Hyperandrogenism
Conditions
Keywords
Hyperandrogenism, Inflammation, Insulin sensitivity, Body composition
Brief summary
The hypothesis of this study is that DHEA administration to increase male hormone in healthy normal-weight young women to levels present in women with Polycystic Ovary Syndrome will cause an inflammatory response in white blood cells in the fasting state, and in response to glucose ingestion.
Interventions
DIETARY_SUPPLEMENTDehydroepiandrosterone (DHEA)
DHEA 130 mg administered orally for 5 days.
OTHERPlacebo
Placebo contained in a capsule that is identical in appearance to the one used to package DHEA for 5 days.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Acceptable health based on interview, medical history, physical examination and lab tests * Ability to comply with requirements of the study * Ability and willingness to provide signed, witnessed informed consent * Between the ages of 18-40 years * Body mass index between 18 and 25 * Normal regular monthly periods * No clinical evidence of androgen excess * No evidence of polycystic ovaries on ultrasound
Exclusion criteria
* Diabetes mellitus * Clinically significant pulmonary, cardiac, renal, hepatic, neurologic, psychiatric, infectious and malignant disease * High blood pressure * Current or recent (within 30 days prior to study entry) use of any drugs known or suspected to affect reproductive function including oral contraceptives, metformin, gonadotropin releasing hormone agonists, or anti-androgens (spironolactone, flutamide, etc.) * Use of medications that have an adverse drug interaction with DHEA therapy including antipsychotics, phenothiazines, lithium, selective serotonin reuptake inhibitors, triazolam, estrogen or testosterone formulations * Known hypersensitivity to DHEA * Two first-degree relatives with breast cancer or ovarian cancer * Documented or suspected history of recent (within 1 year) illicit drug abuse or alcoholism * Tobacco smoking * Ingestion of any investigational drugs within 4 weeks prior to study onset * Pregnancy or lactation (less than or equal to 6 weeks postpartum)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nuclear factor kappa B (NFkappaB) activation | 0 and 2 hours after glucose ingestion | White blood cell NFkappaB activation will be assessed in response to glucose ingestion before and after 5 days of DHEA or placebo administration. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Insulin sensitivity | 0 and 5 days after DHEA or placebo | Insulin sensitivity derived from an oral glucose tolerance test (OGTT) will be assessed before and after 5 days of DHEA or placebo administration. |
Countries
United States
Outcome results
None listed