Study of Sildenafil Citrate on Insulin Resistance in African American
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|ClinicalTrials.gov Identifier: NCT01334554|
Recruitment Status : Completed
First Posted : April 13, 2011
Results First Posted : April 10, 2015
Last Update Posted : March 27, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Metabolic Syndrome Obesity||Drug: Sildenafil Drug: Placebo||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||46 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Effect of Sildenafil Citrate on Insulin Resistance and Endothelial Function in Obese African American Women|
|Study Start Date :||April 2011|
|Actual Primary Completion Date :||August 2013|
|Actual Study Completion Date :||August 2013|
U.S. FDA Resources
Sildenafil 20 mg three times a day
20 mg three times a day.
Other Name: Revatio
Placebo Comparator: Placebo
No active drug
- Insulin Sensitivity [ Time Frame: Insulin sensitivity measured at baseline and 4 weeks after the intervention ]insulin sensitivity as measured by frequently sampled intravenous glucose tolerance test
- Endothelial Function [ Time Frame: Difference between FMD at baseline and 4 weeks ]Endothelial function was measured with flow mediated dilation, percent change
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01334554
|United States, Tennessee|
|Nashville, Tennessee, United States, 37232|
|Principal Investigator:||Cyndya Shibao, MD||Vanderbilt University|