Clinical Trial: Effects of Androgen Administration on Inflammation in Normal Women

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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.

Detailed Summary:
Sponsor: Mayo Clinic

Current Primary Outcome: 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.


Original Primary Outcome: Nuclear factor kappa B (NFkappaB) activation [ Time Frame: 1 year ]

White blood cell NFkappaB activation in response to glucose ingestion before and after five days of DHEA administration will be assessed in all subjects.


Current Secondary Outcome: 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.


Original Secondary Outcome: Insulin sensitivity [ Time Frame: 1 year ]

Insulin sensitivity derived from an oral glucose tolerance test (OGTT) before and after five days of DHEA administration will be assessed in all subjects.


Information By: Mayo Clinic

Dates:
Date Received: December 15, 2012
Date Started: December 2006
Date Completion:
Last Updated: November 14, 2013
Last Verified: December 2012