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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON33119
Enrollment
48
Registered
2009-04-03
Start date
2009-10-22
Completion date
Unknown
Last updated
2024-05-06

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

Conditions

adult onset diabetes Diabetes type 2

Interventions

After inclusion, subjects will be randomised and blinded to 16 weeks of progressive 30-45 min cycle ergometer interval training, applied 3 times a week while breathing either hyperoxic (100%O2, 4-8

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Type 2 diabetes according to WHO criteria for over 2 years VO2peak 60-90% of age-predicted value as measured on a cycle-ergometer Motivated and willing/able to travel 3 times a week to ErasmusMC and participate in a supervised exercise intervention program.

Exclusion criteria

Exclusion criteria: Use of Beta-blocker therapy, low molecular heparin, exogenous insulin therapy (for exercise intervention only), use of oral anti-coagulans therapy; decompensatio cordis, angina pectoris, myocardial infarction or positive signs of cardiac ischaemia on the ECG during the incremental exercise test;orthopaedic impairments that would limit participation in the training program; co-morbidity such as renal failure or > grade III retinopathy or previous diabetic foot ulcer; Cerebro-vascular disease (CVA), neurological diseases or deficits. 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
Relative improvements in vascular function parameters using forearm plethysmography (change in forearmbloodflow in ml/100g forearm/min na nitriprusside/acetylcholine), cardiovascular fitness (VO2max), systemic blood pressure, body composition, lipid metabolism and glycemic control.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)