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Females, Aging, Metabolism, and Exercise (FAME)

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
GnRH agonist
Supervised cardiovascular exercise
Placebo
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Obesity focused on measuring hormone therapy, obesity, menopause, disease /disorder proneness /risk, insulin sensitivity /resistance, metabolic syndrome, women's health

Eligibility Criteria

40 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. Healthy women aged 40 to 60 years
  2. Are still experiencing regular menstrual cycles.
  3. They must be willing to be randomized to placebo or GnRHAG therapy for 24 weeks
  4. Be physically able to be randomized to participate in a programmed exercise training program.

The investigators will consent up to 132 subjects with the aim of enrolling 22 in each of the 3 groups (placebo, GnRHAG, or GnRHAG+Exercise).

Exclusion Criteria:

  • irregular menstrual cycles defined as 2 or more missed cycles in the previous year
  • serum FSH >25 mIU/mL measured during the first 5 days of the menstrual cycle
  • on hormonal contraceptive or menopausal therapy
  • positive pregnancy test
  • intention to become pregnant or start hormonal contraceptive therapy during the period of study
  • lactation
  • known hypersensitivity to GnRH or leuprolide acetate
  • score >16 on the CESD((Center for Epidemiologic Studies Depression Scale )
  • severe osteopenia or osteoporosis (i.e., proximal femur or lumbar spine t scores < -2.0)
  • abnormal vaginal bleeding
  • thyroid dysfunction, defined as an ultrasensitive TSH <0.5 or >5.0 mU/L; volunteers with abnormal TSH values will be re-considered for participation in the study after follow-up evaluation by the PCP with initiation or adjustment of thyroid hormone replacement
  • uncontrolled hypertension defined as resting systolic BP >150 mmHg or diastolic BP>90 mmHg; participants who do not meet these criteria at first screening will be re-evaluated, including after follow-up evaluation by the PCP with initiation or adjustment of anti-hypertensive medications
  • cardiovascular disease; subjective or objective indicators of ischemic heart disease (e.g., angina, ST segment depression) or serious arrhythmias at rest or during the graded exercise test (GXT) without follow-up evaluation; follow-up evaluation must include diagnostic testing (e.g., thallium stress test) with interpretation by a cardiologist
  • orthopedic or other problems that would interfere with participation in the exercise program
  • exercising at least 30 minutes per day at a moderate to vigorous intensity most days of the week (defined as >4 d/wk) over the past 6 months
  • BMI <40 kg/m2

Sites / Locations

  • University of Colorado - Anschutz Medical Campus

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

Placebo

GnRH agonist

GnRH agonist + exercise

Arm Description

Monthly placebo injections for 6 months

Monthly GnRH agonist injections for 6 months

Monthly GnRH agonist injections for 6 months plus supervised cardiovascular exercise intervention

Outcomes

Primary Outcome Measures

Change in Physical Activity Energy Expenditure (PAEE)
PAEE will be calculated as: TEE - REE - TEF, where TEE is total energy expenditure (measured by doubly-labeled water), REE is resting energy expenditure (measured by indirect calorimetry), and TEF is the thermic effect of feeding (estimated using a constant).

Secondary Outcome Measures

Total Fat Mass
Total Fat mass as measured by DXA
Total Fat Free Mass
Total Fat Free Mass as measured by DXA

Full Information

First Posted
October 19, 2012
Last Updated
November 20, 2019
Sponsor
University of Colorado, Denver
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT01712230
Brief Title
Females, Aging, Metabolism, and Exercise
Acronym
FAME
Official Title
Bioenergetic and Metabolic Consequences of the Loss of Ovarian Function in Women
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
October 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is designed to determine whether a reduction in hormones (such as occurs during menopause) causes a decrease in calories burned during physical activity. This study will also determine whether a reduction in hormones decreases calories burned while sleeping, resting, and eating and whether an exercise intervention can prevent this.
Detailed Description
Participants will be women who are nearing menopause based on age (42-52 y) but have normal menstrual cycles. Participants will be randomized to receive monthly injections of placebo or a study drug that reduces sex hormones (GnRH agonist) for 24 weeks. Women who receive GnRH agonist will be further randomized to no exercise or a supervised exercise program. Thus, the 3 treatment groups are: placebo, GnRH agonist, GnRH agonist+exercise. The investigators will measure changes in calories burned during physical activity, sleep, rest, and after a meal after 3 and 6 months of hormone suppression using doubly-labeled water and room calorimetry. Other measures include food intake estimated from food records; body composition measured by dual-energy x-ray absorptiometry (DXA); glucose and insulin responses to an oral glucose tolerance test; and markers of inflammation in the blood.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
hormone therapy, obesity, menopause, disease /disorder proneness /risk, insulin sensitivity /resistance, metabolic syndrome, women's health

