Endothelial Dysfunction, Type 2 Diabetes Mellitus
Conditions
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.
Interventions
DRUGSildenafil
Orally administered, Sildenafil 100mg, unique administration
Sponsors
Ruhr University of Bochum
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
35 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement of flow mediated dilatation of the brachial artery following a single dose of 100mg Sildenafil. | 60 minutes |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Germany
Outcome results
None listed