Clinical trial

The Impact of Estrogen Status on the Biological Function of Brown Adipose Tissue in Women Measured Using Quantitative PET/CT

Name
16-1479
Description
The physiological relevance of brown adipose tissue (BAT) in humans is largely unknown. The investigators have shown that suppressing ovarian function in premenopausal women reduces resting energy expenditure (REE), and this is prevented by adding back estradiol (E2). The investigators preliminary data suggest that this may be due, in part, to reduced brown adipose tissue (BAT) activity. The overarching hypothesis is that BAT activity in humans is modulated by E2. To determine if natural declines in endogenous E2 contribute to changes in BAT activity, we will compare BAT activity in pre-and post-menopausal women. The investigators will also explore whether suppression of ovarian hormones in pre-menopausal women impairs BAT activity. BAT activity will be quantified using dynamic positron emission topography/computed tomography (PET/CT) imaging combined with 11C-acetate tracers. We will assess the thermogenic response of BAT by measuring cold-induced changes in REE, shivering, and skin and core temperature.
Trial arms
Trial start
2017-01-01
Estimated PCD
2023-05-02
Trial end
2023-05-02
Status
Completed
Treatment
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).
Arms:
Pre-menopausal women
Other names:
Lupron
Size
72
Primary endpoint
Brown Adipose Tissue Volume
5-6 hrs
Brown Adipose Tissue Activity -Warm Exposure
5-6 hrs
Brown Adipose Tissue Activity - ColdExposure
5-6 hrs
Eligibility criteria
Inclusion Criteria: * Premenopausal volunteers will be healthy, eumenorrheic women, aged 18-45 yrs. Eumenorrheic status will be verified by regular menses (no missed cycles in previous year; cycle length 25-35 d). * Postmenopausal volunteers will be healthy women who have no menses for at least 12 months Exclusion Criteria: - Body mass index (BMI) \> 35 kg/m2 Additional exclusion criteria for premenopausal women * Hormonal contraceptive use (past 6 mo.) * Pregnant, lactating or intention to become pregnant during the period of study Additional exclusion criteria for postmenopausal women * History or current use of hormonal replacement therapy (HRT) * Women who have undergone surgical menopause.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 72, 'type': 'ESTIMATED'}}
Updated at
2023-12-04

1 organization

1 product

2 indications

Product
Leuprolide
Indication
Menopause
Indication
Obesity