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Acute Effects of Sildenafil on Endothelial Function in People With Diabetes

Primary Purpose

Type 2 Diabetes Mellitus, Endothelial Dysfunction

Status

Completed

Phase

Phase 3

Locations

Germany

Study Type

Interventional

Intervention

Sildenafil

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

35 Years - 70 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

German Diabetes Center

Outcomes

Primary Outcome Measures

Improvement of flow mediated dilatation of the brachial artery following a single dose of 100mg Sildenafil.

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.

Full Information

NCT ID

NCT00527995

First Posted

September 10, 2007

Last Updated

September 10, 2007

Sponsor

Ruhr University of Bochum

1. Study Identification

Unique Protocol Identification Number

NCT00527995

Brief Title

Acute Effects of Sildenafil on Endothelial Function in People With Diabetes

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2007

Overall Recruitment Status

Completed

Study Start Date

August 2001 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

June 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Ruhr University of Bochum

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes Mellitus, Endothelial Dysfunction

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Sildenafil

Other Intervention Name(s)

Viagra

Intervention Description

Orally administered, Sildenafil 100mg, unique administration

Primary Outcome Measure Information:

Title

Improvement of flow mediated dilatation of the brachial artery following a single dose of 100mg Sildenafil.

Time Frame

60 minutes

Secondary Outcome Measure Information:

Title

Time Frame

60 minutes

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

35 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alin Stirban, MD

Organizational Affiliation

Heart and Diabetes Center NRW

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Dan Ziegler, MD

Organizational Affiliation

German Diabetes Center Duesseldorf

Official's Role

Study Director

Facility Information:

Facility Name

German Diabetes Center

City

Duesseldorf

State/Province

North Rhine-Westphalia

ZIP/Postal Code

40225

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

Acute Effects of Sildenafil on Endothelial Function in People With Diabetes

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