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临床试验/NCT06712485
NCT06712485尚未招募不适用

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

Maimónides Biomedical Research Institute of Córdoba1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年5月15日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
Biomarkers related to medullary adiposity

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Biomarkers related to medullary adiposity

时间窗: 1 day

Blood samples to isolate extracellular vesicles for omics studies

次要结局

  • Bone Mineral Density(1 day)
  • Body Composition(1 day)

研究者

发起方
Maimónides Biomedical Research Institute of Córdoba
申办方类型
Other
责任方
Sponsor

研究点 (1)

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