Diabetes and vascular complications: the role of endothelin and physical inactivity’

• Conditions: type 2 diabetes mellius; MedDRA version: 12.0Level: LLTClassification code 10012613Term: Diabetes mellitus non-insulin-dependent

• Registration Number: EUCTR2009-015602-18-NL
• Lead Sponsor: Actelion Pharmaceuticals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08-21
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

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

Inclusion Criteria

-Older than 40 years (for both groups)
-Diagnosed with type 2 diabetes mellitus at least 2 years ago (for the group of type 2 diabetes patients only)

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) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Subjects that use glibenclamide (glyburide), an oral anti-diabetic drug
-Liver problems (mild, moderate and/or severe liver impairment
-Increased levels of liver aminotransferase (> 3 times the upper limit of normal)
-Pregnant or lactating women, women on contraceptive
-Cardiovascular disease
-Hypercholesterolemia
-Hypertension (>160 mmHg systolic and/or >90 mmHg diastolic pressure)
-Smoking
-Type I diabetes mellitus
-Older than 65 years
-Subjects with vascular complications due to type 2 diabetes mellitus (e.g. diabetic foot ulcer)

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: Our first aim is to examine the effect of 8-week exercise training on the contribution of ET to regulate leg vascular tone in type 2 diabetes. ;Secondary Objective: Secondly, we will examine the contribution of ET to the impaired blood flow to leg exercise in type 2 diabetes before and after the 8-week exercise training. Third, we will also examine the effect of exercise training combined with ET-receptor blockade on the contribution of ET to baseline and exercise-induced leg blood flow;Primary end point(s): 1)Contribution of ET to leg baseline blood flow<br>2)Contribution of ET to exercise-induced blood flow<br>3)Endothelial function (measured as the flow-mediated dilation (FMD))<br>