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Supplemental oxygen to improve the efficiency of exercise training therapy in type 2 diabetes patients.


- candidate number6485
- NTR NumberNTR2014
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR16-sep-2009
- Secondary IDs2009-125 METC Erasmus MC
- Public TitleSupplemental oxygen to improve the efficiency of exercise training therapy in type 2 diabetes patients.
- Scientific TitleHyperoxic exercise training as an innovative therapy to improve metabolic control, endothelial dysfunction and physical fitness in deconditioned type 2 diabetes patients.
- ACRONYMHOEX (Hyperoxic Exercise)
- hypothesisThis research project hypothesises that hyperoxic interval training improves whole body insulin resistance, endothelial dysfunction, cardiovascular fitness, lipid metabolism and glycemic control in the treatment of deconditioned non-insulin dependent type 2 diabetes patients.
- Healt Condition(s) or Problem(s) studiedDiabetes Mellitus Type 2 (DM type II)
- Inclusion criteria1. 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 criteria1. 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).
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 17-sep-2009
- planned closingdate1-jun-2011
- Target number of participants36
- InterventionsAfter 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 interval training, applied 3 times a week while breathing either hyperoxic (100%O2, 4-8 L/min) or normoxic (21%O2-79%N2, 4-8L/min) humidified air (=placebo) through a nasal tube (substudy 2).
- Primary outcomeMain study parameters/endpoints: The main study parameter and end-point is the relative improvement in whole-body insulin sensitivity.
- Secondary outcomeSecondary end-points are relative improvements in vascular function parameters using forearm plethysmography, cardiovascular fitness, systemic blood pressure, body composition, lipid metabolism and glycemic control.
- Timepoints1. Baseline measurements aftrer inclusion;
2. Endpoint measurements after 16 weeks.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. S.F.E. Praet
- CONTACT for SCIENTIFIC QUERIESDr. S.F.E. Praet
- Sponsor/Initiator Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Diabetes Fund, Amersfoort, the Netherlands
- PublicationsN/A
- Brief summaryRationale:
Type 2 diabetes patients frequently suffer from physical deconditioning and vascular disease. Although the exact mechanisms are unclear, microvascular changes and endothelial dysfunction appear to inhibit the oxygen transport and uptake in peripheral skeletal muscle of type 2 diabetes patients. Hyperoxic-training has been shown a safe intervention to increase exercise capacity and energy expenditure and is now routinely used for athletes (‘live-high, train-low’) and COPD patients. Furthermore, in COPD patients normalisation of oxygen saturation improves insulin sensivity.

Objective:
This research project aims to investigate (1) whether hyperoxic interval training improves insulin resistance, endothelial dysfunction, cardiovascular fitness, lipid metabolism and glycemic control in the treatment of deconditioned non-insulin dependent type 2 diabetes patients and (2) the pathophysiological role of endothelial dysfunction and insulin. resistance on the adaptive response to exercise.

Study design:
double-blind placebo controlled intervention study. Study population:
36 deconditioned non-insulin dependent type 2 diabetes patients.

Intervention:
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 L/min) or normoxic (21%O2-79%N2, 4-8L/min) humidified air (=placebo) through a nasal tube.

Main study parameters/endpoints:
The main study parameter and end-point is the relative improvement in whole-body insulin sensitivity. 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.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
Before inclusion subjects will undergo a physical examination and X-ECG to exclude cardiovascular disease and assess cardiorespiratory status. A subgroup of 12 subjects will undergo a submaximal exercise test while obtaining arteriovenous blood samples to optimize oxygen flow during exercise. All 36 participating subjects will be asked to attend a total of 48 supervised exercise sessions of 45 min. To minimize the risk for a hypoglycemic event during the first 2 weeks of the exercise intervention, capillary blood glucose will be measured following exercise. If necessary medication will be adjusted. Independent of oxygen concentration in the air mixture, patients are expected to improve their physical fitness and metabolic control. Beside the direct therapeutic effects, both interventions are expected to improve general health and well-being. Although unlikely, in theory hyperoxic exercise training might worsen diabetes related retinopathy. Therefore, an experienced ophthalmologist will monitor and stage diabetic retinopathy before and after the 16 weeks training program. Dual energy x-ray absorptiometry will be used to assess changes in body composition. Frequently sampled intravenous and forearm venous occlusion plethysmography following intrabrachial infusions of methacholine and sodium nitroprusside will be applied. Participating subjects will visit the clinical research unit 9 times over a 5 months time period, equivalent to a 22 hours time load. Over a period of 20 weeks multiple arterialised and venous blood samples (equivalent to 258 cc) will be drawn through an intravenous/arterial catheter.
- Main changes (audit trail)
- RECORD16-sep-2009 - 29-okt-2009


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