Effects of Androgen Administration on Inflammation in Normal Women

Sponsor

Mayo Clinic (Other)

Overall Status

Completed

CT.gov ID

NCT01753037

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hyperandrogenism	Dietary Supplement: Dehydroepiandrosterone (DHEA) Other: Placebo	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

25 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Basic Science

Official Title:

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

Study Start Date :

Dec 1, 2006

Actual Primary Completion Date :

Apr 1, 2010

Actual Study Completion Date :

Apr 1, 2010

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: DHEA Group

Oral administration of a capsule containing 130 mg of dehydroepiandrosterone (DHEA) for 5 days.

Dietary Supplement: Dehydroepiandrosterone (DHEA)

DHEA 130 mg administered orally for 5 days.

Placebo Comparator: Placebo Group

Oral administration of an identical capsule containing placebo for 5 days.

Other: Placebo

Placebo contained in a capsule that is identical in appearance to the one used to package DHEA for 5 days.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

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)