Clinical trial NCT06712485: Biomarkers in EV Associated With Marrow Adiposity in Anorexia
Official title: Identification of Biomarkers in Extracellular Vesicles Associated With Marrow Adiposity and Bone Deterioration Caused by Nutritional Deficiencies
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Anorexia Nervosa Restricting Type
Anorexia Nervosa (DSM-IV Revised Criteria)
Keywords: Extracellular Vesicles
Bone Deterioration
Biomarkers
Bone Marrow Adipose Tissue
Nutritional Deficiencies
Lead sponsor: Maimónides Biomedical Research Institute of Córdoba
Sponsor class: OTHER
Collaborators: name: Hospital Universitario Reina Sofia de Cordoba
First posted: 2024-12-02
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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).

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Biomarkers related to medullary adiposity
timeFrame: 1 day
Secondary outcomes:
measure: Bone Mineral Density
timeFrame: 1 day
measure: Body Composition
timeFrame: 1 day
Other outcomes:
Locations:
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofía, Edificio IMIBIC, Avd. Menedez Pdial, s/n
Study officials:
affiliation: Maimonides Biomedical Research Institute of Córdoba
name: Marta Camacho-Cardenosa, pHd
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.
citation: 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.
citation: 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.