Distinguishing Participant Groups Using Autonomic Dysfunction

Diabetes Clinical Trial

Official title:

Distinguishing Participant Groups Using Autonomic Dysfunction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05199350
• Other study ID #: CS013
• Status: Completed
• Start date: November 17, 2021
• Est. completion date: July 29, 2022

Study information

• Verified date: August 2023
• Source: DyAnsys, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 175
• Est. completion date: July 29, 2022
• Est. primary completion date: July 29, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Autonomic Nervous System Diseases
• Diabetes
• Primary Dysautonomias

Intervention

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

Locations

Country	Name	City	State
India	Sri Rachandra Institute of HigherEducation And Research	Chennai	Tamil Nadu

Sponsors (1)

Lead Sponsor	Collaborator
DyAnsys, Inc.

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.