Acute Effects of Sildenafil on Endothelial Function in People With Diabetes
Information source: Ruhr University of Bochum
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 2 Diabetes Mellitus; Endothelial Dysfunction
Intervention: Sildenafil (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Ruhr University of Bochum Official(s) and/or principal investigator(s):
Alin Stirban, MD, Principal Investigator, Affiliation: Heart and Diabetes Center NRW
Dan Ziegler, MD, Study Director, Affiliation: German Diabetes Center Duesseldorf
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.
Clinical Details
Official title: Acute Effects of Sildenafil on Flow Mediated Dilatation and Cardiovascular Autonomic Nerve Function in Type 2 Diabetic Patients
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Efficacy Study
Primary outcome: Improvement of flow mediated dilatation of the brachial artery following a single dose of 100mg Sildenafil.
Secondary outcome: 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.
Eligibility
Minimum age: 35 Years.
Maximum age: 70 Years.
Gender(s): Male.
Criteria:
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
Locations and Contacts
German Diabetes Center, Duesseldorf, North Rhine-Westphalia 40225, Germany
Additional Information
Starting date: August 2001
Ending date: June 2003
Last updated: September 10, 2007
|
