跳至主要内容
临床试验/NCT06709846
NCT06709846
招募中
不适用

Magnetic Resonance Imaging in Metabolic Diseases

University of Ulm1 个研究点 分布在 1 个国家目标入组 126 人2025年2月8日

概览

阶段
不适用
干预措施
Patients with Metabolic Diseases
疾病 / 适应症
Metabolic Diseases
发起方
University of Ulm
入组人数
126
试验地点
1
主要终点
Structural differences in the brain between patients with metabolic diseases and healthy controls
状态
招募中
最后更新
2个月前

概览

简要总结

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.

注册库
clinicaltrials.gov
开始日期
2025年2月8日
结束日期
2029年12月1日
最后更新
2个月前
研究类型
Observational
性别
All

研究者

发起方
University of Ulm
责任方
Principal Investigator
主要研究者

Martin Heni

Prof. Dr. med.

University of Ulm

入排标准

入选标准

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

排除标准

  • 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

研究组 & 干预措施

Patients with Metabolic Diseases

Healthy Control Participants

结局指标

主要结局

Structural differences in the brain between patients with metabolic diseases and healthy controls

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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.

研究点 (1)

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