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Trial · Interventional

CompletedNot applicableResults postedRegistry data

Effects of Estrogen Deficiency on Energy Expenditure

NCTNCT01846728 (opens ClinicalTrials.gov in a new tab)Other id13-0149Other idP50HD073063
Open at ClinicalTrials.govAsk about this trial

Overview

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

United States

Start
Apr 2013
Primary completion
Oct 2015
Completion
Oct 2016
First posted
3 May 2013 (estimated)
Last update posted
18 Nov 2019
Conditions
Obesity

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20132014201520162017
  1. N/A

    Effects of Estrogen Deficiency on Energy Expenditure

    NCT01846728

    Apr 2013 to Oct 2016

Registry summary

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

Menopause is associated with weight gain, but the reasons why are not clear. In this study, the investigators will determine if reducing estrogen levels causes a decrease in the ability of the body to produce heat. If so, this would suggest this is one way that menopause may cause weight gain.

Interventions

  • Estrogen suppressionDrug

Arms1

  • Experimental

    Estrogen suppression

    Estrogen production will be suppressed using Lupron, a drug that blocks normal production of ovarian hormones

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Brown Adipose Tissue Activity

    Time frame · Baseline and after 3 months of suppression

    Registry description

    Brown adipose tissue activity will be measured using Positron Emission Tomography/computer tomography (PET/CT) before and after 3 months of estrogen suppression. Activity is quantified as the standard uptake value (SUV), It is a mathematically derived ratio that is a semiquantitative measure of the tracer uptake in a region of interest that normalizes the lesion activity to the injected activity and a measure of the volume of distribution (usually total body weight or lean body mass).

Secondary outcomes(4)

  1. Cold Induced Thermogenesis

    Time frame · Baseline and after 3 months of suppression

    Registry description

    The increase in energy expenditure above resting during cold exposure

  2. Fat Mass

    Time frame · Baseline and after 3 months of suppression

    Registry description

    Amount of body fat (in kg)

  3. Fat Free Mass

    Time frame · Baseline and after 3 mo of suppression

    Registry description

    Fat free mass measured by DXA

  4. Resting Energy Expenditure

    Time frame · after 3 months of suppression

    Registry description

    Energy expenditure measured in the resting state

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· Baseline and after 3 months of suppression

Brown Adipose Tissue Activity

GroupValue (Standard uptake value (SUV))Spread
Estrogen Suppression3.91.8
Secondary and other outcome results(4)
Secondary outcomeMean· Baseline and after 3 months of suppression

Cold Induced Thermogenesis

GroupValue (kcal)Spread
Estrogen Suppression350228
Secondary outcomeMean· Baseline and after 3 months of suppression

Fat Mass

GroupValue (kg)Spread
Estrogen Suppression24.28.9
Secondary outcomeMean· Baseline and after 3 mo of suppression

Fat Free Mass

GroupValue (kg)Spread
Estrogen Suppression40.38.4
Secondary outcomeMean· after 3 months of suppression

Resting Energy Expenditure

GroupValue (kcal)Spread
Estrogen Suppression1382218

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Estrogen SuppressionEstrogen production will be suppressed using Lupron, a drug that blocks normal production of ovarian hormones Estrogen suppression: Estrogen production will be suppressed for 3 months by administering a drug, lupron, that suppresses ovarian function0 / 60 / 62 / 6

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 20 Years up to 40 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Body mass index \< 30 kg/m2 * Normal menstrual cycles * Premenopausal Exclusion Criteria: * irregular menstrual cycles defined as 2 or more missed cycles in the previous year * on hormonal contraceptive or menopausal therapy * positive pregnancy test * intention to become pregnant or start hormonal contraceptive therapy during the period of study * lactation * severe osteopenia or osteoporosis (i.e., proximal femur or lumbar spine t scores \< -2.0) * abnormal vaginal bleeding * thyroid dysfunction * uncontrolled hypertension * exercising at least 30 minutes per day at a moderate to vigorous intensity \>1 d/wk) over the past 6 months

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