Acute Effects of Sildenafil on Endothelial Function in People With Diabetes

• Status: Completed
• Trial end date: 2003-06-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ruhr University of Bochum
• Treatments: Sildenafil Citrate

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