N/A
N=69
Brown Adipose Tissue Activity in Pre- and Postmenopausal Women
Menopause · Obesity
Bottom Line
View on ClinicalTrials.gov: NCT02927392 ↗Enrolled (actual)
69
Serious AEs
0.0%
Results posted
Jun 2024
Primary outcome: Primary: Brown Adipose Tissue Volume — 53.1; 20.6 mL
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Leuprolide acetate (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Colorado, Denver
- Primary completion
- May 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Brown Adipose Tissue Volume |
53.1; 20.6 | — |
| PRIMARY Brown Adipose Tissue Activity -Warm Exposure |
.557; .631 | <0.0001 sig |
| PRIMARY Brown Adipose Tissue Activity - ColdExposure |
1.277; .906 | — |
| SECONDARY Resting Energy Expenditure - Before Cold Exposure |
1334; 1223 | — |
| SECONDARY Resting Energy Expenditure - After Cold Exposure |
93.6; 85.0 | — |
Summary
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.
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.
Data sourced from ClinicalTrials.gov (NCT02927392). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.