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Females, Aging, Metabolism, and Exercise (FAME)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01712230
Recruitment Status : Completed
First Posted : October 23, 2012
Results First Posted : November 22, 2019
Last Update Posted : November 22, 2019
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
University of Colorado, Denver

Study Description
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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.

Condition or disease Intervention/treatment Phase
Obesity Drug: GnRH agonist Behavioral: Supervised cardiovascular exercise Drug: Placebo Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Bioenergetic and Metabolic Consequences of the Loss of Ovarian Function in Women
Study Start Date : October 2012
Actual Primary Completion Date : October 2017
Actual Study Completion Date : October 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo
Monthly placebo injections for 6 months
 Drug: Placebo
Placebo
Active Comparator: GnRH agonist
Monthly GnRH agonist injections for 6 months
 Drug: GnRH agonist

Drug: leuprolide acetate

Other Names:

Lupron 3.75 mg for depot suspension delivered by monthly intramuscular injection for 6 months

Other Name: Leuprolide Acetate 3.75mg
Active Comparator: GnRH agonist + exercise
Monthly GnRH agonist injections for 6 months plus supervised cardiovascular exercise intervention
 Drug: GnRH agonist

Drug: leuprolide acetate

Other Names:

Lupron 3.75 mg for depot suspension delivered by monthly intramuscular injection for 6 months

Other Name: Leuprolide Acetate 3.75mg

Behavioral: Supervised cardiovascular exercise
Supervised exercise, 4 days per week for 45 to 60 minutes per session for 6 months


Outcome Measures
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Primary Outcome Measures :
  1. Change in Physical Activity Energy Expenditure (PAEE) [ Time Frame: Change from baseline to 6 months ]
    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 :
  1. Total Fat Mass [ Time Frame: Change over 6 months ]
    Total Fat mass as measured by DXA

  2. Total Fat Free Mass [ Time Frame: Change over 6 months ]
    Total Fat Free Mass as measured by DXA


Eligibility Criteria
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Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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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): NCT01712230


Locations
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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
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Principal Investigator: Wendy Kohrt, PhD University of Colorado, Denver
  Study Documents (Full-Text)

Documents provided by University of Colorado, Denver:
Study Protocol and Statistical Analysis Plan  [PDF] October 15, 2019

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01712230    
Other Study ID Numbers: 12-1157
P50HD073063 ( U.S. NIH Grant/Contract )
First Posted: October 23, 2012    Key Record Dates
Results First Posted: November 22, 2019
Last Update Posted: November 22, 2019
Last Verified: November 2019
Keywords provided by University of Colorado, Denver:
hormone therapy
obesity
menopause
disease /disorder proneness /risk
 insulin sensitivity /resistance
metabolic syndrome
women's health
Additional relevant MeSH terms:
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Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Leuprolide
 Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents