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In girls with elevated androgens the precise source of androgen excess throughout puberty and early adolescence has not been carefully examined. The investigators propose to examine whether the adrenal gland produces the majority of androgens during puberty by studying the differences in androgen responses to adrenocorticotropin hormone (ACTH) administration in normal weight (NW) and obese (OB) girls ages 7-18. The investigators' analyses will compare steroid changes before and 60 min after ACTH administration in NW and OB girls.
Subjects will have blood drawn at 1900 hr for baseline hormone measurements. At 2200 hr each subject will take a single oral dose of dexamethasone at 2200 hr. At 0700 hr the following day, subjects will have a blood sample drawn for hormone measurements. After this blood sample, 0.25 mg adrenocorticotropin hormone (ACTH) will be administered as an iv bolus. At 30 and 60 minutes after Cosyntropin, blood samples will be obtained for repeat hormone measurements.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Obese group | Experimental | Subjects will have blood drawn at 1900 hr for baseline hormone measurements. At 2200 hr each subject will take a single oral dose of dexamethasone at 2200 hr. At 0700 hr the following day, subjects will have a blood sample drawn for hormone measurements. After this blood sample, adrenocorticotropin (ACTH) will be administered as an iv bolus. At 30 and 60 minutes after ACTH, blood samples will be obtained for repeat hormone measurements. |
|
| Nonobese group | Experimental | Subjects will have blood drawn at 1900 hr for baseline hormone measurements. At 2200 hr each subject will take a single oral dose of dexamethasone at 2200 hr. At 0700 hr the following day, subjects will have a blood sample drawn for hormone measurements. After this blood sample, adrenocorticotropin (ACTH) will be administered as an iv bolus. At 30 and 60 minutes after ACTH, blood samples will be obtained for repeat hormone measurements. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adrenocorticotropin | Drug | Subjects will have blood drawn at 1900 hr for baseline hormone measurements. At 2200 hr each subject will take a single oral dose of dexamethasone at 2200 hr. At 0700 hr the following day, subjects will have a blood sample drawn for hormone measurements. After this blood sample, adrenocorticotropin (ACTH) will be administered as an iv bolus. At 30 and 60 minutes after Cosyntropin, blood samples will be obtained for repeat hormone measurements. |
| Measure | Description | Time Frame |
|---|---|---|
| 17-hydroxyprogesterone Response to ACTH | 17-hyrooxyprogesterone levels before and after ACTH | 0 and 60 minutes after ACTH administration |
| Measure | Description | Time Frame |
|---|---|---|
| Free Testosterone Response to ACTH | Free Testosteorne levels before and after ACTH | 0 and 60 min after ACTH administration |
| Androstenedione Response to ACTH | Androstenedione levels before and after ACTH |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| R J Chang, MD | UCSD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of california, san diego | La Jolla | California | 92037 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Early Puberty Group | Subjects were subdivided into normal weight and overweight groups. Blood was drawn at 1900 hr for baseline measurements. At 2200 hr each subject will take dexamethasone. At 0700 hr the following day, subjects will have a blood drawn for hormone measurements. After this adrenocorticotropin (ACTH) will be administered. At 30 and 60 minutes after ACTH, blood will be obtained for repeat hormone measurements. Adrenocorticotropin: Subjects will have blood drawn at 1900 hr for baseline measurements. At 2200 hr each subject will take a oral dose of dexamethasone at 2200 hr. At 0700 hr the following day, subjects will have a blood drawn for hormone measurements. After this blood sample, adrenocorticotropin (ACTH) will be administered. At 30 and 60 minutes after Cosyntropin, blood will be obtained for repeat hormone measurements. |
| FG001 | Late Puberty Group | Subjects were subdivided into normal weight and overweight groups. Subjects will have blood drawn at 1900 hr for baseline measurements. At 2200 hr each subject will take dexamethasone. At 0700 hr the following day, subjects will have a blood drawn for hormone measurements. After this adrenocorticotropin (ACTH) will be administered. At 30 and 60 minutes after ACTH, blood will be obtained for repeat hormone measurements. Adrenocorticotropin: Subjects will have blood drawn at 1900 hr for baseline hormone measurements. At 2200 hr each subject will take dexamethasone. At 0700 hr the following day, subjects will have a blood drawn for hormone measurements. After this blood sample, adrenocorticotropin (ACTH) will be administered. At 30 and 60 minutes after Cosyntropin, blood samples will be obtained for repeat hormone measurements. Dex |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Early Puberty Group | Subjects were subdivided into normal weight and overweight groups. Subjects will have blood drawn at 1900 hr for baseline measurements. At 2200 hr each subject will take dexamethasone. At 0700 hr the following day, subjects will have a blood drawn for hormone measurements. After this adrenocorticotropin (ACTH) will be administered as an iv bolus. At 30 and 60 minutes after ACTH, blood will be obtained for repeat hormone measurements. Adrenocorticotropin: Subjects will have blood drawn at 1900 hr for baseline hormone measurements. At 2200 hr each subject will take a oral dose of dexamethasone at 2200 hr. At 0700 hr the following day, subjects will have a blood drawn for hormone measurements. After this, adrenocorticotropin (ACTH) will be administered. At 30 and 60 minutes after Cosyntropin, blood samples will be obtained for repeat hormone measurements. Dex |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | 17-hydroxyprogesterone Response to ACTH | 17-hyrooxyprogesterone levels before and after ACTH | Analysis is performed on a normal weight group comprised of 4 early puberty and 10 late puberty girls and an overweight group of 6 early puberty and 30 late puberty girls | Posted | Mean | Standard Error | ng/mL | 0 and 60 minutes after ACTH administration |
|
