ObesityFAMENCT01712230
Females, Aging, Metabolism, and Exercise
A study testing GnRH agonist and Supervised cardiovascular exercise in people with Obesity, run by University of Colorado, Denver at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- GnRH agonist and Supervised cardiovascular exercise
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Oct 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado - Anschutz Medical Campus
Aurora, Colorado, 80045
About this study
Official title: 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.
Read the 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.
- Conditions
- Obesity
- Being tested
- GnRH agonist, Supervised cardiovascular exercise, Placebo
- Keywords
- hormone therapy, obesity, menopause, disease /disorder proneness /risk, insulin sensitivity /resistance, metabolic syndrome, women's health
- Medical subject headings
- Obesity, Disease Susceptibility, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GnRH agonistDrug
Also called Leuprolide Acetate 3.75mg
Drug: leuprolide acetate
Other Names:
Lupron 3.75 mg for depot suspension delivered by monthly intramuscular injection for 6 months
Supervised cardiovascular exerciseBehavioural
Supervised exercise, 4 days per week for 45 to 60 minutes per session for 6 months
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Monthly placebo injections for 6 months Receives: Drug: Placebo |
| GnRH agonist | Active comparator | Monthly GnRH agonist injections for 6 months Receives: Drug: GnRH agonist |
| GnRH agonist + exercise | Active comparator | Monthly GnRH agonist injections for 6 months plus supervised cardiovascular exercise intervention Receives: Drug: GnRH agonist; Behavioral: Supervised cardiovascular exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Physical Activity Energy Expenditure (PAEE)
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).
Measured: Change from baseline to 6 months
Secondary outcomes (2)
Total Fat Mass
Total Fat mass as measured by DXA
Measured: Change over 6 months
Total Fat Free Mass
Total Fat Free Mass as measured by DXA
Measured: Change over 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionOct 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Wendy Kohrt, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01712230
- Sponsor's protocol ID
- 12-1157
- Other IDs
- P50HD073063
- Acronym
- FAME
- Status last verified
- Nov 2019
- First submitted
- 19 Oct 2012
- Last updated
- 22 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Gavin KM, Melanson EL, Hildreth KL, Gibbons E, Bessesen DH, Kohrt WM. A Randomized Controlled Trial of Ovarian Suppression in Premenopausal Women: No Change in Free-Living Energy Expenditure. Obesity (Silver Spring). 2020 Nov;28(11):2125-2133. doi: 10.1002/oby.22978.
PubMed 33150745
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioenergetic and Metabolic Consequences of the Loss of Ovarian Function in Women
- ClinicalTrials.gov ID
- NCT01712230
- Acronym / sponsor ID
- FAME / 12-1157
- Conditions
- Obesity
- Keywords
- hormone therapy, obesity, menopause, disease /disorder proneness /risk, insulin sensitivity /resistance, metabolic syndrome, women's health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Oct 2012
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 23 Oct 2012 (estimated)
- Results
- Posted 22 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboMonthly placebo injections for 6 months |
| GnRH agonist | Active comparator | Drug: GnRH agonistMonthly GnRH agonist injections for 6 months |
| GnRH agonist + exercise | Active comparator | Drug: GnRH agonist, Behavioral: Supervised cardiovascular exerciseMonthly GnRH agonist injections for 6 months plus supervised cardiovascular exercise intervention |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GnRH agonistAlso: Leuprolide Acetate 3.75mgDrug: leuprolide acetate Other Names: Lupron 3.75 mg for depot suspension delivered by monthly intramuscular injection for 6 months | Drug | GnRH agonist, GnRH agonist + exercise |
| Supervised cardiovascular exerciseSupervised exercise, 4 days per week for 45 to 60 minutes per session for 6 months | Behavioural | GnRH agonist + exercise |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
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).
2 secondary outcomes
Total Fat Mass
Time frame: Change over 6 months
Total Fat Free Mass
Time frame: Change over 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33150745Gavin KM, Melanson EL, Hildreth KL, Gibbons E, Bessesen DH, Kohrt WM. A Randomized Controlled Trial of Ovarian Suppression in Premenopausal Women: No Change in Free-Living Energy Expenditure. Obesity (Silver Spring). 2020 Nov;28(11):2125-2133. doi: 10.1002/oby.22978.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wendy Kohrt, PhD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GnRH agonist and Supervised cardiovascular exercise in people with Obesity, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Physical Activity Energy Expenditure (PAEE) (time frame: Change from baseline to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01712230, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2019.