Biomarkers in EV Associated With Marrow Adiposity in Anorexia (VE_BMAT_AN)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Anorexia Nervosa Restricting Type; Anorexia Nervosa (DSM-IV Revised Criteria)

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Marta Camacho-Cardenosa, pHd; Phone Number: +34 957213814; Email: marta.camacho@imibic.org

Study Locations

• Spain
  • Córdoba, Spain, 14004
    • Hospital Universitario Reina Sofía, Edificio IMIBIC, Avd. Menedez Pdial, s/n
    • Contact: Marta Camacho-Cardenosa; Phone Number: +34 957213814; Email: marta.camacho@imibic.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• 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).

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biomarkers related to medullary adiposity	Blood samples to isolate extracellular vesicles for omics studies	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bone Mineral Density	Bone mineral density measured by densitometry	1 day
Body Composition	Fat and muscle mass measured by ultrasound	1 day

Collaborators and Investigators

• Sponsor: Maimónides Biomedical Research Institute of Córdoba
• Collaborators: Hospital Universitario Reina Sofia de Cordoba
• Investigators: Principal Investigator: Marta Camacho-Cardenosa, pHd, Maimónides Biomedical Research Institute of Córdoba

Publications and helpful links

General 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): May 15, 2025
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: November 26, 2024
• First Submitted That Met QC Criteria: November 26, 2024
• First Posted (Actual): December 2, 2024

Study Record Updates

• Last Update Posted (Actual): May 7, 2025
• Last Update Submitted That Met QC Criteria: May 5, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Biomarkers; Nutritional Deficiencies; Extracellular Vesicles; Bone Marrow Adipose Tissue; Bone Deterioration
• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Feeding and Eating Disorders; Anorexia; Anorexia Nervosa
• Other Study ID Numbers: FEIOMM24_001 (Other Grant/Funding Number: Fundación Española de Investigación Ósea y Metabolismo Mineral)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No