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Trial · Interventional

CompletedNot applicableResults postedRegistry data

Females, Aging, Metabolism, and Exercise

Short name FAME

NCTNCT01712230 (opens ClinicalTrials.gov in a new tab)Other id12-1157Other idP50HD073063

Overview

Status
Completed
Phase
Not applicable
Enrollment
47 participants (actual)
Sponsor
University of Colorado, Denver · Other
Design
Randomized · Triple masking
Countries
1 country

United States

Start
Oct 2012
Primary completion
Oct 2017
Completion
Oct 2017
First posted
23 Oct 2012 (estimated)
Last update posted
22 Nov 2019
Conditions
Obesity

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2012201320142015201620172018
  1. N/A

    FAME

    NCT01712230

    Oct 2012 to Oct 2017

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • GnRH agonistDrug
  • Supervised cardiovascular exerciseBehavioral
  • PlaceboDrug

Arms3

  • Placebo comparator

    Placebo

    Monthly placebo injections for 6 months

  • Active comparator

    GnRH agonist

    Monthly GnRH agonist injections for 6 months

  • Active comparator

    GnRH agonist + exercise

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

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in Physical Activity Energy Expenditure (PAEE)

    Time frame · Change from baseline to 6 months

    Registry 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).

Secondary outcomes(2)
  1. Total Fat Mass

    Time frame · Change over 6 months

    Registry description

    Total Fat mass as measured by DXA

  2. Total Fat Free Mass

    Time frame · Change over 6 months

    Registry description

    Total Fat Free Mass as measured by DXA

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Change from baseline to 6 months

Change in Physical Activity Energy Expenditure (PAEE)

GroupValue (kcal/day)Spread
Placebo74.577.9
GnRH Agonist-10.263.6
GnRH Agonist + Exercise61.066.4
Secondary and other outcome results(2)
Secondary outcomeMean· Change over 6 months

Total Fat Mass

GroupValue (kg)Spread
Placebo0.730.68
GnRH Agonist1.660.41
GnRH Agonist + Exercise0.890.60
Secondary outcomeMean· Change over 6 months

Total Fat Free Mass

GroupValue (kg)Spread
Placebo0.10.34
GnRH Agonist-0.690.34
GnRH Agonist + Exercise-0.660.59

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
PlaceboMonthly placebo injections for 6 months Placebo: Placebo0 / 100 / 103 / 10
GnRH AgonistMonthly GnRH agonist injections for 6 months GnRH agonist: Drug: leuprolide acetate Other Names: Lupron 3.75 mg for depot suspension delivered by monthly intramuscular injection for 6 months0 / 140 / 144 / 14
GnRH Agonist + ExerciseMonthly GnRH agonist injections for 6 months plus supervised cardiovascular exercise intervention GnRH agonist: Drug: leuprolide acetate Other Names: Lupron 3.75 mg for depot suspension delivered by monthly intramuscular injection for 6 months Supervised cardiovascular exercise: Supervised exercise, 4 days per week for 45 to 60 minutes per session for 6 months0 / 180 / 184 / 18

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedGavin 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. PMID 33150745

Eligibility

Who could join, as posted.

Sex
Female
Age
from 40 Years up to 60 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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

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