Text Size

Acute Effects of Sildenafil on Endothelial Function in People With Diabetes

This study has been completed.
Sponsor:
Information provided by:
Ruhr University of Bochum
ClinicalTrials.gov Identifier:
NCT00527995
First received: September 10, 2007
Last updated: NA
Last verified: September 2007
History: No changes posted
  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 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:

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

ClinicalTrials.gov 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
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sildenafil
Vasodilator Agents
 Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 21, 2013