Brain-Heart Axis in Type 2 Diabetes Mellitus
Recruiting · NCT07757308 · Observational (researchers observe without assigning treatment) · Lead sponsor: Hacettepe University
View the official record on ClinicalTrials.gov →What this trial is about
Type 2 Diabetes Mellitus (T2DM) is associated with chronic hyperglycemia and metabolic disturbances that affect not only glucose metabolism but also the central nervous system, autonomic nervous system, and cardiovascular function. Growing evidence suggests that individuals with T2DM are at increased risk of cognitive impairment, autonomic dysfunction, reduced functional capacity, and psychological distress. However, the interactions among metabolic status, brain activity, cardiac autonomic regulation, functional performance, and mental health have not been comprehensively investigated within a single study. This cross-sectional study aims to investigate the relationships between metabolic abnormalities and brain-heart axis function in adults with T2DM. Approximately 50 participants aged 40-65 years with a confirmed diagnosis of T2DM will undergo comprehensive assessments, including resting electroencephalography (EEG), heart rate variability (HRV), functional capacity tests (1-Minute Sit-to-Stand Test and 6-Minute Walk Test), cognitive function using the Montreal Cognitive Assessment (MoCA), physical activity using the International Physical Activity Questionnaire-Short Form (IPAQ-SF), and psychological status using the Depression Anxiety Stress Scale (DASS-21). Clinical and metabolic variables, including HbA1c, fasting blood glucose, lipid profile, and inflammatory markers, will also be collected from medical records. The primary objective is to determine whether metabolic disturbances are associated with alterations in EEG-derived brain activity and HRV-derived autonomic function and whether these changes are related to cognitive performance, functional capacity, physical activity, and psychological well-being. Correlation analyses, path analysis, and structural equation modeling will be used to explore direct and indirect relationships among these variables. The findings are expected to improve understanding of the brain-heart axis in T2DM and provide evidence for multidimensional assessment strategies to support early detection of neurocardiac dysfunction and optimize rehabilitation approaches.
Who can take part
Inclusion criteria
- Adults aged 40 to 75 years.
- Confirmed diagnosis of Type 2 Diabetes Mellitus (T2DM).
- Able to understand the study procedures and provide written informed consent.
- Able to complete all planned clinical, neurophysiological, cognitive, and functional assessments.
Exclusion criteria
- Diagnosis of neurological, psychiatric, orthopedic, or other systemic diseases that may influence study outcomes.
- Cognitive or psychological impairment preventing completion of study assessments.
- History of recent surgery or acute medical condition affecting participation.
- Inability or unwillingness to provide written informed consent.
- Inability to complete the assessment protocol.
Where it is running
1 location listed.
- Munzur University Faculty of Health Sciences - Tunceli, Turkey (Türkiye)