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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 | Early Puberty | Subjects will have blood drawn at 1900 hr for baseline hormone measurements. At 2200 hr each subject will take a single oral dose of dexamethasone at 2200 hr. At 0700 hr the following day, subjects will have a blood sample drawn for hormone measurements. After this blood sample, adrenocorticotropin (ACTH) will be administered as an iv bolus. At 30 and 60 minutes after ACTH, blood samples will be obtained for repeat hormone measurements. Adrenocorticotropin: Subjects will have blood drawn at 1900 hr for baseline hormone measurements. At 2200 hr each subject will take a single oral dose of dexamethasone at 2200 hr. At 0700 hr the following day, subjects will have a blood sample drawn for hormone measurements. After this blood sample, adrenocorticotropin (ACTH) will be administered as an iv bolus. At 30 and 60 minutes after Cosyntropin, blood samples will be obtained for repeat hormone measurements. . |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. R. Jeffery Chang | UCSD | 858-534-8930 | rjchang@ucsd.edu |
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| ID | Term |
|---|---|
| D000324 | Adrenocorticotropic Hormone |
| D003366 | Cosyntropin |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D053486 | Melanocortins |
| D011333 | Pro-Opiomelanocortin |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
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|
|
| Dexamethasone | Drug | Subjects will have blood drawn at 1900 hr for baseline hormone measurements. At 2200 hr each subject will take a single oral dose of dexamethasone at 2200 hr. At 0700 hr the following day, subjects will have a blood sample drawn for hormone measurements. After this blood sample, 0.25 mg adrenocorticotropin (ACTH) will be administered as an iv bolus. At 30 and 60 minutes after Cosyntropin, blood samples will be obtained for repeat hormone measurements. |
|
|
| 0 and 60 min after ACTH administration |
| BG001 | Late Puberty Group | Subjects were further subdivided into normal weight and overweight groups. Subjects will have blood drawn at 1900 hr for baseline measurements. At 2200 hr each subject will take dexamethasone. At 0700 hr the following day, subjects will have a blood drawn for hormone measurements. After this, adrenocorticotropin (ACTH) will be administered. At 30 and 60 minutes after ACTH, blood will be obtained for repeat hormone measurements. Adrenocorticotropin: Subjects will have blood drawn at 1900 hr for baseline hormone measurements. At 2200 hr each subject will take dexamethasone at 2200 hr. At 0700 hr the following day, subjects will have a blood drawn for hormone measurements. After this, adrenocorticotropin (ACTH) will be administered as an iv bolus. At 30 and 60 minutes after Cosyntropin, blood samples will be obtained for repeat hormone measurements. Dex |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| OG001 | Late Puberty Group | Subjects were further subdivided into normal weight and overweight groups. Subjects will have blood drawn at 1900 hr for baseline hormone measurements. At 2200 hr each subject will take a single oral dose of dexamethasone at 2200 hr. At 0700 hr the following day, subjects will have a blood sample drawn for hormone measurements. After this blood sample, adrenocorticotropin (ACTH) will be administered as an iv bolus. At 30 and 60 minutes after ACTH, blood samples will be obtained for repeat hormone measurements. |
| OG002 | Total Number | Subjects will have blood drawn at 1900 hr for baseline hormone measurements. At 2200 hr each subject will take a single oral dose of dexamethasone at 2200 hr. At 0700 hr the following day, subjects will have a blood sample drawn for hormone measurements. After this blood sample, adrenocorticotropin (ACTH) will be administered as an iv bolus. At 30 and 60 minutes after ACTH, blood samples will be obtained for repeat hormone measurements. Adrenocorticotropin: Subjects will have blood drawn at 1900 hr for baseline hormone measurements. At 2200 hr each subject will take a single oral dose of dexamethasone at 2200 hr. At 0700 hr the following day, subjects will have a blood sample drawn for hormone measurements. After this blood sample, adrenocorticotropin (ACTH) will be administered as an iv bolus. At 30 and 60 minutes after Cosyntropin, blood samples will be obtained for repeat hormone measurements. Dex |
|
|
| Secondary | Free Testosterone Response to ACTH | Free Testosteorne levels before and after ACTH | Analysis is performed on a normal weight group comprised of 4 early puberty and 10 late puberty girls and an overweight group of 6 early puberty and 30 late puberty girls | Posted | Mean | Standard Error | pmol/L | 0 and 60 min after ACTH administration |
|
|
|
| Secondary | Androstenedione Response to ACTH | Androstenedione levels before and after ACTH | Analysis is performed on a normal weight group comprised of 4 early puberty and 10 late puberty girls and an overweight group of 6 early puberty and 30 late puberty girls | Posted | Mean | Standard Error | ng/mL | 0 and 60 min after ACTH administration |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Late Puberty | Subjects will have blood drawn at 1900 hr for baseline hormone measurements. At 2200 hr each subject will take a single oral dose of dexamethasone at 2200 hr. At 0700 hr the following day, subjects will have a blood sample drawn for hormone measurements. After this blood sample, adrenocorticotropin (ACTH) will be administered as an iv bolus. At 30 and 60 minutes after ACTH, blood samples will be obtained for repeat hormone measurements. Adrenocorticotropin: Subjects will have blood drawn at 1900 hr for baseline hormone measurements. At 2200 hr each subject will take a single oral dose of dexamethasone at 2200 hr. At 0700 hr the following day, subjects will have a blood sample drawn for hormone measurements. After this blood sample, adrenocorticotropin (ACTH) will be administered as an iv bolus. At 30 and 60 minutes after Cosyntropin, blood samples will be obtained for repeat hormone measurements. | 0 | 40 | 0 | 40 | 0 | 40 |
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| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| Overweight |
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| Overweight |
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