Biomarkers in EV Associated With Marrow Adiposity in Anorexia

NCT ID: NCT06712485

Last Updated: 2025-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-05-15

Study Completion Date

2026-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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AN

Patients with Anorexia Nervosa diagnosed according to the DSM-V criteria.

No interventions assigned to this group

AN-R

Patients recovered from Anorexia Nervosa

No interventions assigned to this group

CON

Healthy subjects of the same age and gender as all other groups

No interventions assigned to this group

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hospital Universitario Reina Sofia de Cordoba

OTHER_GOV

Sponsor Role collaborator

Maimónides Biomedical Research Institute of Córdoba

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marta Camacho-Cardenosa, pHd

Role: PRINCIPAL_INVESTIGATOR

Maimonides Biomedical Research Institute of Córdoba

Locations

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Hospital Universitario Reina Sofía, Edificio IMIBIC, Avd. Menedez Pdial, s/n

Córdoba, Córdoba, Spain

Site Status

Countries

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Spain

Central Contacts

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Marta Camacho-Cardenosa, pHd

Role: CONTACT

+34 957213814

Facility Contacts

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Marta Camacho-Cardenosa

Role: primary

+34 957213814

References

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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.

Reference Type BACKGROUND
PMID: 19268721 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21963155 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27695438 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19850693 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22508185 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29101431 (View on PubMed)

Other Identifiers

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FEIOMM24_001

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

FEIOMM24_001

Identifier Type: -

Identifier Source: org_study_id

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