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Effects of Estrogen Deficiency on Energy Expenditure

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ClinicalTrials.gov Identifier: NCT01846728
Recruitment Status : Completed
First Posted : May 3, 2013
Last Update Posted : October 5, 2016
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
University of Colorado, Denver

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Obesity Drug: Estrogen suppression Not Applicable

Detailed Description:
The purpose of this 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Ovarian Function and Facultative Thermogenesis
Study Start Date : April 2013
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Estrogen suppression
Estrogen production will be suppressed using Lupron, a drug that blocks normal production of ovarian hormones
Drug: Estrogen suppression
Estrogen production will be suppressed for 3 months by administering a drug, lupron, that suppresses ovarian function
Other Name: Lupron




Primary Outcome Measures :
  1. Brown adipose tissue activity [ Time Frame: 3 months ]
    Brown adipose tissue activity will be measured using PET/CT before and after 3 months of estrogen suppression



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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01846728


Locations
United States, Colorado
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: Edward Melanson, PhD University of Colorado, Denver

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01846728     History of Changes
Other Study ID Numbers: 13-0149
P50HD073063 ( U.S. NIH Grant/Contract )
First Posted: May 3, 2013    Key Record Dates
Last Update Posted: October 5, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
Estrogens
Leuprolide
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents