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 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.
|Metabolic Syndrome Obesity||Drug: Sildenafil Drug: Placebo||Phase 1 Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
|Official Title:||Effect of Sildenafil Citrate on Insulin Resistance and Endothelial Function in Obese African American Women|
- 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
|Study Start Date:||April 2011|
|Study Completion Date:||August 2013|
|Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
Sildenafil 20 mg three times a day
20 mg three times a day.
Other Name: Revatio
Placebo Comparator: Placebo
No active drug
Please refer to this study by its ClinicalTrials.gov identifier: NCT01334554
|United States, Tennessee|
|Nashville, Tennessee, United States, 37232|
|Principal Investigator:||Cyndya Shibao, MD||Vanderbilt University|