Acute Effects of Sildenafil on Endothelial Function in People With Diabetes
Phase 3
Completed
- Conditions
- Type 2 Diabetes MellitusEndothelial Dysfunction
- Registration Number
- NCT00527995
- Lead Sponsor
- Ruhr University of Bochum
- Brief Summary
This is a double-blind, placebo-controlled, cross-over trial using a single dose of 100 mg sildenafil or placebo in 40 subjects with T2DM without known cardiovascular disease. Effects on haemodynamic parameters, flow mediated dilatation (FMD) in brachial artery, cardiovascular autonomic function tests, and spontaneous baroreflex sensitivity (BRS) were investigated.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 40
Inclusion Criteria
- age 35-70
- type 2 diabetes mellitus
- impotence
- with and without hypertension, hypercholesteremia
Exclusion Criteria
- patients with history of cardiovascular and malignant disease,
- advanced nephropathy (creatinine≥2.2mg/dl)
- hepatopathy (liver enzymes higher than the double of normal values)
- patients taking nitrates
- CHF: NYHA > II
- Stable angina: CCS > II
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Improvement of flow mediated dilatation of the brachial artery following a single dose of 100mg Sildenafil. 60 minutes
- Secondary Outcome Measures
Name Time Method Change in hemodynamics and cardiovascular parasympathetic and sympathetic nerve function using time domain and frequency domain indexes of heart rate variability (HRV) and baroreflex sensitivity (BRS) following a single dose of 100mg Sildenafil. 60 minutes
Trial Locations
- Locations (1)
German Diabetes Center
🇩🇪Duesseldorf, North Rhine-Westphalia, Germany