Magnetic Resonance Imaging in Metabolic Diseases

University of Ulm

Status: Enrolling

Conditions: Metabolic Diseases

Study type: Observational

Funder types: Other

Identifiers

NCT06709846

221/24

Details and patient eligibility

About

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.

Enrollment: 126 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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)

Trial design

126 participants in 2 patient groups

Patients with Metabolic Diseases

Healthy Control Participants