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Идёт набор NCT05885724

Novel Targetable BIOmarkers in ANorexia NervosA

— Наблюдательное Anorexia Nervosa Anorexia Nervosa Restricting Type

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Anorexia Nervosa, Anorexia Nervosa Restricting Type. Базовые параметры: 18 лет — 60 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Швейцария
Следующий шаг
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Официальное название

Novel Targetable BIOmarkers in ANorexia NervosA - BIOANNA

Обзор

The overall aim of this present study is to evaluate Growth Differentiation Factor-15 (GDF-15) and inflammatory cytokines as a possible novel and readily treatable target for the successful therapy of Anorexia Nervosa (AN). Therefore, GDF-15, neuronal and glial damage markers such as Neurofilament light chain (Nfl) and Glial fibrillary acidic protein (GFAP) and cytokines (such as Tumor necrosis factor alpha (TNF-α), Interleukin-6 (IL-6), and Interleukin 1β (IL-1β) levels will be assessed in the serum as well as in the cerebrospinal fluid of patients with diagnosed restrictive AN with and without exercising behavior compared to sex- and age-matched healthy controls to consolidate previous findings and to identify the main site of production of GDF-15 and cytokines in AN.

Подробное описание

In addition, assessment of body composition via Dual Energy X-ray Absorptiometry (DEXA )scans and of energy expenditure via indirect calorimetry, respectively, will allow us to correlate GDF-15, Nfl and GFAP and cytokine levels with lean and fat mass measures as well as with energy expenditure, respectively, of AN patients and the matched controls. Overall, this will allow us to comprehensively evaluate GDF-15 and cytokines as possible novel targets for the treatment of AN and to set the basis for a follow up study using available neutralizing antibodies or inhibitors against GDF-15 and the respective cytokines for the treatment of patients with AN, respectively. This will also allow for a more tailored, individualized treatment approach of AN in the future. Our findings will hopefully challenge the viewpoint that AN is a condition which can be controlled by the individual but demonstrate that AN is a biological disease that should be treated by targeting the right biological players in addition to psychiatric treatment.

Первичные конечные точки

  • Growth Differentiation Factor-15 (GDF-15) (pg/ml) level in the plasma [Срок оценки: one time assessment 3 weeks after screening]
  • Growth Differentiation Factor-15 (GDF-15) (pg/ml) level in the cerebrospinal fluids [Срок оценки: one time assessment 3 weeks after screening]

Критерии участия

N=8 adult male and female patients with confirmed diagnosis of anorexia nervosa restrictive type, non-exercising subtype

Критерии включения

  • Age 18-60 years
  • Written informed consent
  • BMI 10-16 kg/m2

N=8 adult male and female patients with confirmed diagnosis of anorexia nervosa restrictive type, exercising subtype will be included in this study.

Критерии включения

  • Age 18-60 years
  • Written informed consent
  • BMI 10-16 kg/m2

N=16 control participants, sex- and age-matched to the individual anorexia nervosa patients.

Критерии включения

  • Age 18-60 years
  • Written informed consent
  • BMI 19-24.9 kg/m2

Критерии исключения

  • Use of antibiotics within the last 31 days
  • Current illicit drug abuse including daily marijuana or CBD (cannabidiol) consumption (≤ 24 g of alcohol per day allowed)
  • Any kind of severe chronic disease other than AN (e.g. active cancer disease)
  • Severe renal impairment (e.g. estimated glomerular filtration rate <30 ml/min/m2) if resulting from another disease than AN
  • Known liver cirrhosis or other severe liver impairment if resulting from another disease than AN
  • Acute upper respiratory tract infection within the last 31 days
  • Uncontrolled dysthyroidism
  • Uncontrolled hypertension
  • Current pregnancy/lactation or current treatment for in vitro fertilization
  • Inability to understand the study information, to sign the consent form and to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Швейцария · 1 центр
  • University Hospital Basel — Basel

Идентификаторы

NCT: NCT05885724 · 2023-00513, kt23Timper2

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