Trial · NCT01334554

Study of Sildenafil Citrate on Insulin Resistance in African American

NCT01334554, Phase 1, Phase 2, Completed, Vanderbilt University Medical Center; results first posted 2015-04-10

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study of Sildenafil Citrate on Insulin Resistance in African American. Trials, record NCT01334554. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01334554

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study of Sildenafil Citrate on Insulin Resistance in African American
NCT number: NCT01334554
Status: Completed
Phases: Phase 1, Phase 2
Enrollment: 46 participants, actual
Lead sponsor: Vanderbilt University Medical Center
Conditions: Metabolic Syndrome, Obesity
Interventions: Sildenafil, Placebo
First posted: 2011-04-13
Last updated: 2017-03-27
Results first posted: 2015-04-10

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Insulin Sensitivity	Insulin sensitivity measured at baseline and 4 weeks after the intervention	insulin sensitivity as measured by frequently sampled intravenous glucose tolerance test
Secondary	Endothelial Function	Difference between FMD at baseline and 4 weeks	Endothelial function was measured with flow mediated dilation, percent change

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Insulin Sensitivity	Insulin sensitivity measured at baseline and 4 weeks after the intervention		min-1/pmol/mlx10-5	MEDIAN
SECONDARY	Endothelial Function	Difference between FMD at baseline and 4 weeks	We detected problems with the ultrasound images obtained to measure flow mediated dilation and therefore only data in 14 subjects in the sildenafil group and in 16 subjects in the placebo were analyzed.	percentage of brachial artery diameter	MEAN

Source ClinicalTrials.gov

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Insulin Sensitivity	Sildenafil	Baseline	3.4	Standard Deviation 2.53	min-1/pmol/mlx10-5
Insulin Sensitivity	Placebo	Baseline	2.7	Standard Deviation 1.83	min-1/pmol/mlx10-5
Insulin Sensitivity	Sildenafil	4-week during intervention	3.2	Standard Deviation 3.02	min-1/pmol/mlx10-5
Insulin Sensitivity	Placebo	4-week during intervention	3.0	Standard Deviation 2.12	min-1/pmol/mlx10-5
Endothelial Function	Sildenafil		4.7	Standard Deviation 2.9	percentage of brachial artery diameter
Endothelial Function	Placebo		5.3	Standard Deviation 3.1	percentage of brachial artery diameter

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Sildenafil	23
Overall Study	STARTED	Placebo	23
Overall Study	COMPLETED	Sildenafil	19
Overall Study	COMPLETED	Placebo	21
Overall Study	NOT COMPLETED	Sildenafil	4
Overall Study	NOT COMPLETED	Placebo	2

Source ClinicalTrials.gov

Adverse events14

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Headaches	Nervous system disorders	Sildenafil	12	23	20
other	Headaches	Nervous system disorders	Placebo	7	23	10
other	dizziness	Nervous system disorders	Sildenafil	5	23	6
other	dizziness	Nervous system disorders	Placebo	1	23	1
other	back ache	Musculoskeletal and connective tissue disorders	Sildenafil	3	23	3
other	back ache	Musculoskeletal and connective tissue disorders	Placebo	2	23	3
other	lightheadedness	Nervous system disorders	Sildenafil	3	23	3
other	lightheadedness	Nervous system disorders	Placebo	0	23	0
other	edema	Musculoskeletal and connective tissue disorders	Sildenafil	2	23	5
other	edema	Musculoskeletal and connective tissue disorders	Placebo	0	23	0

1 to 10 of 14Source ClinicalTrials.gov

See all 14 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Sildenafil
Total, all-cause mortality	Placebo
Total, other adverse events	Sildenafil	17	23
Total, other adverse events	Placebo	14	23
Total, serious adverse events	Sildenafil	0	23
Total, serious adverse events	Placebo	0	23

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
26541392	DERIVED

Source PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
K23HL103976	Obesity hypertension in African American women: Neuro-metabolic mechanisms	SHIBAO, CYNDYA ADRIANA	VANDERBILT UNIVERSITY MEDICAL CENTER	NATIONAL HEART, LUNG, AND BLOOD INSTITUTE	2010 to 2014

Source NIH RePORTER

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Sildenafil vs Placebo: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01334554

GET https://conductscience.org/api/trials/v1/NCT01334554/registered

API reference For AI assistants