N/A
N=47
Females, Aging, Metabolism, and Exercise
Obesity
Bottom Line
View on ClinicalTrials.gov: NCT01712230 ↗Enrolled (actual)
47
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcome: Primary: Change in Physical Activity Energy Expenditure (PAEE) — 74.5; -10.2; 61.0 kcal/day
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- GnRH agonist (Drug); Supervised cardiovascular exercise (Behavioral); Placebo (Drug)
- Age
- Adult · 40+ yrs
- Sex
- Female
- Sponsor
- University of Colorado, Denver
- Primary completion
- Oct 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Physical Activity Energy Expenditure (PAEE) |
74.5; -10.2; 61.0 | — |
| SECONDARY Total Fat Mass |
0.73; 1.66; 0.89 | — |
| SECONDARY Total Fat Free Mass |
0.1; -0.69; -0.66 | — |
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.
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 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
Data sourced from ClinicalTrials.gov (NCT01712230). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.