Anorexia Nervosa Restricting TypeVE_BMAT_ANNCT06712485
Biomarkers in EV Associated With Marrow Adiposity in Anorexia
An observational study of Anorexia Nervosa Restricting Type and Anorexia Nervosa (DSM-IV Revised Criteria), run by Maimónides Biomedical Research Institute of Córdoba at 1 site in Spain.
Trial 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?… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Anorexia Nervosa Restricting Type, Anorexia Nervosa (DSM-IV Revised Criteria)
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 15 Jan 2027to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The study population will consist of patients diagnosed with active anorexia nervosa according to DSM-V criteria (AN group), with a clinical history in the Clinical Management Unit of Endocrinology and Nutrition of the HURS, patients recovered from the disease (AN-R group) and healthy population of the same age and gender as the patients in the previous groups (CON group).
Who may be able to join
- 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%.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Hospital Universitario Reina Sofía, Edificio IMIBIC, Avd. Menedez Pdial, s/n
Córdoba, Córdoba, 14004
Marta Camacho-Cardenosa, +34 957213814, marta.camacho@imibic.org
About this study
Official title: Identification of Biomarkers in Extracellular Vesicles Associated With Marrow Adiposity and Bone Deterioration Caused by Nutritional Deficiencies
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.
- Keywords
- Extracellular Vesicles, Bone Deterioration, Biomarkers, Bone Marrow Adipose Tissue, Nutritional Deficiencies
- Medical subject headings
- Anorexia Nervosa, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| AN | Patients with Anorexia Nervosa diagnosed according to the DSM-V criteria. | |
| AN-R | Patients recovered from Anorexia Nervosa | |
| CON | Healthy subjects of the same age and gender as all other groups |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarkers related to medullary adiposity
Blood samples to isolate extracellular vesicles for omics studies
Measured: 1 day
Secondary outcomes (2)
Bone Mineral Density
Bone mineral density measured by densitometry
Measured: 1 day
Body Composition
Fat and muscle mass measured by ultrasound
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2024
- Study start15 Jan 2027 (estimated)
- Primary completion15 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Anorexia Nervosa Restricting TypeStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maimónides Biomedical Research Institute of Córdoba
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario Reina Sofia de Cordoba
- Responsible party
- Sponsor
- Investigators
- Marta Camacho-Cardenosa, pHd, Principal investigator, Maimonides Biomedical Research Institute of Córdoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06712485
- Sponsor's protocol ID
- FEIOMM24_001
- Other IDs
- FEIOMM24_001
- Acronym
- VE_BMAT_AN
- Status last verified
- Nov 2026
- First submitted
- 26 Nov 2024
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Griffith JF, Yeung DK, Ahuja AT, Choy CW, Mei WY, Lam SS, Lam TP, Chen ZY, Leung PC. A study of bone marrow and subcutaneous fatty acid composition in subjects of varying bone mineral density. Bone. 2009 Jun;44(6):1092-6. doi: 10.1016/j.bone.2009.02.022. Epub 2009 Mar 5.
PubMed 19268721Goto H, Hozumi A, Osaki M, Fukushima T, Sakamoto K, Yonekura A, Tomita M, Furukawa K, Shindo H, Baba H. Primary human bone marrow adipocytes support TNF-alpha-induced osteoclast differentiation and function through RANKL expression. Cytokine. 2011 Dec;56(3):662-8. doi: 10.1016/j.cyto.2011.09.005. Epub 2011 Oct 1.
PubMed 21963155Ghali O, Al Rassy N, Hardouin P, Chauveau C. Increased Bone Marrow Adiposity in a Context of Energy Deficit: The Tip of the Iceberg? Front Endocrinol (Lausanne). 2016 Sep 16;7:125. doi: 10.3389/fendo.2016.00125. eCollection 2016.
PubMed 27695438Fazeli PK, Bredella MA, Misra M, Meenaghan E, Rosen CJ, Clemmons DR, Breggia A, Miller KK, Klibanski A. Preadipocyte factor-1 is associated with marrow adiposity and bone mineral density in women with anorexia nervosa. J Clin Endocrinol Metab. 2010 Jan;95(1):407-13. doi: 10.1210/jc.2009-1152. Epub 2009 Oct 22.
PubMed 19850693Fazeli PK, Bredella MA, Freedman L, Thomas BJ, Breggia A, Meenaghan E, Rosen CJ, Klibanski A. Marrow fat and preadipocyte factor-1 levels decrease with recovery in women with anorexia nervosa. J Bone Miner Res. 2012 Sep;27(9):1864-71. doi: 10.1002/jbmr.1640.
PubMed 22508185Ambrosi TH, Schulz TJ. The emerging role of bone marrow adipose tissue in bone health and dysfunction. J Mol Med (Berl). 2017 Dec;95(12):1291-1301. doi: 10.1007/s00109-017-1604-7. Epub 2017 Nov 3.
PubMed 29101431
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Biomarkers in Extracellular Vesicles Associated With Marrow Adiposity and Bone Deterioration Caused by Nutritional Deficiencies
- ClinicalTrials.gov ID
- NCT06712485
- Acronym / sponsor ID
- VE_BMAT_AN / FEIOMM24_001
- Keywords
- Extracellular Vesicles, Bone Deterioration, Biomarkers, Bone Marrow Adipose Tissue, Nutritional Deficiencies
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Maimónides Biomedical Research Institute of CórdobaUniversity, hospital or other
- Collaborators
- Hospital Universitario Reina Sofia de Cordoba
- Study start
- 15 Jan 2027 (estimated)
- Primary completion
- 15 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 2 Dec 2024 (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 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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AN | – | –Patients with Anorexia Nervosa diagnosed according to the DSM-V criteria. |
| AN-R | – | –Patients recovered from Anorexia Nervosa |
| CON | – | –Healthy subjects of the same age and gender as all other groups |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population will consist of patients diagnosed with active anorexia nervosa according to DSM-V criteria (AN group), with a clinical history in the Clinical Management Unit of Endocrinology and Nutrition of the HURS, patients recovered from the disease (AN-R group) and healthy population of the same age and gender as the patients in the previous groups (CON group).
Key inclusion criteria (13 listed)
- 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.
- Achieved weight gain of more than 85%.
- Normal menstruation in the last 3 months.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Biomarkers related to medullary adiposity
Time frame: 1 day
Blood samples to isolate extracellular vesicles for omics studies
2 secondary outcomes
Bone Mineral Density
Time frame: 1 day
Body Composition
Time frame: 1 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Background: PubMed 19268721Griffith JF, Yeung DK, Ahuja AT, Choy CW, Mei WY, Lam SS, Lam TP, Chen ZY, Leung PC. A study of bone marrow and subcutaneous fatty acid composition in subjects of varying bone mineral density. Bone. 2009 Jun;44(6):1092-6. doi: 10.1016/j.bone.2009.02.022. Epub 2009 Mar 5.
- Background: PubMed 21963155Goto H, Hozumi A, Osaki M, Fukushima T, Sakamoto K, Yonekura A, Tomita M, Furukawa K, Shindo H, Baba H. Primary human bone marrow adipocytes support TNF-alpha-induced osteoclast differentiation and function through RANKL expression. Cytokine. 2011 Dec;56(3):662-8. doi: 10.1016/j.cyto.2011.09.005. Epub 2011 Oct 1.
- Background: PubMed 27695438Ghali O, Al Rassy N, Hardouin P, Chauveau C. Increased Bone Marrow Adiposity in a Context of Energy Deficit: The Tip of the Iceberg? Front Endocrinol (Lausanne). 2016 Sep 16;7:125. doi: 10.3389/fendo.2016.00125. eCollection 2016.
- Background: PubMed 19850693Fazeli PK, Bredella MA, Misra M, Meenaghan E, Rosen CJ, Clemmons DR, Breggia A, Miller KK, Klibanski A. Preadipocyte factor-1 is associated with marrow adiposity and bone mineral density in women with anorexia nervosa. J Clin Endocrinol Metab. 2010 Jan;95(1):407-13. doi: 10.1210/jc.2009-1152. Epub 2009 Oct 22.
- Background: PubMed 22508185Fazeli PK, Bredella MA, Freedman L, Thomas BJ, Breggia A, Meenaghan E, Rosen CJ, Klibanski A. Marrow fat and preadipocyte factor-1 levels decrease with recovery in women with anorexia nervosa. J Bone Miner Res. 2012 Sep;27(9):1864-71. doi: 10.1002/jbmr.1640.
- Background: PubMed 29101431Ambrosi TH, Schulz TJ. The emerging role of bone marrow adipose tissue in bone health and dysfunction. J Mol Med (Berl). 2017 Dec;95(12):1291-1301. doi: 10.1007/s00109-017-1604-7. Epub 2017 Nov 3.
- Individual participant dataSharing planned: Undecided
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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.
Marta Camacho-Cardenosa, pHd principal investigator
Maimonides Biomedical Research Institute of Córdoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anorexia Nervosa Restricting Type and Anorexia Nervosa (DSM-IV Revised Criteria), run by Maimónides Biomedical Research Institute of Córdoba at 1 site in Spain.
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 13 inclusion and 3 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: opening soon, as of the sponsor's last update on 4 Nov 2026. 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 Spain. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marta Camacho-Cardenosa, pHd (+34 957213814, marta.camacho@imibic.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biomarkers related to medullary adiposity (time frame: 1 day). 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 NCT06712485, which also lists 6 linked publications.
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 4 Nov 2026.