Hypogonadotropic HypogonadismLEAPNCT05808647
Low Energy Availability and Pituitary Function (LEAP Study)
A study of Hypogonadotropic Hypogonadism, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The purpose of this study is to learn more about reproductive hormones and if they change in response to 5-days eating an individualized, standardized diet at two levels: energy balance and low energy intake. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hypogonadotropic Hypogonadism
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2023to Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female
- Age 18-30
- Body mass index between 18.5-24.9 OR 30-45
- Have regular menstrual cycles between 18-40 days over the past 6 months
- Weight stable (not gained or lost 5kg) in the past 3 months
Who cannot join
- Using hormonal birth control currently or within the past three months
- Polycystic ovary syndrome (current or past diagnosis)
- Pregnant, lactating, planning to become pregnant in next 6 months
- Engaging in regular intentional aerobic exercise
- Significant medical issues (e.g.,cardiovascular disease or diabetes)
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
Trish Coordinator, MS, RD
About this study
Official title: A Randomized Cross-over Study of Low Energy Availability on Pituitary Function in Women
The purpose of this study is to learn more about reproductive hormones and if they change in response to 5-days eating an individualized, standardized diet at two levels: energy balance and low energy intake.
- Conditions
- Hypogonadotropic Hypogonadism
- Being tested
- 5-day controlled metabolic dietary intake
- Medical subject headings
- Hypogonadism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5-day controlled metabolic dietary intakeBehavioural
Over 5-days, all food will be provided from the metabolic kitchen and participants will be instructed to eat all of the food provided each day and only the food provided each day.
| Study group | Role | What they receive |
|---|---|---|
| Energy balanced metabolic diet (5-days) | Active comparator | 45 kcals/kg of fat free mass [FFM]/day; 28% fat, 15% protein, 57% carbohydrate Receives: Behavioral: 5-day controlled metabolic dietary intake |
| Low energy availability metabolic diet (5-days) | Experimental | 20 kcal/kg of FFM/day; 28% fat, 15% protein, 57% carbohydrate Receives: Behavioral: 5-day controlled metabolic dietary intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in stimulated pituitary function, as measured by Luteinizing hormone (LH) area under the curve (AUC) over two hours following pituitary stimulation with a physiologic bolus intravenous dose of gonadorelin acetate
Within-participant changes in response to both conditions will be measured, with lower LH AUC indicating a blunted pituitary response to stimulation.
Measured: Baseline, ~4-weeks, ~8-weeks (visits timed to to days 1-5 of the menstrual cycle)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2023
- Study startApr 2023 (estimated)
- Primary completionNov 2024 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypogonadotropic HypogonadismStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ann E Caldwell, PhD, Principal investigator, University of Colorado Anschutz School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05808647
- Sponsor's protocol ID
- 22-1811
- Acronym
- LEAP
- Status last verified
- Apr 2023
- First submitted
- 29 Mar 2023
- Last updated
- 11 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Cross-over Study of Low Energy Availability on Pituitary Function in Women
- ClinicalTrials.gov ID
- NCT05808647
- Acronym / sponsor ID
- LEAP / 22-1811
- Conditions
- Hypogonadotropic Hypogonadism
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Apr 2023 (estimated)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 11 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to learn more about reproductive hormones and if they change in response to 5-days eating an individualized, standardized diet at two levels: energy balance and low energy intake.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Energy balanced metabolic diet (5-days) | Active comparator | Behavioral: 5-day controlled metabolic dietary intake45 kcals/kg of fat free mass [FFM]/day; 28% fat, 15% protein, 57% carbohydrate |
| Low energy availability metabolic diet (5-days) | Experimental | Behavioral: 5-day controlled metabolic dietary intake20 kcal/kg of FFM/day; 28% fat, 15% protein, 57% carbohydrate |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Female
- Age 18-30
- Body mass index between 18.5-24.9 OR 30-45
- Have regular menstrual cycles between 18-40 days over the past 6 months
- Weight stable (not gained or lost 5kg) in the past 3 months
Key exclusion criteria (5 listed)
- Using hormonal birth control currently or within the past three months
- Polycystic ovary syndrome (current or past diagnosis)
- Pregnant, lactating, planning to become pregnant in next 6 months
- Engaging in regular intentional aerobic exercise
- Significant medical issues (e.g.,cardiovascular disease or diabetes)
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 |
|---|---|---|
| 5-day controlled metabolic dietary intakeOver 5-days, all food will be provided from the metabolic kitchen and participants will be instructed to eat all of the food provided each day and only the food provided each day. | Behavioural | Energy balanced metabolic diet (5-days), Low energy availability metabolic diet (5-days) |
Primary outcome
Change from baseline in stimulated pituitary function, as measured by Luteinizing hormone (LH) area under the curve (AUC) over two hours following pituitary stimulation with a physiologic bolus intravenous dose of gonadorelin acetate
Time frame: Baseline, ~4-weeks, ~8-weeks (visits timed to to days 1-5 of the menstrual cycle)
Within-participant changes in response to both conditions will be measured, with lower LH AUC indicating a blunted pituitary response to stimulation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2023.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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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.
Ann E Caldwell, PhD principal investigator
University of Colorado Anschutz School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Hypogonadotropic Hypogonadism, 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 5 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: status not confirmed, as of the sponsor's last update on 11 Apr 2023. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Trish Coordinator, MS, RD (303-724-6821, HoWL@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in stimulated pituitary function, as measured by Luteinizing hormone (LH) area under the curve (AUC) over two hours following pituitary stimulation with a physiologic bolus intravenous dose of gonadorelin acetate (time frame: Baseline, ~4-weeks, ~8-weeks (visits timed to to days 1-5 of the menstrual cycle)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Apr 2023.