type 2 diabetes mellius MedDRA version: 12.0 Level: LLT Classification code 10012613 Term: Diabetes mellitus non-insulin-dependent
Conditions
Interventions
Trade Name: Tracleer
Product Name: Tracleer
Product Code: Tracleer-H-C-401-II-40
Pharmaceutical Form: Film-coated tablet
CAS Number: 157212-55-0
Other descriptive name: BOSENTAN MONOHYDRATE
Concentrat
Sponsors
Actelion Pharmaceuticals
Eligibility
Sex/Gender
All
Inclusion criteria
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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 2) Contribution of ET to exercise-induced blood flow 3) Endothelial function (measured as the flow-mediated dilation (FMD)) | — |
Countries
Netherlands
Outcome results
None listed