Biomarkers in EV Associated With Marrow Adiposity in Anorexia

Not yet recruiting

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

• Registration Number: NCT06712485
• Lead Sponsor: Maimónides Biomedical Research Institute of Córdoba

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-26
• Study First Submitted QC: 2024-11-26
• Study First Posted: 2024-12-02
• Last Update Submitted: 2025-05-05
• Last Update Posted: 2025-05-07
• Study Start: 2025-05-15
• Primary Completion: 2025-12-31
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Biomarkers related to medullary adiposity	1 day	Blood samples to isolate extracellular vesicles for omics studies

Secondary Outcome Measures

Name	Time	Method
Bone Mineral Density	1 day	Bone mineral density measured by densitometry
Body Composition	1 day	Fat and muscle mass measured by ultrasound

Trial Locations

Locations (1)

Hospital Universitario Reina Sofía, Edificio IMIBIC, Avd. Menedez Pdial, s/n; 🇪🇸 Córdoba, Spain