Brown Adipose Tissue Activity in Pre- and Postmenopausal Women
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|ClinicalTrials.gov Identifier: NCT02927392|
Recruitment Status : Recruiting
First Posted : October 7, 2016
Last Update Posted : July 26, 2018
|Condition or disease||Intervention/treatment||Phase|
|Menopause Obesity||Drug: Leuprolide acetate||Not Applicable|
Participants will be asked to perform studies to measure resting metabolic rate and activity of brown adipose tissue or brown fat. Brown fat is different from regular "white fat" in that it produces heat and burns calories. The investigators will measure how active brown fat is at normal room temperature and after participants have been exposed to cold.
The study will last 5-6 hours. It will consist of measurements made in warm temperatures and then after a period of cold exposure. For the cold exposure part of the study, participants will be asked to wear a cooling suit for 3 hrs. Skin temperature is normally about 90º Fahrenheit. The cooling suit will adjust the water temperature until your skin temperature is about 82º Fahrenheit. The suit will cover the entire body except for the face, hands, and feet. Participants may feel cold while wearing the suit and you may shiver some, but based on past studies, any shivering should be minor.
Before and after the cooling suit is turned on, body scans will be performed using a procedure called positron emission tomography (PET). These scans do not use radiation. Before the PET scans, the investigators will infuse radioactive tracer into an arm. These tracers have a low dose of radiation and will show us where the brown fat is and how active it is. One PET scan will be performed at room temperature, and the second scan will be performed after the cooling suit has been worn for 3 hours. Two additional scans using computed tomography (CT) will be performed at end of the study. CT scans are like an x-ray, and use radiation. The radiation dose in the CT scan is much higher than the tracers. When the CT scans are combined with the PET scans, we can separate brown fat from white fat.
15 pre-menopausal women will be asked to volunteer for a follow up study. For 5 months, pre-menopausal women in this study will receive monthly injections that contain a study drug (leuprolide) that reduces estrogen to postmenopausal levels. This drug is approved by the FDA to reduce estrogen for the treatment of uterine fibroids and endometriosis, but is not approved for use in healthy women. In this study, the drug is being used to decrease hormones to determine if this reduces brown fat activity. 6 months after the first injection, these women will be asked to repeat the PET/CT studies.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||72 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||The Impact of Estrogen Status on the Biological Function of Brown Adipose Tissue in Women Measured Using Quantitative PET/CT|
|Study Start Date :||January 2017|
|Estimated Primary Completion Date :||August 2019|
|Estimated Study Completion Date :||August 2019|
Experimental: Pre-menopausal women
To determine if natural declines in endogenous E2 contribute to changes in BAT activity, the investigators will compare BAT activity in pre-and post-menopausal women. We will also explore whether suppression of ovarian hormones in pre-menopausal women (using leuprolide acetate) impairs BAT activity.
Drug: Leuprolide acetate
A subset of premenopausal women will receive GnRHAG (leuprolide acetate) 3.75 mg/mo by intramuscular injection every 4 weeks for 24 weeks (6 doses).
Other Name: Lupron
No Intervention: Post-menopausal women
To determine if natural declines in endogenous E2 contribute to changes in BAT activity, the investigators will compare BAT activity in pre-and post-menopausal women.
- Brown Adipose Tissue Volume [ Time Frame: 5-6 hrs ]Brown adipose tissue volume will be measured using the radioactive tracer 18Fluro-deoxyglucose.
- Brown Adipose Tissue Activity -Warm Exposure [ Time Frame: 5-6 hrs ]Brown adipose tissue activity in warm temperatures will be measured using the radioactive tracer 11C-acetate
- Brown Adipose Tissue Activity - ColdExposure [ Time Frame: 5-6 hrs ]Brown adipose tissue activity after cold exposure will be measured using the radioactive tracer 11C-acetate
- Resting energy expenditure - before cold exposure [ Time Frame: 5-6 hrs. ]Resting energy expenditure is the calories burned when a person is at rest.
- Resting energy expenditure - after cold exposure [ Time Frame: 5-6 hrs ]Resting energy expenditure is the calories burned when a person is at rest.
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): NCT02927392
|Contact: Tracy Swibas, M.S.||(303) email@example.com|
|Contact: Edward Melanson, Ph.D.||(303) firstname.lastname@example.org|
|United States, Colorado|
|University of Colorado Anschutz Medical Campus||Recruiting|
|Aurora, Colorado, United States, 80045|
|Principal Investigator:||Edward Melanson, Ph.D.||University of Colorado, Denver|