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Completed

NCT Number: NCT01846728

Effects of Estrogen Deficiency on Energy Expenditure

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.

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Key information

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

About this study

The purpose of this pilot study is to investigate the role of the female sex hormone estrogen, on metabolism, thermoregulation and energy expenditure. Weight and fat gain increase after the menopause, but reasons for this are not clear. Loss of estrogen may cause changes in how women regulate metabolism and thermoregulation, possibly leading to weight gain. Specifically, this study will determine how loss of estrogen affects facultative thermogenesis. Loosely defined, facultative thermogenesis represents heat production that is turned on when needed. For example, when body core temperature falls below a certain threshold, a shivering response is invoked in skeletal muscle to increase heat production and, thus, energy expenditure. However, exposure over several hours to mild cold temperatures that do not trigger shivering (16-20⁰ C) also induces an increase in energy expenditure (cold-induced non-shivering thermogenesis). Although several different tissues may contribute to this response, the recent identification of functional brown adipose tissue (BAT) in humans has promoted an interest in how BAT is activated in humans and its potential role in regulating energy balance and body weight. The investigators will measure BAT activity using PET/CT scans pre and post three months of estrogen suppression.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Estrogen suppression

Drug

Estrogen production will be suppressed for 3 months by administering a drug, lupron, that suppresses ovarian function

Other names: Lupron

Primary outcomes

  1. Brown Adipose Tissue Activity

    Time frame: Baseline and after 3 months of suppression

    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

  1. Cold Induced Thermogenesis

    Time frame: Baseline and after 3 months of suppression

    The increase in energy expenditure above resting during cold exposure

  2. Fat Mass

    Time frame: Baseline and after 3 months of suppression

    Amount of body fat (in kg)

  3. Fat Free Mass

    Time frame: Baseline and after 3 mo of suppression

    Fat free mass measured by DXA

  4. Resting Energy Expenditure

    Time frame: after 3 months of suppression

    Energy expenditure measured in the resting state

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

Ovarian Function and Facultative Thermogenesis

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
May 3, 2013
Registry last updated
Nov 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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