Effects of Estrogen Deficiency on Energy Expenditure

NCT01846728 | Completed Results DMC

• 2 other identifiers: 13-0149P50HD073063
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Brown Adipose Tissue Activity

  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).

  Baseline and after 3 months of suppression

Secondary Outcomes (4)

• Cold Induced Thermogenesis

  Baseline and after 3 months of suppression

• Fat Mass

  Baseline and after 3 months of suppression

• Fat Free Mass

  Baseline and after 3 mo of suppression

• Resting Energy Expenditure

  after 3 months of suppression

Study Arms (1)

Estrogen suppression

EXPERIMENTAL

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

Drug: Estrogen suppression

Interventions

Estrogen suppression DRUG

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

Also known as: Lupron

Estrogen suppression

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Body mass index \< 30 kg/m2
• Normal menstrual cycles
• Premenopausal

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

Leuprolide

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Limitations and Caveats

This was a pilot study to generate preliminary data for an NIH grant application. there was insufficient power to detect significant differences.

Results Point of Contact

• Title: Edward Melanson, PhD
• Organization: University of Colorado Anschutz Medical Campus

ed.melanson@cuanschutz.edu

303-724-0935

Study Officials

• Edward Melanson, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2013
• First Posted: May 3, 2013
• Study Start: April 1, 2013
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2016
• Last Updated: November 18, 2019
• Results First Posted: November 18, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)