Acute Effects of Sildenafil on Endothelial Function in People With Diabetes

Ruhr University of Bochum40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Type 2 Diabetes Mellitus Endothelial Dysfunction

Interventions

SildenafilDRUG

Orally administered, Sildenafil 100mg, unique administration

Eligibility

Sex: MALEMin age: 35 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

German Diabetes Center

Düsseldorf, North Rhine-Westphalia, Germany

Outcomes

Primary Outcomes

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

Time frame: 60 minutes

Secondary Outcomes

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

Data from ClinicalTrials.gov

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