Insulin resistance, endothelial dysfunction, cardiovascular fitness, cardio-respiratory responses, glycemic control in deconditioned non-insulin dependent type 2 diabetes patients
Conditions
Interventions
Trade Name: Compressed Air (35% oxygen in N2)
Product Name: Compressed Air
Product Code: not applicable
Pharmaceutical Form: Inhalation vapour
INN or Proposed INN: Oxygen
CAS Number: 7782-44-7
Current
Sponsors
Erasmus University Rotterdam
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Type 2 Diabetes Mellitus >3 months. • Age: 40-65 years. • BMI between 27 and 35 kg/m2. • Formal permission to participate in the study by signing an informed consent form. 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 12 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Cardiovascular disease: objective heart failure (ejection fraction <35%), electrocardiographically diagnosed cardiac ischemia or symptomatic peripheral vascular disease diagnosed by Doppler ultrasound investigation • Serious orthopedic of neurological conditions precluding an exercise test.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Measurement of the 24-hour glycemic profile in response to acute sub-maximal hypoxic and hyperoxic exercise in order to determine its effectiveness and select the most efficient method in reducing post-exercise hyperglycemia prevalence in comparison with normoxic conditions. ;Secondary Objective: Comparison and selection of oxygen conditions which amplify stimulation of muscle blood flow/ improve exercise tolerance during exertion. Moreover, obtained peripheral and central hemodynamic/respiratory responses will demonstrate the net result of acute exercise in various oxygen conditions. The latter will contribute to optimize exercise therapy in DM2 patients with impaired exercise tolerance and diabetes complications. ;Primary end point(s): Averages of glucose concentrations computed during the 24 h – continuous subcutaneous glycemia monitoring (CGMS) (GlucoDay®, A. Menarini) following exercise under various oxygen conditions. ;Timepoint(s) of evaluation of this end point: 01-03-2013 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Workload in watts and VO2max during maximal exercise test. • Performance on an sub-maximal exercise test (50% VO2max – relative workload to oxygen conditions). • Muscle blood flow (NIRS Portamon®) • Cardiac output (noninvasive thoracic bio-impedance method using Haemoseis 256®) • Intrapulmonary diffusing capacity (Master Screen PFT® (Viasys/Jaeger) • Sublingual microcirculation imaging (Sidestream Dark Field Imaging®) • Adrenaline and noradrenaline concentrations (plasma). • HbA1c (blood), plasma glucose. ;Timepoint(s) of evaluation of this end point: 01-03-2013 | — |
Countries
Netherlands
Contacts
Public ContactErasmus MC
Erasmus Medical Centre
Outcome results
None listed