Regulation of Cortisol Metabolism and Fat Patterning
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|ClinicalTrials.gov Identifier: NCT00694733|
Recruitment Status : Active, not recruiting
First Posted : June 10, 2008
Last Update Posted : August 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Obesity Menopausal Syndrome||Drug: Placebo injection Drug: Depo Lupron/Aromatase inhibitor Drug: Depo Lupron/placebo Drug: placebo Drug: Estrogen cream||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||140 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Basic Science|
|Official Title:||Regulation of Cortisol Metabolism and Fat Patterning|
|Study Start Date :||May 2005|
|Estimated Primary Completion Date :||March 2020|
|Estimated Study Completion Date :||September 2020|
Placebo Comparator: 1
Men on placebo injections for 4 months
Drug: Placebo injection
Normal saline injection IM monthly for 4 months
Other Name: Normal Saline
Active Comparator: 2
Men who receive Depo Lupron for 4 months, then are replaced with testosterone and aromatase inhibitor 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.
Active Comparator: 3
Men who receive Depo Lupron for 4 months, then are replaced with testosterone and placebo for 4 months.
Drug: Depo Lupron/placebo
Depo Lupron injection 7.5mg IM monthly for 8 months, with addition of testosterone gel and placebo months 4-8.
Placebo Comparator: 4
Women on placebo cream
Placebo Cream 1ml applied twice daily for four months
Other Name: Placebo cream
Active Comparator: 5
Women on estrogen cream
Drug: Estrogen cream
Estrogen cream 1 ml twice daily, dose titrated to maintain estradiol level between 60 and 280 pg/ml.
Other Name: Estradiol cream
- To measure 24-hour CPR, free cortisol, and cortisol binding globulin levels in plasma; HSD 1 activity, glucocorticoid receptor binding, and cortisol levels in adipocytes; and urinary excretion of cortisol, cortisone and their metabolites. [ Time Frame: Before and after hormone replacement therapy ]
- To measure intramyocellular fat and intrahepatic fat by MRS, visceral and subcutaneous abdominal fat by CT scan, body composition (fat mass, lean mass, and bone mass) by DXA, and insulin sensitivity. [ Time Frame: Before and after hormone replacement therapy ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00694733
|United States, Oregon|
|Oregon Health & Science University|
|Portland, Oregon, United States, 97239|
|Principal Investigator:||Jonathan Q. Purnell, M.D.||OHSU - Center for the Study of Weight Regulation|