Clinical trial NCT06709846: Magnetic Resonance Imaging in Metabolic Diseases
Official title: Magnetic Resonance Imaging in Metabolic Diseases
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Metabolic Diseases
Keywords: Metabolic Diseases
Magnetic Resonance Imaging
Body Composition
Lead sponsor: University of Ulm
Sponsor class: OTHER
First posted: 2024-11-29
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Besides healthy controls, we will include patients who are treated for metabolic diseases at Ulm University Hospital. After the scan for cross-sectional assessment (baseline), patients who are clinically followed up at Ulm University Hospital will be offered follow-up scans, depending on changes in body weight or metabolism.

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Structural differences in the brain between patients with metabolic diseases and healthy controls
timeFrame: 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.
measure: Functional differences in the brain between patients with metabolic diseases and healthy controls
timeFrame: 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.
measure: Metabolic differences in the brain between patients with metabolic diseases and healthy controls
timeFrame: 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.
measure: Body Composition derived from magnetic resonance imaging
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Ulm
country: Germany
facility: University Hospital Ulm
Study officials:
References: