- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT06712485
Biomarkører i EV associeret med Marrow Adiposity i Anoreksi (VE_BMAT_AN)
Identifikation af biomarkører i ekstracellulære vesikler forbundet med marvfedt og knogleforringelse forårsaget af ernæringsmangler
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.
Studieoversigt
Status
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Marta Camacho-Cardenosa, pHd
- Telefonnummer: +34 957213814
- E-mail: marta.camacho@imibic.org
Studiesteder
-
-
Córdoba
-
Córdoba, Córdoba, Spanien, 14004
- Hospital Universitario Reina Sofía, Edificio IMIBIC, Avd. Menedez Pdial, s/n
-
Kontakt:
- Marta Camacho-Cardenosa
- Telefonnummer: +34 957213814
- E-mail: marta.camacho@imibic.org
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
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).
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: CASE_CONTROL
- Tidsperspektiver: CROSS_SECTIONAL
Kohorter og interventioner
Gruppe / kohorte |
|---|
|
AN
Patients with Anorexia Nervosa diagnosed according to the DSM-V criteria. |
|
AN-R
Patients recovered from Anorexia Nervosa |
|
CON
Healthy subjects of the same age and gender as all other groups |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Biomarkers related to medullary adiposity
Tidsramme: 1 day
|
Blood samples to isolate extracellular vesicles for omics studies |
1 day
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Bone Mineral Density
Tidsramme: 1 day
|
Bone mineral density measured by densitometry |
1 day
|
|
Body Composition
Tidsramme: 1 day
|
Fat and muscle mass measured by ultrasound |
1 day
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Marta Camacho-Cardenosa, pHd, Maimonides Biomedical Research Institute of Córdoba
Publikationer og nyttige links
Generelle publikationer
- Griffith JF, Yeung DK, Ahuja AT, Choy CW, Mei WY, Lam SS, Lam TP, Chen ZY, Leung PC. A study of bone marrow and subcutaneous fatty acid composition in subjects of varying bone mineral density. Bone. 2009 Jun;44(6):1092-6. doi: 10.1016/j.bone.2009.02.022. Epub 2009 Mar 5.
- Goto H, Hozumi A, Osaki M, Fukushima T, Sakamoto K, Yonekura A, Tomita M, Furukawa K, Shindo H, Baba H. Primary human bone marrow adipocytes support TNF-alpha-induced osteoclast differentiation and function through RANKL expression. Cytokine. 2011 Dec;56(3):662-8. doi: 10.1016/j.cyto.2011.09.005. Epub 2011 Oct 1.
- 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.
- 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.
- 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.
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- FEIOMM24_001
- FEIOMM24_001 (Andet bevillings-/finansieringsnummer: Fundación Española de Investigación Ósea y Metabolismo Mineral)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
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