivity. An insulin sensitivity index (SI) will be calculated by using the minimal model (Bergman et al 1985); a higher SI indicates enhanced insulin sensitivity. Acute-phase insulin secretion (AIRG) and glucose effectiveness (SG) were also determined from the IVGTT ( Bergman et al 1985).

Secondary

MeasureTime frame
1. Relative improvements in vascular function parameters using forearm plethysmography (change in forearmbloodflow in ml/100g forearm/min after nitriprusside/acetylcholine); 2. Cardiovascular fitness (VO2max); 3. Systemic blood pressure; 4. Body composition; 5. Lipid metabolism; 6. Glycemic control. In 12 subjects from the control group and 12 subjects from the intervention group: GLUT-4 expression in the muscle, mitochondrial enzymatic activity and muscle fiber morphologic characteristics from muscle biopsy analysis.

Contacts

Public ContactD. Visser

P.O. box 2040

d.visser.1@erasmusmc.nl+31 (0)10 7031679

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)