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Monthly placebo injections for 6 months
Arm Title
GnRH agonist
Arm Type
Active Comparator
Arm Description
Monthly GnRH agonist injections for 6 months
Arm Title
GnRH agonist + exercise
Arm Type
Active Comparator
Arm Description
Monthly GnRH agonist injections for 6 months plus supervised cardiovascular exercise intervention
Intervention Type
Drug
Intervention Name(s)
GnRH agonist
Other Intervention Name(s)
Leuprolide Acetate 3.75mg
Intervention Description
Drug: leuprolide acetate Other Names: Lupron 3.75 mg for depot suspension delivered by monthly intramuscular injection for 6 months
Intervention Type
Behavioral
Intervention Name(s)
Supervised cardiovascular exercise
Intervention Description
Supervised exercise, 4 days per week for 45 to 60 minutes per session for 6 months
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Change in Physical Activity Energy Expenditure (PAEE)
Description
PAEE will be calculated as: TEE - REE - TEF, where TEE is total energy expenditure (measured by doubly-labeled water), REE is resting energy expenditure (measured by indirect calorimetry), and TEF is the thermic effect of feeding (estimated using a constant).
Time Frame
Change from baseline to 6 months
Secondary Outcome Measure Information:
Title
Total Fat Mass
Description
Total Fat mass as measured by DXA
Time Frame
Change over 6 months
Title
Total Fat Free Mass
Description
Total Fat Free Mass as measured by DXA
Time Frame
Change over 6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy women aged 40 to 60 years Are still experiencing regular menstrual cycles. They must be willing to be randomized to placebo or GnRHAG therapy for 24 weeks Be physically able to be randomized to participate in a programmed exercise training program. The investigators will consent up to 132 subjects with the aim of enrolling 22 in each of the 3 groups (placebo, GnRHAG, or GnRHAG+Exercise). Exclusion Criteria: irregular menstrual cycles defined as 2 or more missed cycles in the previous year serum FSH >25 mIU/mL measured during the first 5 days of the menstrual cycle on hormonal contraceptive or menopausal therapy positive pregnancy test intention to become pregnant or start hormonal contraceptive therapy during the period of study lactation known hypersensitivity to GnRH or leuprolide acetate score >16 on the CESD((Center for Epidemiologic Studies Depression Scale ) severe osteopenia or osteoporosis (i.e., proximal femur or lumbar spine t scores < -2.0) abnormal vaginal bleeding thyroid dysfunction, defined as an ultrasensitive TSH <0.5 or >5.0 mU/L; volunteers with abnormal TSH values will be re-considered for participation in the study after follow-up evaluation by the PCP with initiation or adjustment of thyroid hormone replacement uncontrolled hypertension defined as resting systolic BP >150 mmHg or diastolic BP>90 mmHg; participants who do not meet these criteria at first screening will be re-evaluated, including after follow-up evaluation by the PCP with initiation or adjustment of anti-hypertensive medications cardiovascular disease; subjective or objective indicators of ischemic heart disease (e.g., angina, ST segment depression) or serious arrhythmias at rest or during the graded exercise test (GXT) without follow-up evaluation; follow-up evaluation must include diagnostic testing (e.g., thallium stress test) with interpretation by a cardiologist orthopedic or other problems that would interfere with participation in the exercise program exercising at least 30 minutes per day at a moderate to vigorous intensity most days of the week (defined as >4 d/wk) over the past 6 months BMI <40 kg/m2
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wendy Kohrt, PhD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado - Anschutz Medical Campus
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33150745
Citation
Gavin KM, Melanson EL, Hildreth KL, Gibbons E, Bessesen DH, Kohrt WM. A Randomized Controlled Trial of Ovarian Suppression in Premenopausal Women: No Change in Free-Living Energy Expenditure. Obesity (Silver Spring). 2020 Nov;28(11):2125-2133. doi: 10.1002/oby.22978.
Results Reference
derived

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Females, Aging, Metabolism, and Exercise

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