Biomarkers in EV Associated With Marrow Adiposity in Anorexia

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorMaimónides Biomedical Research Institute of Córdoba

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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.

Achieved weight gain of more than 85%.

Disqualifiers

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.

Trial 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).

Trial design

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

30 Participants
are grouped into 3 trial groups
Group A: AN
Group B: AN-R
Group C: CON

Trial outcomes

Primary outcomes

1

Biomarkers related to medullary adiposity

Blood samples to isolate extracellular vesicles for omics studies

Time frame
1 day

Secondary outcomes

1

Bone Mineral Density

Bone mineral density measured by densitometry

Time frame
1 day
2

Body Composition

Fat and muscle mass measured by ultrasound

Time frame
1 day

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Maimónides Biomedical Research Institute of Córdoba

Lead sponsor

Hospital Universitario Reina Sofia de Cordoba

Collaborator

This trial is not recruiting at the moment. You can still explore other options: