Acute Effects of Sildenafil on Endothelial Function in People With Diabetes

Type 2 Diabetes Mellitus Clinical Trial

Official title:

Acute Effects of Sildenafil on Flow Mediated Dilatation and Cardiovascular Autonomic Nerve Function in Type 2 Diabetic Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00527995
• Other study ID #: Sildenafil_ED_2001
• Status: Completed
• Phase: Phase 3
• First received: September 10, 2007
• Last updated: September 10, 2007
• Start date: August 2001
• Est. completion date: June 2003

Study information

• Verified date: September 2007
• Source: Ruhr University of Bochum
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2003
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 35 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Endothelial Dysfunction
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Sildenafil
Orally administered, Sildenafil 100mg, unique administration

Locations

Country	Name	City	State
Germany	German Diabetes Center	Duesseldorf	North Rhine-Westphalia

Sponsors (1)

Lead Sponsor	Collaborator
Ruhr University of Bochum

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of flow mediated dilatation of the brachial artery following a single dose of 100mg Sildenafil.		60 minutes
Secondary	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