Acute Effects of Sildenafil on Endothelial Function in People With Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00527995
Recruitment Status : Completed
First Posted : September 11, 2007
Last Update Posted : September 11, 2007
Information provided by:
Ruhr University of Bochum

Brief 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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Endothelial Dysfunction Drug: Sildenafil Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Acute Effects of Sildenafil on Flow Mediated Dilatation and Cardiovascular Autonomic Nerve Function in Type 2 Diabetic Patients
Study Start Date : August 2001
Actual Study Completion Date : June 2003

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

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

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   35 Years to 70 Years   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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 Identifier: NCT00527995     History of Changes
Other Study ID Numbers: Sildenafil_ED_2001
First Posted: September 11, 2007    Key Record Dates
Last Update Posted: September 11, 2007
Last Verified: September 2007

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sildenafil Citrate
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents