Brown Adipose Tissue Activity in Pre- and Postmenopausal Women

What Was Tested

In this not phased trial, researchers set out to test Leuprolide.

The physiological relevance of brown adipose tissue (BAT) in humans is largely unknown.

It had two arms (groups): Pre-menopausal women (experimental) and Post-menopausal women (no intervention).

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. the researchers will also explore whether suppression of ovarian hormones in pre-menopausal women (using leuprolide acetate) impairs BAT activity.

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.

The registry classes the interventions as drug.

More on the Plan

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.

Who Took Part

69 actual participants took part.

It was open to women only aged from 18 years up to 99 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: 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.

The full record lists 2 inclusion and 4 exclusion criteria; among the exclusions: hormonal contraceptive use (past 6 mo.); pregnant, lactating or intention to become pregnant during the period of study; history or current use of hormonal replacement therapy (hrt).

How the Study Was Run

Design: non-randomized, parallel-group and open-label.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Nothing was hidden in this open-label Leuprolide study: the participants and staff both knew the treatment.

It started in 2017-03-16 with completion listed for 2023-05-02.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: Brown Adipose Tissue Volume (time frame: 5-6 hrs). Brown Adipose Tissue Activity -Warm Exposure (time frame: 5-6 hrs). Brown Adipose Tissue Activity - ColdExposure (time frame: 5-6 hrs).

It also tracked 2 secondary outcomes, for example Resting Energy Expenditure - Before Cold Exposure and Resting Energy Expenditure - After Cold Exposure.

What This Means in Plain Language

Put simply, this is a not phased, non-randomized trial of Leuprolide in 69 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Leuprolide compound page, all human trials.