The Adrenal Contribution to Androgen Production in Girls During Puberty
Condition: Development
Intervention: Adrenocorticotropin; Dexamethasone
Intervention description: 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.; 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.
Intervention MeSH terms: Dexamethasone; Cosyntropin; Adrenocorticotropic Hormone; Melanocyte-Stimulating Hormones; beta-Endorphin
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: Female
Minimum age: 7 Years
Maximum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: adolescents; puberty; androgens; hyperandrogenemia

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Normal CBC (Hemoglobin must be at least 11mg/dl)

          -  Normal renal and liver function tests (AST& ALT 10-45 IU/L; Albumin 3.3-5 g/dL; Alk
             phos 30-130 IU/L;

          -  direct bili <0.2 mg/dL;

          -  total bili <1.2 mg/dL; total protein 6.0-8.0 g/dL) Normal vital signs including normal
             blood pressure (pulse 60-100/min, respirations 12-20/min, BP 80/60-130/80)

        Exclusion Criteria:

          -  Pregnancy

          -  On oral contraceptives

          -  On insulin lowering drugs

          -  On anti-androgens (i.e., spironolactone, flutamide, finasteride, etc)

          -  On medications that will influence androgen metabolism or clearance

          -  On medications that will inhibit the cytochrome P450 enzyme system (cimetidine,
             ketoconazole, etc)

          -  Subjects with morning cortisol<5 ug/dL will be excluded and asked to see their primary
             care physician.

          -  Subjects with 17-OHP>250 ng/dL) will be excluded and asked to see their primary care
             physician.

          -  Subject with a history of Cushing syndrome or adrenal insufficiency will be excluded