Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Regulation of Cortisol Metabolism and Fat Patterning
This study is currently recruiting participants.
Verified by Oregon Health and Science University, June 2008
Sponsors and Collaborators: Oregon Health and Science University
National Institutes of Health (NIH)
Information provided by: Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT00694733
  Purpose

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 Intervention
Obesity
Menopause
Drug: Placebo injection
Drug: Depo Lupron/Aromatase inhibitor
Drug: Depo Lupron/placebo
Drug: placebo
Drug: Estrogen cream

MedlinePlus related topics: Obesity
Drug Information available for: Hydrocortisone Cortisol 21-phosphate Cortisol succinate Hydrocortamate Hydrocortisone 21-sodium succinate Hydrocortisone acetate Hydrocortisone cypionate Hydrocortisone hemisuccinate Proctofoam-HC Testosterone Methyltestosterone Oxymesterone Testosterone enanthate Testosterone Propionate Testosterone undecanoate Anastrozole Depogen Estradiol Estradiol 3-benzoate Estradiol acetate Estradiol cypionate Estradiol dipropionate Estradiol valerate Polyestradiol phosphate Leuprolide acetate Leuprolide Benzocaine
U.S. FDA Resources
Study Type: Interventional
Study Design: Basic Science, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Pharmacokinetics/Dynamics Study
Official Title: Regulation of Cortisol Metabolism and Fat Patterning

Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: May 2005
Estimated Study Completion Date: September 2008
Estimated Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Placebo Comparator
Men on placebo injections for 4 months
Drug: Placebo injection
Normal saline injection IM monthly for 4 months
2: Active Comparator
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.
3: Active Comparator
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.
4: Placebo Comparator
Women on placebo cream
Drug: placebo
Placebo Cream 1ml applied twice daily for four months
5: Active Comparator
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.

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

Ages Eligible for Study:   18 Years to 62 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00694733

Contacts
Contact: Jonathan Q. Purnell, M.D. 503-494-1056 purnellj@ohsu.edu
Contact: Bethany Klopfenstein, M.D. 503-494-4020 klopfens@ohsu.edu

Locations
United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Jonathan Q. Purnell, M.D.     503-494-1056     purnellj@ohsu.edu    
Contact: Bethany Klopfenstein, M.D.     503-494-4020     klopfens@ohsu.edu    
Principal Investigator: Jonanthan Q Purnell, M.D.            
Sponsors and Collaborators
Oregon Health and Science University
Investigators
Principal Investigator: Jonathan Q. Purnell, M.D. OHSU - Center for the Study of Weight Regulation
  More Information

Responsible Party: OHSU - Center for the Study of Weight Regulation ( Jonanthan Q. Purnell )
Study ID Numbers: eIRB #937, OCTRI #862
Study First Received: June 6, 2008
Last Updated: June 9, 2008
ClinicalTrials.gov Identifier: NCT00694733  
Health Authority: United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:
Obesity
Menopause
Cortisol

Study placed in the following topic categories:
Obesity
Anastrozole
Hydrocortisone
Cortisol succinate
Estradiol valerate
Benzocaine
Overweight
Estradiol 17 beta-cypionate
Methyltestosterone
Estradiol
Testosterone 17 beta-cypionate
Body Weight
Signs and Symptoms
Testosterone
Leuprolide
Estradiol 3-benzoate
Nutrition Disorders
Overnutrition
Hydrocortisone acetate
Polyestradiol phosphate
Menopause

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Fertility Agents, Female
Therapeutic Uses
Physiological Effects of Drugs
Fertility Agents
Reproductive Control Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009