Females, Aging, Metabolism, and Exercise (FAME)
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Purpose
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 | Intervention |
|---|---|
|
Obesity |
Drug: GnRH agonist Behavioral: Supervised cardiovascular exercise |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Basic Science |
| Official Title: | Bioenergetic and Metabolic Consequences of the Loss of Ovarian Function in Women |
- 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).
- 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 ]
| Estimated Enrollment: | 132 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | October 2017 |
| Estimated Primary Completion Date: | October 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Placebo
Monthly placebo injections for 6 months
|
|
|
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 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
|
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.
Eligibility| Ages Eligible for Study: | 42 Years to 52 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria: Volunteers will be healthy women aged 42 to 52 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 >18 on the BDI-II (Beck Depression Inventory)
- 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 >35 kg/m2
Contacts and Locations| Contact: Annie Stavros, BS | 720-848-6399 | anne.stavros@ucdenver.edu |
| Contact: Ellie Gibbons, BA | 720-848-6408 | ellie.gibbons@ucdenver.edu |
| United States, Colorado | |
| University of Colorado - Anschutz Medical Campus | Recruiting |
| Aurora, Colorado, United States, 80045 | |
| Principal Investigator: Wendy M Kohrt, PhD | |
| Sub-Investigator: Rachael VanPelt, PhD | |
| Sub-Investigator: Edward Melanson, PhD | |
| Sub-Investigator: Karen Villalon, MD | |
| Sub-Investigator: Daniel Bessesen, MD | |
| Sub-Investigator: David Weitzenkamp, PhD | |
More Information
No publications provided
| Responsible Party: | University of Colorado, Denver |
| ClinicalTrials.gov Identifier: | NCT01712230 History of Changes |
| Other Study ID Numbers: | 12-1157, P50HD073063 |
| Study First Received: | October 19, 2012 |
| Last Updated: | October 29, 2012 |
| Health Authority: | United States: Federal Government |
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:
|
Obesity Overnutrition Nutrition Disorders Overweight Body Weight Signs and Symptoms Deslorelin Triptorelin Leuprolide Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Luteolytic Agents Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents Physiological Effects of Drugs Therapeutic Uses Antineoplastic Agents, Hormonal Antineoplastic Agents Fertility Agents, Female Fertility Agents |
ClinicalTrials.gov processed this record on May 19, 2013