Distinguishing Participant Groups Using Autonomic Dysfunction

Sponsor
DyAnsys, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05199350
Collaborator
(none)
175
1
7.3
23.9

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
175 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Distinguishing Participant Groups Using Autonomic Dysfunction
Actual Study Start Date :
Mar 23, 2022
Anticipated Primary Completion Date :
Nov 1, 2022
Anticipated Study Completion Date :
Nov 1, 2022

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Determination of autonomic dysfunction by subject [The measurement will happen in a single visit i.e 1 day.]

    The ANSiScope Plus will be used to determine the BB (beat to beat) score through heart rate variability measurements.

Secondary Outcome Measures

  1. Establish the absence of any relationship of autonomic dysfunction (AD) to any other vital signs parameters. [The measurement will happen in a single visit i.e 1 day.]

    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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sri Rachandra Institute of HigherEducation And Research Chennai Tamil Nadu India 600116

Sponsors and Collaborators

  • 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
DyAnsys, Inc.
ClinicalTrials.gov Identifier:
NCT05199350
Other Study ID Numbers:
  • CS013
First Posted:
Jan 20, 2022
Last Update Posted:
Jun 22, 2022
Last Verified:
Jan 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by DyAnsys, Inc.
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 22, 2022