Acute Effects of Sildenafil on Endothelial Function in People With Diabetes

Ruhr University of Bochum

Status and phase: Completed; Phase 3

Conditions: Endothelial Dysfunction; Type 2 Diabetes Mellitus

Treatments: Drug: Sildenafil

Study type: Interventional

Funder types: Other

Identifiers

NCT00527995

Sildenafil_ED_2001

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: Male

Ages: 35 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind