Magnetic Resonance Imaging in Metabolic Diseases

NCT06709846 | Recruiting

• 1 other identifier: 221/24
• Study Type: observational
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Diseases

Keywords

Metabolic Diseases; Magnetic Resonance Imaging; Body Composition

Outcome Measures

Primary Outcomes (4)

• 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.

  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

  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.

  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

  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

  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

  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.

  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.

Study Arms (2)

Patients with Metabolic Diseases

Healthy Control Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Ulm: lead

Study Sites (1)

University Hospital Ulm

Ulm, 89081, Germany

RECRUITING

MeSH Terms

Conditions

Metabolic Diseases

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Central Study Contacts

Martin Heni, Prof. Dr. med.

CONTACT

+4973150044505; martin.heni@uniklinik-ulm.de

Nico Sollmann, PD Dr. Dr. med.

CONTACT

+49 (0)731 500-61001; nico.Sollmann@uniklinik-ulm.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med.

Study Record Dates

• First Submitted: November 25, 2024
• First Posted: November 29, 2024
• Study Start: February 8, 2025
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: February 13, 2026

Record last verified: 2026-02

Locations

DE (1)