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| ID | Type | Description | Link |
|---|---|---|---|
| 2R01HD035629-09A2 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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Increased insulin levels leads to increased secretion of D-chiro inositol(DCI) from the kidneys in women with PCOS, but not in normal women. This leads to a reduction in circulating DCI and insulin stimulated release of DCI-IPG.To determine if decreasing circulating insulin directly by inhibition of islet insulin release with diazoxide in obese women with PCOS 1)decreases the renal clearance of DCI and 2) increases the circulating concentration of DCI.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PCOS subjects | Experimental | PCOS subjects given diazoxide |
|
| Normal subjects | Active Comparator | Normal subjects given diazoxide |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| diazoxide | Drug | 100mg orally three times per day for 10 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Renal Clearance of D-chiroinositol (DCI) at 12 Days | Following inhibition of insulin release using diazoxide, measured renal clearance of D-chiro inositol (DCI) via urinary Chiro-inositol dci assay | 12 days |
| Level of Circulating D-chiro Inositol (DCI) | Measured circulating concentration of plasma DCI following inhibition of insulin release using diazoxide | 12 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John E. Nestler, MD | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General Clinical Research Center | Richmond | Virginia | 23298 | United States |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | PCOS Subjects | PCOS subjects given diazoxide diazoxide: 100mg orally three times per day for 10 days |
| FG001 | Normal Subjects | Normal subjects given diazoxide diazoxide: 100mg orally three times per day for 10 days |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Obese women with and without PCOS between the ages of 18-40 years selected after examination and eligibility screening
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| ID | Title | Description |
|---|---|---|
| BG000 | PCOS Subjects | PCOS subjects given diazoxide diazoxide: 100mg orally three times per day for 10 days |
| BG001 | Normal Subjects | Normal subjects given diazoxide diazoxide: 100mg orally three times per day for 10 days |
| 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 | Renal Clearance of D-chiroinositol (DCI) at 12 Days | Following inhibition of insulin release using diazoxide, measured renal clearance of D-chiro inositol (DCI) via urinary Chiro-inositol dci assay | Posted | Mean | Full Range | ml/min | 12 days |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PCOS Subjects | PCOS subjects given diazoxide diazoxide: 100mg orally three times per day for 10 days |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. John Nestler | Virginia Commonwealth University | 804-828-3389 | jnestler@mcvh-vcu.edu |
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| ID | Term |
|---|---|
| D003981 | Diazoxide |
| ID | Term |
|---|---|
| D001581 | Benzothiadiazines |
| D013449 | Sulfonamides |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
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| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI (Body Mass Index) | Mean | Full Range | kg/m^2 |
|
| Waist-to-hip ratio (WHR) | Mean | Full Range | unitless |
|
| Sex hormone binding globulin (SHBG) (nmol/L) | Mean | Full Range | nmol/L |
|
| Total testosterone (ng/mL) | Mean | Full Range | ng/mL |
|
| Free testosterone (pmol/L) | Mean | Full Range | pmol/L |
|
| Fasting glucose (mg/dl) | Mean | Full Range | mg/dl |
|
| Fasting insulin (ulU/mL) | Mean | Full Range | ulU/mL |
|
| Area under the curve (AUC) glucose (mg*min/dL) | Mean | Full Range | mg*min/dL |
|
| AUC insulin (mg*min/ml) | Mean | Full Range | mg*min/ml |
|
| Whole Body Insulin Sensitivity Index | Mean | Full Range | units on a scale |
|
| Plasma DCI (nmol/mL) | Mean | Full Range | nmol/mL |
|
| 24-h urinary D-chiroinositol (DCI) (nmol/day) | Mean | Full Range | nmol/day |
|
| Urinary clearance (uCl) DCI (ml/min) | Mean | Full Range | ml/min |
|
| Plasma myo-Inositol (MYO) (nmol/mL) | Mean | Full Range | nmol/mL |
|
| 24-h urinary MYO (nmol/day) | Mean | Full Range | nmol/day |
|
| uCI MYO (ml/min) | Mean | Full Range | ml/min |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Primary | Level of Circulating D-chiro Inositol (DCI) | Measured circulating concentration of plasma DCI following inhibition of insulin release using diazoxide | Posted | Mean | Full Range | nmol/mL | 12 days |
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | Normal Subjects | Normal subjects given diazoxide diazoxide: 100mg orally three times per day for 10 days | 0 | 9 | 0 | 9 |
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| D009930 |
| Organic Chemicals |
| D049971 | Thiazides |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |