Females, Aging, Metabolism, and Exercise (FAME)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University of Colorado, Denver
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01712230
First received: October 19, 2012
Last updated: June 26, 2014
Last verified: June 2014

October 19, 2012
June 26, 2014
October 2012
October 2017   (final data collection date for primary outcome measure)
Physical activity energy expenditure (PAEE) [ Time Frame: Change from baseline to 3 and 6 months ] [ Designated as safety issue: No ]
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 (measured by indirect calorimetry).
Same as current
Complete list of historical versions of study NCT01712230 on ClinicalTrials.gov Archive Site
Total energy expenditure, sleeping EE, thermic effect of feeding, body composition, energy intake [ Time Frame: Baseline, 3 months, 6 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Females, Aging, Metabolism, and Exercise
Bioenergetic and Metabolic Consequences of the Loss of Ovarian Function in Women

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Obesity
  • 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
  • Placebo Comparator: Placebo
    Monthly placebo injections for 6 months
  • Active Comparator: GnRH agonist
    Monthly GnRH agonist injections for 6 months
    Intervention: Drug: GnRH agonist
  • Active Comparator: GnRH agonist + exercise
    Monthly GnRH agonist injections for 6 months plus supervised exercise intervention
    Interventions:
    • Drug: GnRH agonist
    • Behavioral: Supervised cardiovascular exercise
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
132
October 2017
October 2017   (final data collection date for primary outcome measure)

Inclusion Criteria: Volunteers will be healthy women aged 40 to 60 years who are still experiencing regular menstrual cycles. They must be willing to be randomized to placebo or GnRHAG therapy for 24 weeks and physically able to be randomized to participate in a programmed exercise training program. We 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
Female
40 Years to 60 Years
Yes
Contact: Kim Harner, MS 720-848-6399 kimberly.harner@ucdenver.edu
Contact: Ellie Gibbons, BA 720-848-6408 ellie.gibbons@ucdenver.edu
United States
 
NCT01712230
12-1157, P50HD073063
No
University of Colorado, Denver
University of Colorado, Denver
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Not Provided
University of Colorado, Denver
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP