Effects of Oral Androgen Administration on Hyperglycemia-Induced Inflammation in Lean Reproductive-Age Women
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Mayo Clinic
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Nuclear factor kappa B (NFkappaB) activation
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- Female
- Accepts 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)
Arms & Interventions
Placebo Group
Oral administration of an identical capsule containing placebo for 5 days.
Intervention: Placebo (Other)
DHEA Group
Oral administration of a capsule containing 130 mg of dehydroepiandrosterone (DHEA) for 5 days.
Intervention: Dehydroepiandrosterone (DHEA) (Dietary Supplement)
Outcomes
Primary Outcomes
Nuclear factor kappa B (NFkappaB) activation
Time Frame: 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 Outcomes
- Insulin sensitivity(0 and 5 days after DHEA or placebo)
Investigators
Frank Gonzalez
Study Principal Investigator
Mayo Clinic