Distinguishing Participant Groups Using Autonomic Dysfunction

NCT05199350 | Completed

• 1 other identifier: CS013
• Study Type: observational
• Target: 175
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes

Keywords

Impaired Fasting Glucose; Autonomic Dysfunction Measurement; Heart Rate Variability; Vital Signs Monitoring

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (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.

Study Arms (1)

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

Interventions

Device Name: ANSiscope OTHER

Heart rate variability measurement and vital signs monitoring will be performed on all subjects.

Population including people with NGT, IFG and IGT and diabetes.

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Able to provide informed consent
• Age between 18 to 85
• Body Mass Index (BMI) between 25 and 40 kg/m2
• 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
• Stable dose of meds for 3 months
• Stable diet and lifestyle for 3 months
• Medical history without clinically significant abnormalities

You may not qualify if:

• 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)
• Chronic disease (e.g. HIV, Cushing syndrome, CKD, acromegaly, active hyperthyroidism etc.)
• Cancer and anticancer treatment in the last 5 years
• Pregnancy or lactation
• Subjects with major physical disability
• Subjects with previous history of cerebrovascular accident
• Any disorder, which in the investigator's opinion might jeo

Sponsors & Collaborators

• DyAnsys, Inc.: lead

Study Sites (1)

Sri Rachandra Institute of HigherEducation And Research

Chennai, Tamil Nadu, 600116, India

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Dr. Mathangi Dr D.C, Prof &Head M.SC., Phd

  Sri Rachandra Institute of HigherEducation And Research hospital

  PRINCIPAL INVESTIGATOR

• priscilla Dr johnson, MBBS,MD, DNB, PhD

  Sri Rachandra Institute of HigherEducation And Research hospital

  STUDY CHAIR

• shriram Dr Mahadevan

  Sri Rachandra Institute of HigherEducation And Research hospital

  PRINCIPAL INVESTIGATOR

• Divyalakshmi Dr Divyalakshmi k, MBBS,MD

  Sri Rachandra Institute of HigherEducation And Research hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2022
• First Posted: January 20, 2022
• Study Start: November 17, 2021
• Primary Completion: July 29, 2022
• Study Completion: July 29, 2022
• Last Updated: October 10, 2023

Record last verified: 2023-08

Locations

IN (1)