Biomarkers in EV Associated With Marrow Adiposity in Anorexia

NCT06712485 | Not Yet Recruiting

• 1 other identifier: FEIOMM24_001
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Extracellular Vesicles; Bone Deterioration; Biomarkers; Bone Marrow Adipose Tissue; Nutritional Deficiencies

Outcome Measures

Primary Outcomes (1)

• Biomarkers related to medullary adiposity

  Blood samples to isolate extracellular vesicles for omics studies

  1 day

Secondary Outcomes (2)

• Bone Mineral Density

  1 day

• Body Composition

  1 day

Study Arms (3)

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maimónides Biomedical Research Institute of Córdoba: lead
• Hospital Universitario Reina Sofia de Cordoba: collaborator

Study Sites (1)

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

Córdoba, Córdoba, 14004, Spain

Location

Related Publications (6)

• 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.

  PMID: 19268721 BACKGROUND

• 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.

  PMID: 21963155 BACKGROUND

• 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.

  PMID: 27695438 BACKGROUND

• 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.

  PMID: 19850693 BACKGROUND

• 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.

  PMID: 22508185 BACKGROUND

• 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.

  PMID: 29101431 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Serum

MeSH Terms

Conditions

Anorexia Nervosa; Malnutrition

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Marta Camacho-Cardenosa, pHd

  Maimonides Biomedical Research Institute of Córdoba

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marta Camacho-Cardenosa, pHd

CONTACT

+34 957213814; marta.camacho@imibic.org

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: December 2, 2024
• Study Start: May 15, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): July 31, 2026
• Last Updated: May 7, 2025

Record last verified: 2024-11

Locations

ES (1)