Magnetic Resonance Imaging in Metabolic Diseases

NCT ID: NCT06709846

Last Updated: 2025-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

126 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-02-08

Study Completion Date

2029-12-31

Brief Summary

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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

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Conditions

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Metabolic Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with Metabolic Diseases

No interventions assigned to this group

Healthy Control Participants

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Ulm

OTHER

Sponsor Role lead

Responsible Party

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Martin Heni

Prof. Dr. med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Hospital Ulm

Ulm, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Martin Heni, Prof. Dr. med.

Role: CONTACT

+4973150044505

Nico Sollmann, PD Dr. Dr. med.

Role: CONTACT

+49 (0)731 500-61001

Facility Contacts

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Martin Heni

Role: primary

+4973150044505

Other Identifiers

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221/24

Identifier Type: -

Identifier Source: org_study_id

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