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

Recruiting

Conditions: adult onset diabetes
Diabetes type 2
10018424

Registration Number: NL-OMON33119

Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 48

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The relative improvement in whole-body insulin sensitivity. An insulin<br /><br>sensitivity index (SI) will be calculated by using the minimal model (Bergman<br /><br>et al 1985); a higher SI indicates enhanced insulin sensitivity. Acute-phase<br /><br>insulin secretion<br /><br>(AIRG) and glucose effectiveness (SG) were also determined from the IVGTT (<br /><br>Bergman et al 1985).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Relative improvements in vascular function parameters using forearm<br /><br>plethysmography (change in forearmbloodflow in ml/100g forearm/min na<br /><br>nitriprusside/acetylcholine), cardiovascular fitness (VO2max), systemic blood<br /><br>pressure, body composition, lipid metabolism and glycemic control.</p><br>