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Regulation of Cortisol Metabolism and Fat Patterning

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ClinicalTrials.gov Identifier: NCT00694733
Recruitment Status : Completed
First Posted : June 10, 2008
Last Update Posted : June 6, 2012
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment
Obesity Menopausal Syndrome Drug: Placebo injection Drug: Depo Lupron/Aromatase inhibitor Drug: Depo Lupron/placebo Drug: placebo Drug: Estrogen cream

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).

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Regulation of Cortisol Metabolism and Fat Patterning
Study Start Date : May 2005
Primary Completion Date : March 2009
Study Completion Date : September 2009

Arms and Interventions

Arm Intervention/treatment
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.
Other Names:
  • Depo-Lupron
  • Testim 1% gel
  • Anastrozole
  • Arimidex
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.
Other Names:
  • Depo-Lupron
  • Testim 1% gel
  • Placebo capsules
Placebo Comparator: 4
Women on placebo cream
Drug: placebo
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

Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 62 Years   (Adult)
Sexes Eligible for Study:   All
Accepts 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.
  • 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
Contacts and Locations

Information from the National Library of Medicine

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
Sponsors and Collaborators
Oregon Health and Science University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Jonathan Q. Purnell, M.D. OHSU - Center for the Study of Weight Regulation
More Information

Responsible Party: Jonathan Purnell, Principal Investigator, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT00694733     History of Changes
Other Study ID Numbers: eIRB #937
OCTRI #862 ( Other Identifier: Oregon Health and Sciences University )
First Posted: June 10, 2008    Key Record Dates
Last Update Posted: June 6, 2012
Last Verified: June 2012

Keywords provided by Jonathan Purnell, Oregon Health and Science University:
Menopausal Syndrome

Additional relevant MeSH terms:
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Aromatase Inhibitors
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Cortisol succinate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Anti-Inflammatory Agents
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents