ClinicalTrials.gg
Not yet recruitingNCT06712485VE_BMAT_ANUpdated Nov 4, 2026

Biomarkers in EV Associated With Marrow Adiposity in Anorexia

An observational study in Anorexia Nervosa Restricting Type and Anorexia Nervosa (DSM-IV Revised Criteria), sponsored by Maimónides Biomedical Research Institute of Córdoba. Not yet recruiting at 1 site in Spain. Per ClinicalTrials.gov, last updated 2026-11-04.

Sponsored by Maimónides Biomedical Research Institute of Córdoba · Observational

Updated Nov 4, 2026Start date movedPrimary completion moved+3 moreGo to Updates ↓
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
30
Sex
All
01

Study 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.

02

Conditions studied

  • Anorexia Nervosa Restricting Type
  • Anorexia Nervosa (DSM-IV Revised Criteria)

Keywords

  • Extracellular Vesicles
  • Bone Deterioration
  • Biomarkers
  • Bone Marrow Adipose Tissue
  • Nutritional Deficiencies
03

In context

Anorexia Nervosa

469 studies on the registry are indexed under Anorexia Nervosa; 127 are open to participants now.

This study's planned enrollment of 30 is below the median of 78 across 142 observational studies indexed under Anorexia Nervosa.

Browse Anorexia Nervosa studies →

Lead sponsor

Maimónides Biomedical Research Institute of Córdoba is the lead sponsor of 79 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

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).

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

For AN group:

  • Diagnosis of active AN according to criteria
  • 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

Exclusion Criteria:

  • Not receiving oestrogens, or 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.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
30 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. Biomarkers related to medullary adiposity

    Blood samples to isolate extracellular vesicles for omics studies

    Time frame: 1 day

Secondary outcomes

  1. Bone Mineral Density

    Bone mineral density measured by densitometry

    Time frame: 1 day

  2. Body Composition

    Fat and muscle mass measured by ultrasound

    Time frame: 1 day

07

Study locations

1 site
  • Hospital Universitario Reina Sofía, Edificio IMIBIC, Avd. Menedez Pdial, s/n
    Córdoba, Córdoba 14004, Spain
08

References and documents

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 19268721 ↗
  • Goto 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 21963155 ↗
  • Ghali 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 27695438 ↗
  • Fazeli 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 19850693 ↗
  • Fazeli 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 22508185 ↗
  • Ambrosi 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 ↗

Individual participant data

Plan to share: Undecided

09

Updates

1 registry update since Sep 25, 2026
Sites
1 site added, 1 site removed
Show site
  • Hospital Universitario Reina Sofía, Edificio IMIBIC, Avd. Menedez Pdial, s/n · Córdoba, Spain
Show 1 removed
  • Hospital Universitario Reina Sofía, Edificio IMIBIC, Avd. Menedez Pdial, s/n · Córdoba, Spain
Nov 4, 2026
Start date
May 15, 2025→Jan 15, 2027
Nov 4, 2026
Primary completion
Dec 31, 2025→Dec 15, 2027
Nov 4, 2026
Study completion
Jul 31, 2026→Dec 31, 2027
Nov 4, 2026
Show all 1 update
  1. Nov 4, 2026
    1 site added, 1 site removed
    Show site
    • Hospital Universitario Reina Sofía, Edificio IMIBIC, Avd. Menedez Pdial, s/n · Córdoba, Spain
    Show 1 removed
    • Hospital Universitario Reina Sofía, Edificio IMIBIC, Avd. Menedez Pdial, s/n · Córdoba, Spain
    Start date May 15, 2025→Jan 15, 2027
    Primary completion Dec 31, 2025→Dec 15, 2027
    Study completion Jul 31, 2026→Dec 31, 2027
    + 3 other changes: index terms, verification date and oversight details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06712485
Lead sponsor
Maimónides Biomedical Research Institute of Córdoba
Collaborators
Hospital Universitario Reina Sofia de Cordoba
Responsible party
Sponsor
First posted
Dec 2, 2024
Start date
Jan 15, 2027 (estimated)
Primary completion
Dec 15, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Nov 4, 2026

Study contacts

Marta Camacho-Cardenosa, pHd
Contact
marta.camacho@imibic.org
+34 957213814
Marta Camacho-Cardenosa, pHd
principal investigator · Maimonides Biomedical Research Institute of Córdoba

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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