Magnetic Resonance Imaging in Metabolic Diseases

Recruiting

• Conditions: Metabolic Diseases

• Registration Number: NCT06709846
• Lead Sponsor: University of Ulm

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-25
• Study First Submitted QC: 2024-11-25
• Study First Posted: 2024-11-29
• Study Start: 2025-02-08
• Last Update Submitted: 2025-03-20
• Last Update Posted: 2025-03-25
• Primary Completion: 2029-12
• Study Completion: 2029-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 126

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Structural differences in the brain between patients with metabolic diseases and healthy controls	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.	Comparison of brain anatomical magnetic resonance imaging sequences (T1- and T2-weighted sequences) between patients with metabolic diseases and healthy controls give insights into structural features in patients with metabolic diseases.
Functional differences in the brain between patients with metabolic diseases and healthy controls	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.	Comparison of brain functional magnetic resonance imaging between patients with metabolic diseases and healthy controls will give insights into functional aspects of patients with metabolic diseases.
Metabolic differences in the brain between patients with metabolic diseases and healthy controls	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.	Comparison of brain metabolic magnetic resonance imaging (Chemical Exchange Saturation Transfer (CEST)", MR-spectroscopy) between patients with metabolic diseases and healthy controls give insights into metabolic features in patients with metabolic diseases
Body Composition derived from magnetic resonance imaging	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.	Magnetic resonance imaging (DIXON sequence or fat-water imaging to determine the "Proton Density Fat Fraction" (PDFF)) will be used to determine the fat content in the different compartments of the whole body.

Trial Locations

Locations (1)

University Hospital Ulm; 🇩🇪 Ulm, Germany