ObesityNCT00694733
Regulation of Cortisol Metabolism and Fat Patterning
A study testing Depo Lupron/Aromatase inhibitor and Estrogen cream in people with Obesity and Menopausal Syndrome, run by Oregon Health and Science University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 62 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Menopausal Syndrome
- What is being tested?
- Depo Lupron/Aromatase inhibitor and Estrogen cream
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- May 2005to Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 62 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Subjects will be excluded for potential confounders on body weight, cortisol production rates, sex steroid metabolism, or contraindications to strong magnetic fields:
- Age less than 18 to exclude those who might be experiencing alterations in cortisol production or weight as a result of adolescent growth
- Subjects who exercise > 30 minutes/day, 3 times a week
- Smokers
- Heavy alcohol drinkers (> 2 drinks/ day)
- Subjects with medical diagnosis including diabetes, heart disease, and cancer
Show all 17Show fewer
- Subjects with psychiatric illness (i.e., depression, psychosis, bipolar, schizophrenia; or are taking medications for these disorders)
- 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
- Presence of metal in the body such as body piercing, shrapnel, cardiac pacemakers or aneurysm clips
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
The purpose of this study is to determine if estrogen or testosterone can affect cortisol levels and where fat builds up in our bodies.
Read the 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).
- Conditions
- Obesity, Menopausal Syndrome
- Being tested
- Placebo injection, Depo Lupron/Aromatase inhibitor, Depo Lupron/placebo, placebo, Estrogen cream
- Keywords
- Obesity, Menopausal Syndrome, Cortisol
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo injectionDrug
Also called Normal Saline
Normal saline injection IM monthly for 4 months
Depo Lupron/Aromatase inhibitorDrug
Also called Depo-Lupron, Testim 1% gel, Anastrozole, Arimidex
Depo Lupron injection 7.5mg IM monthly for 8 months, with addition of testosterone gel and aromatase inhibitor months 4-8.
Depo Lupron/placeboDrug
Also called Depo-Lupron, Testim 1% gel, Placebo capsules
Depo Lupron injection 7.5mg IM monthly for 8 months, with addition of testosterone gel and placebo months 4-8.
placeboDrug
Also called Placebo cream
Placebo Cream 1ml applied twice daily for four months
Estrogen creamDrug
Also called Estradiol cream
Estrogen cream 1 ml twice daily, dose titrated to maintain estradiol level between 60 and 280 pg/ml.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Men on placebo injections for 4 months Receives: Drug: Placebo injection |
| 2 | Active comparator | Men who receive Depo Lupron for 4 months, then are replaced with testosterone and aromatase inhibitor for 4 months. Receives: Drug: Depo Lupron/Aromatase inhibitor |
| 3 | Active comparator | Men who receive Depo Lupron for 4 months, then are replaced with testosterone and placebo for 4 months. Receives: Drug: Depo Lupron/placebo |
| 4 | Placebo comparator | Women on placebo cream Receives: Drug: placebo |
| 5 | Active comparator | Women on estrogen cream Receives: Drug: Estrogen cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Before and after hormone replacement therapy
Secondary outcomes (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.
Measured: Before and after hormone replacement therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2008 (estimated)
- Study startMay 2005
- Primary completionMar 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan Purnell, Oregon Health and Science University
- Investigators
- Jonathan Q. Purnell, M.D., Principal investigator, OHSU - Center for the Study of Weight Regulation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00694733
- Sponsor's protocol ID
- eIRB #937
- Other IDs
- OCTRI #862
- Status last verified
- Dec 2022
- First submitted
- 6 Jun 2008
- Last updated
- 16 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regulation of Cortisol Metabolism and Fat Patterning
- ClinicalTrials.gov ID
- NCT00694733
- Acronym / sponsor ID
- eIRB #937
- Conditions
- Obesity, Menopausal Syndrome
- Keywords
- Obesity, Menopausal Syndrome, Cortisol
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- May 2005
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 10 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: Placebo injectionMen on placebo injections for 4 months |
| 2 | Active comparator | Drug: Depo Lupron/Aromatase inhibitorMen who receive Depo Lupron for 4 months, then are replaced with testosterone and aromatase inhibitor for 4 months. |
| 3 | Active comparator | Drug: Depo Lupron/placeboMen who receive Depo Lupron for 4 months, then are replaced with testosterone and placebo for 4 months. |
| 4 | Placebo comparator | Drug: placeboWomen on placebo cream |
| 5 | Active comparator | Drug: Estrogen creamWomen on estrogen cream |
Who may qualify
- Ages
- 18 to 62 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (17 listed)
- Subjects will be excluded for potential confounders on body weight, cortisol production rates, sex steroid metabolism, or contraindications to strong magnetic fields:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo injectionAlso: Normal SalineNormal saline injection IM monthly for 4 months | Drug | 1 |
| Depo Lupron/Aromatase inhibitorAlso: Depo-Lupron, Testim 1% gel, Anastrozole, ArimidexDepo Lupron injection 7.5mg IM monthly for 8 months, with addition of testosterone gel and aromatase inhibitor months 4-8. | Drug | 2 |
| Depo Lupron/placeboAlso: Depo-Lupron, Testim 1% gel, Placebo capsulesDepo Lupron injection 7.5mg IM monthly for 8 months, with addition of testosterone gel and placebo months 4-8. | Drug | 3 |
| placeboAlso: Placebo creamPlacebo Cream 1ml applied twice daily for four months | Drug | 4 |
| Estrogen creamAlso: Estradiol creamEstrogen cream 1 ml twice daily, dose titrated to maintain estradiol level between 60 and 280 pg/ml. | Drug | 5 |
Primary outcome
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan Q. Purnell, M.D. principal investigator
OHSU - Center for the Study of Weight Regulation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Depo Lupron/Aromatase inhibitor and Estrogen cream in people with Obesity and Menopausal Syndrome, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2022.