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Regulation of Cortisol Metabolism and Fat Patterning

NCT ID: NCT00694733

Last Updated: 2022-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Study Completion Date

2024-09-30

Brief Summary

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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

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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

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Obesity Menopausal Syndrome

Keywords

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Obesity Menopausal Syndrome Cortisol

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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1

Men on placebo injections for 4 months

Group Type PLACEBO_COMPARATOR

Placebo injection

Intervention Type DRUG

Normal saline injection IM monthly for 4 months

2

Men who receive Depo Lupron for 4 months, then are replaced with testosterone and aromatase inhibitor for 4 months.

Group Type ACTIVE_COMPARATOR

Depo Lupron/Aromatase inhibitor

Intervention Type DRUG

Depo Lupron injection 7.5mg IM monthly for 8 months, with addition of testosterone gel and aromatase inhibitor months 4-8.

3

Men who receive Depo Lupron for 4 months, then are replaced with testosterone and placebo for 4 months.

Group Type ACTIVE_COMPARATOR

Depo Lupron/placebo

Intervention Type DRUG

Depo Lupron injection 7.5mg IM monthly for 8 months, with addition of testosterone gel and placebo months 4-8.

4

Women on placebo cream

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Placebo Cream 1ml applied twice daily for four months

5

Women on estrogen cream

Group Type ACTIVE_COMPARATOR

Estrogen cream

Intervention Type DRUG

Estrogen cream 1 ml twice daily, dose titrated to maintain estradiol level between 60 and 280 pg/ml.

Interventions

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Placebo injection

Normal saline injection IM monthly for 4 months

Intervention Type 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.

Intervention Type DRUG

Depo Lupron/placebo

Depo Lupron injection 7.5mg IM monthly for 8 months, with addition of testosterone gel and placebo months 4-8.

Intervention Type DRUG

placebo

Placebo Cream 1ml applied twice daily for four months

Intervention Type DRUG

Estrogen cream

Estrogen cream 1 ml twice daily, dose titrated to maintain estradiol level between 60 and 280 pg/ml.

Intervention Type DRUG

Other Intervention Names

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Normal Saline Depo-Lupron Testim 1% gel Anastrozole Arimidex Depo-Lupron Testim 1% gel Placebo capsules Placebo cream Estradiol cream

Eligibility Criteria

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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.
* Women with a contraindication to estrogen use will also be excluded, including: an estrogen dependent malignancy, active thrombophlebitis, history of deep venous thrombosis, hypertriglyceridemia, untreated hypertension, cardiovascular disease, migraine headaches, or current tobacco use.
* Women with frequent hot flashes or disrupted sleep will also be excluded since they will be unlikely to tolerate randomization to placebo and continued symptoms and altered sleep cycles will independently affect cortisol secretion patterns.
* All volunteers will have had a normal mammogram within the previous 12 months.
* Any subject with previously unevaluated postmenopausal bleeding will not be included and, instead, will be referred to a physician for evaluation.
* Women who underwent surgical menopause (bilateral ovariectomy) must be at least one year out from their surgery before considered eligible so as to allow weight stabilization after the procedure.
* Men will have had a prostate exam by their primary health provider within the previous year or by the PI at the time of screening for this study.
* Any subjects taking a blood thinning medication or with an abnormal exam will not be included and, instead, will be referred to a physician for evaluation
Minimum Eligible Age

18 Years

Maximum Eligible Age

62 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

Oregon Health and Science University

OTHER

Sponsor Role lead

Responsible Party

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Jonathan Purnell

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jonathan Q. Purnell, M.D.

Role: PRINCIPAL_INVESTIGATOR

OHSU - Center for the Study of Weight Regulation

Locations

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Oregon Health & Science University

Portland, Oregon, United States

Site Status

Countries

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United States

Other Identifiers

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OCTRI #862

Identifier Type: OTHER

Identifier Source: secondary_id

eIRB #937

Identifier Type: -

Identifier Source: org_study_id