E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
insulin resistance, endothelial dysfunction, cardiovascular fitness, lipid metabolism and glycemic control in deconditioned non-insulin dependent type 2 diabetes patients |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10050322 |
E.1.2 | Term | Oxygen supplementation |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
This research project aims to investigate whether 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. |
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E.2.2 | Secondary objectives of the trial |
To improve our understanding on the pathophysiological role of endothelial dysfunction and insulin resistance on the adaptive response to exercise. To assess the safety of hyperoxic exercise in type 2 diabetes. |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
TITLE: Dose-response relation of hyperoxic exercise training in deconditioned type 2 diabetes patients.
DATE: 5-2-2009
VERSION: 1.0
OBJECTIVE: Obtaining the dose of oxygen supplementation producing the maximal enhancement external power output at 65% of the maximum heart rate. |
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E.3 | Principal 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 willling/able to travel 3 times a week to ErasmusMC and participate in a supervised exercise intervention program.
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E.4 | Principal exclusion criteria |
Use of ß-blocker therapy, exogenous insulin therapy, 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) |
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E.5 End points |
E.5.1 | Primary end point(s) |
Main study parameter/endpoint 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 study parameters/endpoints Relative improvements in vascular function parameters using forearm plethysmography (change in forearmbloodflow in ml/100g forearm/min na nitriprusside/metacholine), cardiovascular fitness (VO2max), systemic blood pressure, body composition, lipid metabolism and glycemic control.
Other study parameters Baseline fitness (VO2peak, Wmax during RAMP and SteepRAMP), baseline glycemic control (HbA1c), number of exercise sessions, absolute exercise intensity (average heart rate during exercise sessions as percentage of maximum heart rate), oxidative stress (total endogenous anti-oxidant concentration (TEAC), glutathione reductase and glutathione reductase disulphide (GSSG) in plasma. Level of diabetic retinopathy
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 18 |
E.8.9.1 | In the Member State concerned days | |