Magnetic Resonance Imaging in Metabolic Diseases
ConditionMetabolic Diseases
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Ulm
About this trial
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
This trial accepts healthy volunteersQualifiers
patients with metabolic diseases OR
healthy control participants without metabolic diseases
written consent
Disqualifiers
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.)
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
126 Participants
are grouped into 2 trial groupsGroup A: Patients with Metabolic Diseases
Group B: Healthy Control Participants
Trial outcomes
Primary outcomes
1
Structural differences in the brain between patients with metabolic diseases and healthy controls
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.
Time frame
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.2
Functional differences in the brain between patients with metabolic diseases and healthy controls
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.
Time frame
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.3
Metabolic differences in the brain between patients with metabolic diseases and healthy controls
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
Time frame
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.4
Body Composition derived from magnetic resonance imaging
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.
Time frame
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov