insulin resistance, endothelial dysfunction, cardiovascular fitness, lipid metabolism and glycemic control in deconditioned non-insulin dependent type 2 diabetes patients MedDRA version: 9.1 Level: PT Classification code 10050322 Term: Oxygen supplementation
Conditions
Interventions
Trade Name: Medical Oxygen
Product Name: Medical Oxygen
Product Code: 097A
Pharmaceutical Form: Inhalation gas
CAS Number: 07782-44-7
Current Sponsor code: 2319569
Other descriptive name: O2
Concentra
Sponsors
Dutch Diabetes Research Foundation
Eligibility
Sex/Gender
All
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 willling/able to travel 3 times a week to ErasmusMC and participate in a supervised exercise intervention program. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: 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.;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 | — |
Countries
Netherlands
Outcome results
None listed