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Regulation of Cortisol Metabolism and Fat Patterning | Clinical Trials | Clareo Health

UNKNOWNNA

Regulation of Cortisol Metabolism and Fat Patterning

NCT00694733•Oregon Health and Science University

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).

Eligibility

Age

18 - 62 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•40 postmenopausal women (age 40-62) and 30 men (age 18-45) will be recruited if they are healthy, at their lifetime maximal weight, have been weight stable for at least six months prior to entry, have a BMI between 19 and 39.9 kg/m2, and be willing to commit to not making significant changes to their diet or daily activities while enrolled in the study.

Exclusion Criteria

•Subjects will be excluded for potential confounders on body weight, cortisol production rates, sex steroid metabolism, or contraindications to strong magnetic fields:
•1. Age less than 18 to exclude those who might be experiencing alterations in cortisol production or weight as a result of adolescent growth
•2. Subjects who exercise \> 30 minutes/day, 3 times a week
•3. Smokers
•4. Heavy alcohol drinkers (\> 2 drinks/ day)
•5. Subjects with medical diagnosis including diabetes, heart disease, and cancer
•6. Subjects with psychiatric illness (i.e., depression, psychosis, bipolar, schizophrenia; or are taking medications for these disorders)
•7. BMI 40 kg/m2, since obesity influences levels of sex steroids and sex hormone binding globulin; or body weight \> 136 kg (300 lbs), since this is the weight limit for the DEXA and MR machines
•8. Presence of metal in the body such as body piercing, shrapnel, cardiac pacemakers or aneurysm clips
•9. Endocrine diseases affecting body composition, such as untreated hypothyroidism or Cushing's syndrome, will be excluded by history and physical examination, or by laboratory evaluation if necessary.
+7 more criteria

Locations (1)

Oregon Health & Science University

Portland, Oregon, United States

Key Dates

Start Date

May 1, 2005

Primary Completion Date

March 1, 2024

Completion Date

September 1, 2024

Last Updated

December 16, 2022

Enrollment

140

ACTUAL participants

Conditions

ObesityMenopausal Syndrome

Interventions

Placebo injection

DRUG

Depo Lupron/Aromatase inhibitor

DRUG

Depo Lupron/placebo

DRUG

placebo

DRUG

Estrogen cream

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 16, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Regulation of Cortisol Metabolism and Fat Patterning

Inclusion Criteria

Exclusion Criteria

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