Brain-Heart Axis in Type 2 Diabetes Mellitus
ConditionType 2 Diabetes Mellitus (T2DM)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40-75
SponsorHacettepe University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
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.
Trial design
Design model
Case-control
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
46 Participants
are grouped into 1 trial groupGroup A: Adults with Type 2 Diabetes Mellitus
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline (single assessment visit)2
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.
Time frame
Baseline3
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.
Time frame
Baseline4
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.
Time frame
BaselineSecondary outcomes
1
Cognitive Function
Cognitive performance assessed using the Montreal Cognitive Assessment. The Montreal Cognitive Assessment is a 30-point cognitive screening tool with scores ranging from 0 to 30. Higher scores indicate better cognitive function (better outcome), whereas lower scores indicate poorer cognitive function (worse outcome).
Time frame
Baseline (single assessment visit)2
Physical Activity Level
Physical activity level assessed using the International Physical Activity Questionnaire-Short Form. The outcome is reported as total metabolic equivalent task minutes per week (MET-minutes/week), calculated according to the International Physical Activity Questionnaire scoring protocol. Minimum value: 0 MET-minutes/week. There is no fixed maximum value. Higher values indicate higher levels of physical activity (better outcome).
Time frame
Baseline (single assessment visit)3
One-Minute Sit-to-Stand Test
Functional capacity assessed using the One-Minute Sit-to-Stand Test. The outcome is the total number of completed sit-to-stand repetitions performed in one minute. Minimum value: 0 repetitions. There is no fixed maximum value. Higher values indicate better functional capacity.
Time frame
Baseline4
Six-Minute Walk Test
Functional capacity assessed using the Six-Minute Walk Test. The outcome is the total distance walked in six minutes, measured in meters (m). Minimum value: 0 meters. There is no fixed maximum value. Higher values indicate better functional capacity.
Time frame
BaselineSponsors and contacts
Click on the lead sponsor to view all of their trials.
Hacettepe University
Lead sponsor
Munzur University
Sponsor institution
Source ClinicalTrials.gov