Magnetic Resonance Imaging in Metabolic Diseases
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Metabolic Diseases. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Structural differences in the brain between patients with metabolic diseases and healthy controls [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.]
- Functional differences in the brain between patients with metabolic diseases and healthy controls [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.]
- Metabolic differences in the brain between patients with metabolic diseases and healthy controls [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.]
- Body Composition derived from magnetic resonance imaging [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.]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Germany · 1 center
- University Hospital Ulm — Ulm
Identifiers
NCT: NCT06709846 · 221/24