NCT00694733

Regulation of Cortisol Metabolism and Fat Patterning

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: Oregon Health and Science University · Academic / Other
• Sex: All
• Age: 18 Years – 62 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine if estrogen or testosterone can affect cortisol levels and where fat builds up in our bodies.

Detailed description

Subjects will be studied 3 or 4 times on the inpatient unit of the Oregon Clinical and Translational Research Center. During each visit, testing will include measuring the amount of whole body fat and fat in the stomach area, muscle, and liver; levels of cortisol in the blood, urine, and fat tissue (taken from a biopsy); how well insulin works (insulin sensitivity).

Conditions

• Obesity
• Menopausal Syndrome

Interventions

Type	Name	Description
DRUG	Placebo injection	Normal saline injection IM monthly for 4 months
DRUG	Depo Lupron/Aromatase inhibitor	Depo Lupron injection 7.5mg IM monthly for 8 months, with addition of testosterone gel and aromatase inhibitor months 4-8.
DRUG	Depo Lupron/placebo	Depo Lupron injection 7.5mg IM monthly for 8 months, with addition of testosterone gel and placebo months 4-8.
DRUG	placebo	Placebo Cream 1ml applied twice daily for four months
DRUG	Estrogen cream	Estrogen cream 1 ml twice daily, dose titrated to maintain estradiol level between 60 and 280 pg/ml.

Timeline

• Start date: 2005-05-01
• Primary completion: 2024-03-01
• Completion: 2024-09-01
• First posted: 2008-06-10
• Last updated: 2022-12-16

Locations

1 site across 1 country: United States