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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 is a Phase 1 study that has completed, run by Vanderbilt University Medical Center. The registered enrollment target is 46 participants.
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.
Interventions
- DRUG Placebo
- DRUG Sildenafil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2011-04 |
| Est. Completion | 2013-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01334554
The ClinicalTrials.gov registry entry for NCT01334554 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 46 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vanderbilt University Medical Center, which has 677 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01334554 reports 0 study locations.
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.
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