Brain-Heart Axis in Type 2 Diabetes Mellitus

NCT07757308 | Recruiting

• 1 other identifier: 2026/8-41
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 2 Diabetes Mellitus (T2DM)

Keywords

Type 2 Diabetes Mellitus; Electroencephalography (EEG); Heart Rate Variability; Brain-Heart Axis; Functional Capacity

Outcome Measures

Primary Outcomes (7)

• 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

• 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

Secondary Outcomes (17)

• 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

Study Arms (1)

Adults with Type 2 Diabetes Mellitus

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.

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Munzur University Faculty of Health Sciences

Tunceli, Turkey (Türkiye)

RECRUITING

Related Publications (1)

• 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.

  PMID: 36081005 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Ceyhun TOPCUOGLU, Dr.

CONTACT

+90 535 653 51 37; ceyhuntopcuoglu1@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: August 2, 2026
• First Posted: August 11, 2026
• Study Start: June 25, 2026
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: August 11, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)