Magnetic Resonance Imaging in Metabolic Diseases

Обзор

This study aims to leverage structural, functional, and metabolic magnetic resonance imaging (MRI) of the brain to identify imaging features that correlate with clinical parameters. It is hypothesized that individuals with metabolic diseases exhibit distinct functional and structural brain differences compared to healthy controls. These differences may evolve over time due to changes in whole-body metabolism or body weight, influenced by factors such as the natural progression of the disease or therapeutic interventions. Additionally, potential brain changes may correlate with body composition metrics, such as the fat content of specific body compartments. This is a prospective, single-center study conducted at Ulm University Hospital, designed to track the clinical and imaging histories of patients with metabolic diseases and compare them to healthy individuals. Eligible participants include adults (aged 18 and older) capable of providing informed consent. Recruitment will occur through routine clinical care or existing research studies. To provide a comprehensive understanding, the study will include both cross-sectional analyses and longitudinal follow-up of participants, integrating repeated assessments during routine medical visits.

Первичные конечные точки

• Structural differences in the brain between patients with metabolic diseases and healthy controls [Срок оценки: cross-sectional and up to 5 years, depending on regular visits as part of routine patient care that, however, are not part of this scientific project.]
• Functional differences in the brain between patients with metabolic diseases and healthy controls [Срок оценки: cross-sectional and up to 5 years, depending on regular visits as part of routine patient care that, however, are not part of this scientific project.]
• Metabolic differences in the brain between patients with metabolic diseases and healthy controls [Срок оценки: cross-sectional and up to 5 years, depending on regular visits as part of routine patient care that, however, are not part of this scientific project.]
• Body Composition derived from magnetic resonance imaging [Срок оценки: cross-sectional and up to 5 years, depending on regular visits as part of routine patient care that, however, are not part of this scientific project.]

Критерии участия

Критерии включения

• patients with metabolic diseases OR
• healthy control participants without metabolic diseases
• written consent

Критерии исключения

• History of traumatic brain injuries
• preterm birth (≤34th week of pregnancy) of the study participant
• history of brain surgery
• structural brain changes (e.g., tumors, congenital abnormalities, etc.)
• neurological developmental disorders (e.g., autism spectrum disorders, learning disabilities, intellectual disability)
• epilepsy,
• drug addiction
• other severe neurological or severe psychiatric disorders (e.g., schizophrenia
• pregnancy
• acute clinically relevant inflammatory diseases
• acute systemic or local infections
• severe or etiologically unclear diseases depending on the principle investigators judgement
• pre-existing intellectual impairment
• significant limitations in language comprehension
• absence of written consent
• general exclusion criteria for MRI imaging (e.g., pacemaker systems, neurostimulators, cochlear implants)

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Германия · 1 центр

• University Hospital Ulm — Ulm

Идентификаторы

NCT: NCT06709846 · 221/24

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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