IRB Number:

06-004680

Trial Status:

Open for Enrollment

Phase: I

Why is this study being done?

Polycystic Ovary Syndrome (PCOS) is characterized by hyperandrogenism, chronic anovulation and polycystic ovarian morphology. Insulin resistance is a common finding in the disorder, and low grade chronic inflammation is currently considered to be a contributor to insulin resistance. Women with PCOS exhibit increased mononuclear cell (MNC) sensitivity characterized by upregulation of the inflammation pathway during physiological hyperglycemia that is independent of obesity, and highly correlated with circulating androgens. The cause of this increased sensitivity is unknown. The proposed research is a double-blind randomized placebo-controlled study of 16 lean reproductive age women without PCOS. Eight subjects receiving oral DHEA for 5 days will be compared to 8 controls receiving placebo. The primary hypothesis is that oral androgen administration to increase circulating androgens to levels present in women with PCOS, will upregulate the inflammation pathway in MNC during hyperglycemia. The primary specific aim is to examine the inflammation pathway in MNC during hyperglycemia in response to the high dose oral DHEA treatment. The approach involves evaluation of the inflammatory response of MNC during an oral glucose challenge before and after DHEA administration by measuring ROS generation, expression of protein markers of the inflammation pathway, activated nuclear factor kB (NFkB) and cytokine release from cultured MNC. It is our expectation that we will demonstrate a pronounced inflammatory response following DHEA administration. These results will be significant because they will determine whether excess circulating androgen as observed in PCOS, is a promoter of inflammation and thus, is responsible for the preactivation of MNC that can increase their sensitivity to hyperglycemia. This in turn will serve as a guide for designing future studies that examine androgen-induced MNC preactivation in PCOS at the molecular level.

Who is Eligible to Participate in the Study?

You may be eligible to participate in this study if:
-- You are age 18-40
-- You are healthy and of normal weight
-- You have regular menstrual periods
-- You are not pregnant and do not take birth control pills
-- You do not have acne or excessive facial/body hair (may be signs of hormone imbalance)

Minimum Age:

18

Maximum Age:

40

What is Involved With this Study?

The study involves two overnight stays at the Saint Marys Clinical Research Unit (former GCRC) and taking the study medication for five days, with blood draws during two glucose tolerance tests. Body composition including assessment of body fat will be performed by DEXA scanning during the initial overnight stay. Subjects will receive meals prepared by the CRU dietary staff for 3 days before each overnight stay.

How long will the Study run?

9 days

Who can I Contact for Additional Information on this Trial?

For more information, contact:
Janice Daniels, study coordinator
507-284-4600
daniels.janice@mayo.edu

What is/are the Locations of this Clinical Trial?

• Rochester, MN

Last updated: 06/15/2009