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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Heart Rate Variability
研究概览
简要总结
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.
详细描述
Type 2 Diabetes Mellitus (T2DM) is a chronic metabolic disease characterized by insulin resistance and persistent hyperglycemia. Beyond disturbances in glucose metabolism, T2DM has profound effects on the central nervous system, autonomic nervous system, cardiovascular function, cognition, and mental health. Previous studies have demonstrated that individuals with T2DM have an increased risk of cognitive decline, cardiac autonomic neuropathy, reduced functional capacity, and psychological disorders such as depression and anxiety. Although electroencephalography (EEG) and heart rate variability (HRV) have independently been used to evaluate neural and autonomic dysfunction in T2DM, few studies have investigated these parameters simultaneously within the framework of the brain-heart axis.
The brain-heart axis describes the bidirectional interaction between cortical neural activity and autonomic cardiovascular regulation. Metabolic abnormalities associated with T2DM may alter cortical electrical activity, impair autonomic balance, and consequently influence cognitive performance, physical function, and psychological well-being. A comprehensive evaluation integrating these multidimensional outcomes may improve understanding of the systemic consequences of T2DM and identify potential biomarkers for early neurocardiac dysfunction.
The primary objective of this cross-sectional study is to investigate the relationships between metabolic status and brain-heart axis function in adults with T2DM. Specifically, the study will evaluate whether metabolic abnormalities are associated with alterations in EEG-derived brain activity and HRV-derived autonomic function and whether these neurophysiological changes are related to functional capacity, cognitive performance, physical activity level, and mental health.
Approximately 50 adults aged 40-65 years with a confirmed diagnosis of T2DM will be recruited from participating clinical centers. Eligible participants must be able to complete all study assessments and provide written informed consent. Individuals with neurological, psychiatric, orthopedic, or other severe systemic disorders that may interfere with study assessments, recent surgery, or cognitive impairment preventing completion of evaluations will be excluded.
Demographic and clinical characteristics will be collected from medical records, including age, medication use, medical history, HbA1c, fasting blood glucose, lipid profile, C-reactive protein, erythrocyte sedimentation rate, and other routine clinical parameters. No invasive procedures will be performed specifically for this study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
结局指标
主要结局
Heart Rate Variability
时间窗: Baseline (single assessment visit)
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.
Delta Band Power
时间窗: Baseline
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.
Theta Band Power
时间窗: Baseline
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.
Alpha Band Power
时间窗: Baseline
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.
Beta Band Power
时间窗: Baseline
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.
Frontal Alpha Asymmetry
时间窗: Baseline
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.
Functional Connectivity
时间窗: Baseline
Resting electroencephalography (EEG) assessment of functional connectivity between cortical regions using predefined EEG connectivity metrics.
次要结局
- 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)
- Anxiety Symptoms (DASS-21 Anxiety)(Baseline)
- Stress Symptoms (DASS-21 Stress)(Baseline)
- Anxiety Symptoms (HADS-A)(Baseline)
- Depression Symptoms (HADS-D)(Baseline)
- HbA1c(Baseline)
- Fasting Blood Glucose(Baseline)
- High-Density Lipoprotein Cholesterol (HDL)(Baseline)
- Low-Density Lipoprotein Cholesterol (LDL)(Baseline)
- Total Cholesterol(Baseline)
- Triglycerides(Baseline)
- C-Reactive Protein(Baseline)
- Erythrocyte Sedimentation Rate(Baseline)