Acute Effects of Sildenafil on Endothelial Function in People With Diabetes - Full Text View

Sponsor:	Ruhr University of Bochum
Information provided by:	Ruhr University of Bochum
ClinicalTrials.gov Identifier:	NCT00527995

Purpose

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.

Condition	Intervention	Phase
Type 2 Diabetes Mellitus Endothelial Dysfunction	Drug: Sildenafil	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Efficacy Study
Official Title:	Acute Effects of Sildenafil on Flow Mediated Dilatation and Cardiovascular Autonomic Nerve Function in Type 2 Diabetic Patients

Resource links provided by NLM:

MedlinePlus related topics: Diabetes

Drug Information available for: Sildenafil Sildenafil citrate

U.S. FDA Resources

Further study details as provided by Ruhr University of Bochum:

Primary Outcome Measures:

Improvement of flow mediated dilatation of the brachial artery following a single dose of 100mg Sildenafil. [ Time Frame: 60 minutes ]

Secondary Outcome Measures:

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. [ Time Frame: 60 minutes ]

Enrollment:	40
Study Start Date:	August 2001
Study Completion Date:	June 2003

Intervention Details:

Orally administered, Sildenafil 100mg, unique administration

Eligibility

Ages Eligible for Study:	35 Years to 70 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00527995

Locations

Germany, North Rhine-Westphalia
German Diabetes Center
Duesseldorf, North Rhine-Westphalia, Germany, 40225

Sponsors and Collaborators

Ruhr University of Bochum

Investigators

Principal Investigator:	Alin Stirban, MD	Heart and Diabetes Center NRW
Study Director:	Dan Ziegler, MD	German Diabetes Center Duesseldorf

More Information

No publications provided

Study ID Numbers:	Sildenafil_ED_2001
Study First Received:	September 10, 2007
Last Updated:	September 10, 2007
ClinicalTrials.gov Identifier:	NCT00527995 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:

Vasodilator Agents
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Diabetes Mellitus
Endocrine System Diseases
Sildenafil
Enzyme Inhibitors

Cardiovascular Agents
Pharmacologic Actions
Phosphodiesterase Inhibitors
Therapeutic Uses
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on November 27, 2009