The effect of selective PDE-5 inhibition on capillary recruitment, glucose uptake and endothelial function following a mixed meal in patients with type 2 diabetes
- Conditions
- Our primary objective is to elucidate whether increase in cGMP mediated by acute administration of tadalafil, a selective well tolerated PDE-5 inhibitor, may affect capillary recruitment and muscle glucose uptake in type 2 diabetes subjects following a mixed meal. Our secondary objective is to elucidate whether tadalafil may modulate arterial stiffness as indicated by changes in pulse wave velocity.MedDRA version: 9.1Level: LLTClassification code 10012613Term: Diabetes mellitus non-insulin-dependent
- Registration Number
- EUCTR2007-003921-25-SE
- Lead Sponsor
- Västra Götalandsregionen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
To be acceptable for the study the type 2 diabetic subjects have to fulfill the following criteria: 1) Post-menopausal state, defined as natural amenorrhea for at least 12 months, age 52-67 yr or males 40-65 years; 2) Type 2 diabetes diagnosed or indicated by fasting or 2-hr OGTT plasma glucose levels (diabetes duration < 3 years).
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
1) Subjects with concurrent use of nitrates or NO donors, history of coronary heart or cerebrovascular disease, cardiac failure (stages NYHA II-IV), uncontrolled hypertension, significant diabetic complications, and inadequate glycemic control (HbA1c > 6.5%, ref values: 3.5-5.3%) will be excluded; 2) Patients on glitazones, insulin, beta-blockers, ACE-inhibitors, Angiotensin II Receptor subtype 1 Blocker or corticosteroids will be excluded.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To elucidate whether increase in cGMP mediated by acute administration of tadalafil, a selective well tolerated PDE-5 inhibitor, may affect capillary recruitment and muscle glucose uptake in type 2 diabetes subjects following a mixed meal. <br><br>;Secondary Objective: To elucidate whether tadalafil may modulate arterial stiffness as indicated by changes in pulse wave velocity. <br><br>;Primary end point(s): The primary endpoints are PS for glucose in muscle and uptake of glucose in the brachioradialis muscle following a mixed meal as well as Area Under the Curve (AUC) for plasma glucose following the meal. If the data suggest an enhanced glucose uptake induced by tadalafil there may be a new indication for the drug. The secondary endpoint will be to estimate the effects of tadalafil on indices of arterial stiffness. <br><br>
- Secondary Outcome Measures
Name Time Method