Effects of Androgen Administration on Inflammation in Normal Women

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Oral Androgen Administration on Hyperglycemia-Induced Inflammation in Lean Reproductive-Age Women

Conditions
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Hyperandrogenism

Intervention / Treatment
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* Dietary Supplement: Dehydroepiandrosterone (DHEA)
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: DHEA Group<br>Oral administration of a capsule containing 130 mg of dehydroepiandrosterone (DHEA) for 5 days. | Dietary Supplement: Dehydroepiandrosterone (DHEA)<br>* DHEA 130 mg administered orally for 5 days.<br>|
| Placebo Comparator: Placebo Group<br>Oral administration of an identical capsule containing placebo for 5 days. | Other: Placebo<br>* Placebo contained in a capsule that is identical in appearance to the one used to package DHEA for 5 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nuclear factor kappa B (NFkappaB) activation | White blood cell NFkappaB activation will be assessed in response to glucose ingestion before and after 5 days of DHEA or placebo administration. | 0 and 2 hours after glucose ingestion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin sensitivity | Insulin sensitivity derived from an oral glucose tolerance test (OGTT) will be assessed before and after 5 days of DHEA or placebo administration. | 0 and 5 days after DHEA or placebo | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hyperandrogenism, Inflammation, Insulin sensitivity, Body composition