CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 69 enrolled
Drug / intervention
Leuprolide acetatedrug
Likely dose
Leuprolide acetate 3.75 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02927392
NCT02927392N/ACompleted

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

University of Colorado, Denver·interventional·Posted Oct 7, 2016·Updated Jun 13, 2024

In Brief

A clinical study evaluating Leuprolide acetate for Menopause and Obesity. Completed, enrolled 69 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMenopause, Obesity
CountriesUnited States

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedOct 7, 2016
Enrollment StartMar 16, 2017
Primary CompletionMay 2, 2023
TodayJul 2, 2026
Enrollment to primary: 6.1 yearsPosted 9.7 years ago

Interventions

Leuprolide acetatedrug

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).