Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| K23HL103976 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| Pfizer | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sildenafil | Experimental | Sildenafil 20 mg three times a day |
|
| Placebo | Placebo Comparator | placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sildenafil | Drug | 20 mg three times a day. |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Insulin Sensitivity | insulin sensitivity as measured by frequently sampled intravenous glucose tolerance test | Insulin sensitivity measured at baseline and 4 weeks after the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Endothelial Function | Endothelial function was measured with flow mediated dilation, percent change | Difference between FMD at baseline and 4 weeks |
Not provided
Inclusion Criteria:
Fasting blood glucose of greater than 100 Triglyceride levels of greater than 150 HDL cholesterol of less than 50 in women Blood pressure of at least 130/85, or on blood pressure medicine Waist girth of more than 35 inches in women. Subjects of childbearing potential will be required to have a negative serum/urine pregnancy test. In addition, they will be asked to use a reliable contraceptive method prior to enrollment as determined by the PI (Dr. Cyndya Shibao).
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Cyndya Shibao, MD | Vanderbilt University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University | Nashville | Tennessee | 37232 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26541392 | Derived | Marinos A, Celedonio JE, Ramirez CE, Gottlieb J, Gamboa A, Hui N, Yu C, Stein CM, Biaggioni I, Shibao CA. Time-Course Analysis of Flow Mediated Dilation for the Evaluation of Endothelial Function After a High-Fat Meal in African Americans. J Am Heart Assoc. 2015 Nov 5;4(11):e002388. doi: 10.1161/JAHA.115.002388. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
We screened 132 participants. Eighty six participants were excluded because of the following reasons:
The recruitment started on 03/16/2011 and the first subject was screened on 03/17/2011. Participants were enrolled at Vanderbilt University Medical Center.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Sildenafil | Participants received sildenafil citrate 20 mg three times a day in a fasting condition for 4 weeks |
| FG001 | Placebo | Participants received placebo three times a day for 4 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Sildenafil | Sildenafil 20 mg three times a day for 4 weeks |
| BG001 | Placebo | Placebo three times a day for 4 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Insulin Sensitivity | insulin sensitivity as measured by frequently sampled intravenous glucose tolerance test | Posted | Median | Standard Deviation | min-1/pmol/mlx10-5 | Insulin sensitivity measured at baseline and 4 weeks after the intervention |
|
|
4 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sildenafil | Participants received sildenafil citrate 20 mg three times a day in a fasting condition for 4 weeks |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headaches | Nervous system disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cyndya A. Shibao | Vanderbilt University Medical Center | 6159364584 | cyndya.shibao@vanderbilt.edu |
Not provided
| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068677 | Sildenafil Citrate |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | No active drug |
|
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Height | Mean | Standard Deviation | cm |
|
| Weight | Mean | Standard Deviation | kG |
|
| Body mass index | Mean | Standard Deviation | kg/m^2 |
|
| Waist circumference | Mean | Standard Deviation | cm |
|
| HDL | Mean | Standard Deviation | mg/dL |
|
| triglycerides | Mean | Standard Deviation | mg/dL |
|
| glucose | Mean | Standard Deviation | mg/dL |
|
| insulin | Mean | Standard Deviation | uU/ml |
|
| Participants |
|
|
|
| Secondary | Endothelial Function | Endothelial function was measured with flow mediated dilation, percent change | 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. | Posted | Mean | Standard Deviation | percentage of brachial artery diameter | Difference between FMD at baseline and 4 weeks | percent change of brachial artery diamet | percent change of brachial artery diamet |
|
|
|
|
| 0 |
| 23 |
| 17 |
| 23 |
| EG001 | Placebo | Participants received placebo three times a day for 4 weeks | 0 | 23 | 14 | 23 |
| dizziness | Nervous system disorders | Systematic Assessment |
|
| back ache | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| lightheadedness | Nervous system disorders | Systematic Assessment |
|
| edema | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| sinus infection | Ear and labyrinth disorders | Systematic Assessment |
|
| flushing | General disorders | Systematic Assessment |
|
Not provided
| D009750 |
| Nutritional and Metabolic Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Sulfur Compounds |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |