Biomarkers in EV Associated With Marrow Adiposity in Anorexia (NCT06712485) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Biomarkers in EV Associated With Marrow Adiposity in Anorexia
Spain30 participantsStarted 2025-05-15
Plain-language summary
The aim of this observational study is to identify biomarkers in extracellular vesicles associated with medullary adiposity occurring in patients with anorexia nervosa. The main question it aims to answer is:
Can this medullary adiposity be associated with the bone deterioration observed in this population?
Participants will be assessed for body composition and a blood sample will be taken by non-invasive techniques.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
For AN group:
* Diagnosis of active AN according to DSM-5 criteria
* BMI of less than 17kg/m2
* Present amenorrhoea in the 3 months prior to the start of the study.
For AN-R group:
* Achieved weight gain of more than 85%.
* Normal menstruation in the last 3 months.
For Control group:
* Population of the same age and gender as the AN and AN-R groups.
* If pubertal population, presenting a chronological age of ± 2 years.
* Normal menstruation
* Normal BMI (\>18.5 kg/m2)
* No presence of previous dietary transtrons.
Exclusion Criteria:
* Not receiving oestrogens, contraceptives or glucocorticoids in the 3 months prior to the start of the study.
* Not to suffer from chronic diseases, such as diabetes, pathologies affecting the bone system or thyroid function.
* Do not take calcium or vitamin supplements.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Biomarkers related to medullary adiposity
Timeframe: 1 day
Trial details
NCT IDNCT06712485
SponsorMaimónides Biomedical Research Institute of Córdoba