Effects of Androgen Administration on Inflammation in Normal Women
|ClinicalTrials.gov Identifier: NCT01753037|
Recruitment Status : Completed
First Posted : December 20, 2012
Last Update Posted : November 18, 2013
|Condition or disease||Intervention/treatment||Phase|
|Hyperandrogenism||Dietary Supplement: Dehydroepiandrosterone (DHEA) Other: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|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 :||December 2006|
|Actual Primary Completion Date :||April 2010|
|Actual Study Completion Date :||April 2010|
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.
Placebo contained in a capsule that is identical in appearance to the one used to package DHEA for 5 days.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01753037
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Frank González, M.D.||Mayo Clinic|