Effects of Estrogen Deficiency on Energy Expenditure

NCT ID: NCT01846728

Last Updated: 2019-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2016-10-31

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.

Detailed Description

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.

Conditions

Obesity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Estrogen suppression

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

Group Type: EXPERIMENTAL

Estrogen suppression

Intervention Type: DRUG

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

Interventions

Estrogen suppression

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

Intervention Type: DRUG

Other Intervention Names

Lupron

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

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

NIH

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Edward Melanson, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

Countries

United States

Other Identifiers

P50HD073063

Identifier Type: NIH

Identifier Source: secondary_id

View Link

13-0149

Identifier Type: -

Identifier Source: org_study_id