Effects of Androgen Administration on Inflammation in Normal Women

November 14, 2013 updated by: Frank Gonzalez, Mayo Clinic

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
0 and 2 hours after glucose ingestion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insulin sensitivity
Time Frame: 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.
0 and 5 days after DHEA or placebo

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Frank González, M.D., Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

December 15, 2012

First Submitted That Met QC Criteria

December 15, 2012

First Posted (Estimate)

December 20, 2012

Study Record Updates

Last Update Posted (Estimate)

November 18, 2013

Last Update Submitted That Met QC Criteria

November 14, 2013

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Mayo-06-004680

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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