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Effects of Metabolic Dysfunction on Functional Capacity and Mental Health Through the Brain-Heart Axis in Type 2 Diabetes Mellitus: A Cross-Sectional Study Based on Electroencephalography and Heart Rate Variability
Sponsor study identifier
observational
46
1 country
1
Study Start
June 25, 2026
Actual (reported)Primary Completion
September 15, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 25, 2026
Actual (reported)August 2, 2026
Actual (reported)August 11, 2026
Actual (reported)September 15, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Heart Rate Variability
Resting cardiac autonomic function will be assessed using heart rate variability (HRV). Time-domain (RMSSD, SDNN, pNN50, mean RR interval) and frequency-domain (LF, HF, LF/HF ratio, total power) parameters will be analyzed from resting recordings.
Baseline (single assessment visit)
Delta Band Power
Resting electroencephalography (EEG) assessment of cortical electrical activity. Delta band power will be quantified from resting EEG recordings. Higher or lower values indicate changes in cortical electrical activity depending on the analyzed brain region.
Baseline
Theta Band Power
Resting electroencephalography (EEG) assessment of cortical electrical activity. Theta band power will be quantified from resting EEG recordings. Higher or lower values indicate changes in cortical electrical activity depending on the analyzed brain region.
Baseline
Cognitive Function
Baseline (single assessment visit)
Physical Activity Level
Baseline (single assessment visit)
One-Minute Sit-to-Stand Test
Baseline
Six-Minute Walk Test
Baseline
Depression Symptoms (DASS-21 Depression)
Baseline
Adults aged 40-65 years with a confirmed diagnosis of Type 2 Diabetes Mellitus (T2DM) will participate in this observational cross-sectional study. Participants will undergo comprehensive assessments including electroencephalography (EEG), heart rate variability (HRV), functional capacity (1-Minute Sit-to-Stand Test and 6-Minute Walk Test), cognitive function (Montreal Cognitive Assessment), physical activity (International Physical Activity Questionnaire-Short Form), and psychological status (Depression Anxiety Stress Scale-21 and Hospital Anxiety and Depression Scale). Clinical and metabolic parameters, including HbA1c, fasting blood glucose, lipid profile, and inflammatory markers, will be obtained from medical records. No experimental intervention will be administered; all participants will undergo a single assessment session.
The study population will consist of approximately 50 adults aged 40-75 years with a confirmed diagnosis of Type 2 Diabetes Mellitus (T2DM). Participants will be recruited from internal medicine, endocrinology, and family medicine outpatient clinics of the participating institutions. Eligible individuals must be able to provide written informed consent and complete all neurophysiological, cognitive, functional, and psychological assessments. Recruitment will be based on voluntary participation.
Munzur University Faculty of Health Sciences
Tunceli, Turkey (Türkiye)
Schaffarczyk M, Rogers B, Reer R, Gronwald T. Validity of the Polar H10 Sensor for Heart Rate Variability Analysis during Resting State and Incremental Exercise in Recreational Men and Women. Sensors (Basel). 2022 Aug 30;22(17):6536. doi: 10.3390/s22176536.
First Submitted
August 2, 2026
First Posted
August 11, 2026
Study Start
June 25, 2026
Actual (reported)Primary Completion
September 15, 2026
Estimated (date passed)Alpha Band Power
Resting electroencephalography (EEG) assessment of cortical electrical activity. Alpha band power will be quantified from resting EEG recordings. Higher or lower values indicate changes in cortical electrical activity depending on the analyzed brain region.
Baseline
Beta Band Power
Resting electroencephalography (EEG) assessment of cortical electrical activity. Beta band power will be quantified from resting EEG recordings. Higher or lower values indicate changes in cortical electrical activity depending on the analyzed brain region.
Baseline
Frontal Alpha Asymmetry
Resting electroencephalography (EEG) assessment of frontal alpha asymmetry calculated from bilateral frontal electrode recordings. Changes in frontal alpha asymmetry reflect alterations in hemispheric cortical activity.
Baseline
Functional Connectivity
Resting electroencephalography (EEG) assessment of functional connectivity between cortical regions using predefined EEG connectivity metrics.
Baseline
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
August 11, 2026
Record last verified: 2026-08
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Source: ClinicalTrials.gov.
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