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Clinical Trials/NCT06712485
NCT06712485
Not yet recruiting
Not Applicable

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

Maimónides Biomedical Research Institute of Córdoba1 site in 1 country30 target enrollmentMay 15, 2025

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anorexia Nervosa Restricting Type
Sponsor
Maimónides Biomedical Research Institute of Córdoba
Enrollment
30
Locations
1
Primary Endpoint
Biomarkers related to medullary adiposity
Status
Not yet recruiting
Last Updated
12 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 15, 2025
End Date
July 31, 2026
Last Updated
12 months ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Maimónides Biomedical Research Institute of Córdoba
Responsible Party
Sponsor

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.

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.

Outcomes

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(1 day)
  • Body Composition(1 day)

Study Sites (1)

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