Metabolic DiseasesNCT06709846
Magnetic Resonance Imaging in Metabolic Diseases
An observational study of Metabolic Diseases, run by University of Ulm at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Metabolic Diseases
- How many people
- 126 participants
- Where
- 1 siteGermany
- Study dates
- 8 Feb 2025to Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- patients with metabolic diseases OR
- healthy control participants without metabolic diseases
- written consent
Who cannot join
- 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,
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- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Ulm
Ulm, 89081
Martin Heni, +4973150044505, martin.heni@uniklinik-ulm.de
About this study
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
- Medical subject headings
- Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Metabolic Diseases | Not described | |
| Healthy Control Participants | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2024
- Study start8 Feb 2025
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Ulm
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin Heni, University of Ulm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06709846
- Sponsor's protocol ID
- 221/24
- Status last verified
- Feb 2026
- First submitted
- 25 Nov 2024
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance Imaging in Metabolic Diseases
- ClinicalTrials.gov ID
- NCT06709846
- Acronym / sponsor ID
- 221/24
- Conditions
- Metabolic Diseases
- Keywords
- Metabolic Diseases, Magnetic Resonance Imaging, Body Composition
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- University of UlmUniversity, hospital or other
- Study start
- 8 Feb 2025 (actual)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 29 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Metabolic Diseases | – | – |
| Healthy Control Participants | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- patients with metabolic diseases OR
- healthy control participants without metabolic diseases
- written consent
Key exclusion criteria (16 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
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.
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.
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
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic Diseases, run by University of Ulm at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Martin Heni, Prof. Dr. med. (+4973150044505, martin.heni@uniklinik-ulm.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.