Acute Effects of Sildenafil on Endothelial Function in People With Diabetes

This study has been completed.
Information provided by:
Ruhr University of Bochum Identifier:
First received: September 10, 2007
Last updated: NA
Last verified: September 2007
History: No changes posted
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 3

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

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:
    Drug: Sildenafil
    Orally administered, Sildenafil 100mg, unique administration
    Other Name: Viagra

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

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
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Please refer to this study by its identifier: NCT00527995

German Diabetes Center
Duesseldorf, North Rhine-Westphalia, Germany, 40225
Sponsors and Collaborators
Ruhr University of Bochum
Principal Investigator: Alin Stirban, MD Heart and Diabetes Center NRW
Study Director: Dan Ziegler, MD German Diabetes Center Duesseldorf
  More Information Identifier: NCT00527995     History of Changes
Other Study ID Numbers: Sildenafil_ED_2001 
Study First Received: September 10, 2007
Last Updated: September 10, 2007
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Cardiovascular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Therapeutic Uses
Urological Agents
Vasodilator Agents processed this record on April 27, 2016