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NCT01334554 · ClinicalTrials.gov registry record · Phase 1
Study of Sildenafil Citrate on Insulin Resistance in African American
A Phase 1 study, sponsored by Vanderbilt University Medical Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 46
- Enrollment target
NCT01334554: Completed Phase 1 study, sponsored by Vanderbilt University Medical Center.
NCT01334554 is a Phase 1 study that has completed, run by Vanderbilt University Medical Center. The registered enrollment target is 46 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (23% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01334554, a Phase 1 study, has completed, sponsored by Vanderbilt University Medical Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 46 participants
- Enrollment target
Study 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.
Primary Outcome
insulin sensitivity as measured by frequently sampled intravenous glucose tolerance test
Interventions
- DRUG Placebo
- DRUG Sildenafil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2011-04 |
| Est. Completion | 2013-08 |
| Phase | Phase 1 |
What the finished NCT01334554 record still lists
NCT01334554 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (23% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01334554 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01334554 about?
NCT01334554 is a clinical study titled "Study of Sildenafil Citrate on Insulin Resistance in African American". 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 compare...
What is the current status of trial NCT01334554?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 46 participants. The study started on 2011-04. Estimated completion is 2013-08.
What interventions are being tested in trial NCT01334554?
The interventions under investigation include: Placebo (DRUG), Sildenafil (DRUG).
Who is sponsoring clinical trial NCT01334554?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01334554's enrollment target sits among peer trials
46 1058th of 2000 higher than 935 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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