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NCT Number: NCT06712485

Biomarkers in EV Associated With Marrow Adiposity in Anorexia

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.

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Key information

Conditions

Anorexia Nervosa Restricting Type Anorexia Nervosa Anorexia Nervosa (DSM-IV Revised Criteria) Feeding and Eating Disorders Malnutrition Mental Disorders Nutrition Disorders Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Córdoba, 14004, Spain

Location contact

Marta Camacho-Cardenosa

CONTACT

[email protected]

+34 957213814

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Biomarkers related to medullary adiposity

Time frame: 1 day

Blood samples to isolate extracellular vesicles for omics studies

Secondary outcomes

Bone Mineral Density

Time frame: 1 day

Bone mineral density measured by densitometry
Body Composition

Time frame: 1 day

Fat and muscle mass measured by ultrasound

Study contacts

Contact information is provided by the study sponsor or research team.

Marta Camacho-Cardenosa, pHd

CONTACT

[email protected]

+34 957213814

Sponsors and collaborators

Lead sponsor

Maimónides Biomedical Research Institute of Córdoba

Other

Collaborators

Hospital Universitario Reina Sofia de Cordoba

Registry information

Official study title

Identification of Biomarkers in Extracellular Vesicles Associated With Marrow Adiposity and Bone Deterioration Caused by Nutritional Deficiencies

Acronym: VE_BMAT_AN

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2026
First posted: Dec 2, 2024
Registry last updated: May 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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