NCT00527995

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at below P25 for phase_3 type-2-diabetes-mellitus

Timeline
Completed

Started Aug 2001

Typical duration for phase_3 type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2001

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2003

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

September 10, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 11, 2007

Completed
Last Updated

September 11, 2007

Status Verified

September 1, 2007

First QC Date

September 10, 2007

Last Update Submit

September 10, 2007

Conditions

Type 2 Diabetes MellitusEndothelial Dysfunction

Outcome Measures

Primary Outcomes (1)

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

    60 minutes

Secondary Outcomes (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.

    60 minutes

Interventions

SildenafilDRUG

Orally administered, Sildenafil 100mg, unique administration

Also known as: Viagra

Eligibility Criteria

Age35 Years - 70 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 35-70
  • type 2 diabetes mellitus
  • impotence
  • with and without hypertension, hypercholesteremia

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

German Diabetes Center

Düsseldorf, North Rhine-Westphalia, 40225, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsSulfonesSulfur CompoundsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Alin Stirban, MD

    Heart and Diabetes Center NRW

    PRINCIPAL INVESTIGATOR

  • Dan Ziegler, MD

    German Diabetes Center Duesseldorf

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 10, 2007

First Posted

September 11, 2007

Study Start

August 1, 2001

Study Completion

June 1, 2003

Last Updated

September 11, 2007

Record last verified: 2007-09

Locations

DE(1)