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

• Conditions: insulin resistance, endothelial dysfunction, cardiovascular fitness, lipid metabolism and glycemic control in deconditioned non-insulin dependent type 2 diabetes patients; MedDRA version: 9.1Level: PTClassification code 10050322Term: Oxygen supplementation

• Registration Number: EUCTR2009-011448-20-NL
• Lead Sponsor: Dutch Diabetes Research Foundation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05-25
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified