Distinguishing Participant Groups Using Autonomic Dysfunction
Condition: Diabetes
MeSH terms: Autonomic Nervous System Diseases; Primary Dysautonomias
Study type: Observational

Summary: 
      A study population with impaired fasting glucose levels, impaired glucose tolerance levels
      and diabetes (with or without complications) along with healthy patients will be chosen as
      participants. Their vital signs and their ECG (electrocardiograph) will be recorded during
      their only visit. Data analysis will be performed using the vital signs parameters. The RR
      intervals from the ECG will be analyzed by 5 different techniques to determine the best
      technique that stratifies the subjects the most accurately.
    

Detailed description: 
      The Autonomic Nervous System (ANS) is a fundamental part of the nervous system in the body.
      And yet, there is no technique to test or measure the health and functioning of a person's
      autonomic nervous system.This type of study will determine the most accurate methodology to
      test the autonomic nervous system through heart rate variability (HRV) monitoring and gain
      vital information to distinguish patient groups in the diabetic population.

      There is no gold standard for measuring autonomic dysfunction. Currently the method of power
      spectral analysis is finding very wide usage. It Is known that power spectral analysis does
      not discriminate the two subsystems of the ANS well. There are other beat to beat
      methodologies that have not yet gained traction. The reason for conducting this trial is to
      take a group of subjects in various stages of impaired fasting glucose, impaired glucose
      tolerance and diabetes (with and without complications) and determine which methodology
      stratifies these subjects most accurately.

      Our study aims to introduce a new measurement method named the 'Beat to Beat' (BB) method for
      gauging autonomic dysfunction in patients. The investigators hope to observe that the average
      beat to beat method (BB) score could help discriminating diabetic patients into the following
      five distinct groups from the pilot study:

        1. Normal Glucose Tolerance (NGT) is defined as a plasma glucose concentration i.e < 140
           mg/dl.

        2. Impaired Fasting Glucose (IFG) is defined by an elevated fasting plasma glucose (FPG)
           concentration i.e ≥ 100 and < 126 mg/dl.

        3. Impaired Glucose Tolerance (IGT) is defined by an elevated post-prandial plasma glucose
           concentration i.e ≥140 and < 200 mg/dl.

        4. Presence of confirmed diabetes (HbA1c level > 6.4 %) without complications i.e no
           neuropathy, no retinopathy, no nephropathy etc.

        5. Presence of confirmed diabetes (HbA1c level > 6.4 %) with at least one of the above
           complications.

      By showing that this measurement bears no relationship to the other four vital signs
      parameters (heart rate, blood oxygenation, blood pressure, body temperature), it will prove
      the necessity of this measurement in addition to the four vital signs for distinguishing
      patient groups among the diabetic population.
    

Intervention name(s): Device Name: ANSiscope
Intervention type(s): Other
Intervention description(s): Heart rate variability measurement and vital signs monitoring will be performed on all subjects.
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Adults of either sex with various stages of impaired fasting glucose tolerance levels and
        diabetes (with or without complications) will be considered as study population.
      
Keywords: Impaired Fasting Glucose; Autonomic Dysfunction Measurement; Heart Rate Variability; Vital Signs Monitoring