Distinguishing Participant Groups Using Autonomic Dysfunction

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.

Study Overview

• Status: Completed
• Conditions: Diabetes
• Intervention / Treatment: Other: Device Name: ANSiscope

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.

• Study Type: Observational
• Enrollment (Actual): 175

Contacts and Locations

Study Locations

• India
  • Tamil Nadu
    • Chennai, Tamil Nadu, India, 600116
      • Sri Rachandra Institute of HigherEducation And Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• 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.

Description

Inclusion Criteria:

1. Able to provide informed consent
2. Age between 18 to 85
3. Body Mass Index (BMI) between 25 and 40 kg/m2
4. Individuals with normal glucose levels, pre-diabetes and diabetes Type 2 for at least 1 year (diagnosed by ADA criteria) and up to 20 years
5. Stable dose of meds for 3 months
6. Stable diet and lifestyle for 3 months
7. Medical history without clinically significant abnormalities

Exclusion Criteria:

1. Have a disorder that would impede performing the HRV measurement procedure (i.e., abnormal cardiac rhythm, heart disease, including coronary artery disease, angina, and arrhythmia, cardiac pacemaker, stroke, panic attack, cognitive impairment, renal failure)
2. Chronic disease (e.g. HIV, Cushing syndrome, CKD, acromegaly, active hyperthyroidism etc.)
3. Cancer and anticancer treatment in the last 5 years
4. Pregnancy or lactation
5. Subjects with major physical disability
6. Subjects with previous history of cerebrovascular accident
7. Any disorder, which in the investigator's opinion might jeo

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Population including people with NGT, IFG and IGT and diabetes.; Normal Glucose Tolerance (NGT) is defined as a plasma glucose concentration i.e < 140 mg/dl. IFG is defined by an elevated fasting plasma glucose (FPG) concentration i.e ≥ 100 and < 126 mg/dl. IGT is defined by an elevated post-prandial plasma glucose concentration i.e ≥140 and < 200 mg/dl. Presence of confirmed diabetes (HbA1c level > 6.4 %) without complications i.e no neuropathy, no retinopathy, no nephropathy etc. Presence of confirmed diabetes (HbA1c level > 6.4 %) with at least one of the above complications.

Other: Device Name: ANSiscope; Heart rate variability measurement and vital signs monitoring will be performed on all subjects.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determination of autonomic dysfunction by subject	The ANSiScope Plus will be used to determine the BB (beat to beat) score through heart rate variability measurements.	The measurement will happen in a single visit i.e 1 day.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Establish the absence of any relationship of autonomic dysfunction (AD) to any other vital signs parameters.	Investigate the importance of measuring the autonomic dysfunction in the presence of other vital signs measurements (heart rate, body temperature, blood oxygenation and blood pressure)	The measurement will happen in a single visit i.e 1 day.

Collaborators and Investigators

• Sponsor: DyAnsys, Inc.
• Investigators: Principal Investigator: Dr. Mathangi Dr D.C, Prof &Head M.SC., Phd, Sri Rachandra Institute of HigherEducation And Research hospital; Study Chair: priscilla Dr johnson, MBBS,MD, DNB, PhD, Sri Rachandra Institute of HigherEducation And Research hospital; Principal Investigator: shriram Dr Mahadevan, Sri Rachandra Institute of HigherEducation And Research hospital; Study Director: Divyalakshmi Dr Divyalakshmi k, MBBS,MD, Sri Rachandra Institute of HigherEducation And Research hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2021
• Primary Completion (Actual): July 29, 2022
• Study Completion (Actual): July 29, 2022

Study Registration Dates

• First Submitted: January 6, 2022
• First Submitted That Met QC Criteria: January 6, 2022
• First Posted (Actual): January 20, 2022

Study Record Updates

• Last Update Posted (Estimated): October 10, 2023
• Last Update Submitted That Met QC Criteria: October 9, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Heart Rate Variability; Impaired Fasting Glucose; Autonomic Dysfunction Measurement; Vital Signs Monitoring
• Additional Relevant MeSH Terms: Nervous System Diseases; Primary Dysautonomias; Autonomic Nervous System Diseases
• Other Study ID Numbers: CS013

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No