Bioenergetic and Metabolic Consequences of the Loss of Ovarian Function in Women
Overview
- Phase
- Not Applicable
- Intervention
- Placebo
- Conditions
- Obesity
- Sponsor
- University of Colorado, Denver
- Enrollment
- 47
- Locations
- 1
- Primary Endpoint
- Change in Physical Activity Energy Expenditure (PAEE)
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
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
Arms & Interventions
Placebo
Monthly placebo injections for 6 months
Intervention: Placebo
GnRH agonist
Monthly GnRH agonist injections for 6 months
Intervention: GnRH agonist
GnRH agonist + exercise
Monthly GnRH agonist injections for 6 months plus supervised cardiovascular exercise intervention
Intervention: GnRH agonist
GnRH agonist + exercise
Monthly GnRH agonist injections for 6 months plus supervised cardiovascular exercise intervention
Intervention: Supervised cardiovascular exercise
Outcomes
Primary Outcomes
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 Outcomes
- Total Fat Mass(Change over 6 months)
- Total Fat Free Mass(Change over 6 months)