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Trial · Interventional

CompletedNot applicableResults postedRegistry data

Brown Adipose Tissue Activity in Pre- and Postmenopausal Women

NCTNCT02927392 (opens ClinicalTrials.gov in a new tab)Other id16-1479Other id1R01DK112260-01
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Not applicable
Enrollment
69 participants (actual)
Sponsor
University of Colorado, Denver · Other
Design
Not randomized · Open label (no masking)
Countries
1 country

United States

Start
16 Mar 2017
Primary completion
2 May 2023
Completion
2 May 2023
First posted
7 Oct 2016 (estimated)
Last update posted
13 Jun 2024
Conditions
Menopause · Obesity

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2018202020222024
  1. N/A

    Brown Adipose Tissue Activity in Pre- and Postmenopausal Women

    NCT02927392

    16 Mar 2017 to 2 May 2023

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Leuprolide acetateDrug

Arms2

  • 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.

  • 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.

Primary outcomes3

Outcomes the sponsor listed as primary.

  1. Brown Adipose Tissue Volume

    Time frame · 5-6 hrs

    Registry description

    Brown adipose tissue volume will be measured using the radioactive tracer 18Fluro-deoxyglucose.

  2. Brown Adipose Tissue Activity -Warm Exposure

    Time frame · 5-6 hrs

    Registry description

    Brown adipose tissue activity in warm temperatures will be measured using the radioactive tracer 11C-acetate

  3. Brown Adipose Tissue Activity - ColdExposure

    Time frame · 5-6 hrs

    Registry description

    Brown adipose tissue activity after cold exposure will be measured using the radioactive tracer 11C-acetate

Secondary outcomes(2)

  1. Resting Energy Expenditure - Before Cold Exposure

    Time frame · 5-6 hrs.

    Registry description

    Resting energy expenditure is the calories burned when a person is at rest.

  2. Resting Energy Expenditure - After Cold Exposure

    Time frame · 5-6 hrs

    Registry description

    Resting energy expenditure is the calories burned when a person is at rest.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 5-6 hrs

Brown Adipose Tissue Volume

GroupValue (mL)Spread
Pre-menopausal Women53.142.5
Post-menopausal Women20.629.7
Primary outcomeMean· 5-6 hrs

Brown Adipose Tissue Activity -Warm Exposure

GroupValue (disintegration per min (dpm))Spread
Pre-menopausal Women.5570.309
Post-menopausal Women.631.283
Primary outcomeMean· 5-6 hrs

Brown Adipose Tissue Activity - ColdExposure

GroupValue (disintegration per minute (dpm))Spread
Pre-menopausal Women1.277.851
Post-menopausal Women.906.544
Secondary and other outcome results(2)
Secondary outcomeMean· 5-6 hrs.

Resting Energy Expenditure - Before Cold Exposure

GroupValue (kcal/day)Spread
Pre-menopausal Women1334205
Post-menopausal Women1223189
Secondary outcomeMean· 5-6 hrs

Resting Energy Expenditure - After Cold Exposure

GroupValue (kcal/h)Spread
Pre-menopausal Women93.625.3
Post-menopausal Women85.019.3

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Pre-menopausal WomenTo 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. 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).0 / 280 / 280 / 28
Post-menopausal WomenTo 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.0 / 250 / 250 / 25

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years up to 99 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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.

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