Acute Effects of Sildenafil on Endothelial Function in People With Diabetes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-08-31

Study Completion Date

2003-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Type 2 Diabetes Mellitus Endothelial Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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Sildenafil

Orally administered, Sildenafil 100mg, unique administration

Intervention Type DRUG

Other Intervention Names

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Viagra

Eligibility Criteria

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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

Minimum Eligible Age

35 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Principal Investigators

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Alin Stirban, MD

Role: PRINCIPAL_INVESTIGATOR

Heart and Diabetes Center NRW

Dan Ziegler, MD

Role: STUDY_DIRECTOR

German Diabetes Center Duesseldorf

Locations

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German Diabetes Center

Düsseldorf, North Rhine-Westphalia, Germany

Site Status

Countries

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Germany

Other Identifiers

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Sildenafil_ED_2001

Identifier Type: -

Identifier Source: org_study_id