CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 46 enrolled
Drug / intervention
Sildenafil +1 moredrug
Likely dose
Sildenafil 20 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01334554
NCT01334554Phase 2Completed

Effect of Sildenafil Citrate on Insulin Resistance and Endothelial Function in Obese African American Women

Vanderbilt University Medical Center·interventional·Posted Apr 13, 2011·Updated Mar 27, 2017

In Brief

A Phase 2 clinical trial evaluating Sildenafil and Placebo for Metabolic Syndrome and Obesity. Completed, enrolled 46 participants across 1 site.

Detailed Summary

Obesity has a greater detrimental impact on the health of African American women than on any other racial or gender group. Nearly 80% of African American women are overweight or obese in the United States. Hypertension and insulin resistance are more prevalent among African American women as compared to men and Caucasians. These conditions put them at increased risk for the development of diabetes mellitus and cardiovascular disease. Recent studies have reported that a substance named Nitric Oxide (NO)may have some beneficial effect on how the body handles blood sugar and blood pressure. Of interest,some studies have shown that African Americans have decreased function of NO in their blood vessels. In this study proposal the investigators will test if increasing NO function with a PDE-5 inhibitor (sildenafil citrate) will improve pre-diabetes and the health of the inner layer of the blood vessels in obese African American women.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedApr 13, 2011
Enrollment StartApr 1, 2011
Primary CompletionAug 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 15.2 years ago

Interventions

Sildenafildrug

20 mg three times a day.

Placebodrug

No active drug