Distinguishing Patient Groups Using Autonomic Dysfunction

NCT04964921 | Unknown

• 1 other identifier: CS011
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

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)

Impaired Fasting Glucose Individuals

The group contains subjects with various stages of impaired fasting glucose tolerance levels and diabetes (with or without complications). All subjects will be considered in one group since the heart rate variability and vital signs are monitored in a single visit.

Other: Device: ANSiScope Plus

Interventions

Device: ANSiScope Plus OTHER

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

Impaired Fasting Glucose Individuals

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:

• Can provide informed consent.
• Age between 18 and 85 years old
• Body Mass Index: 25 ≤ BMI ≤ 40
• Hemoglobin A1c level: 7.5 ≤ HbA1c ≤ 9.5
• Individuals with pre-diabetes and diabetes Type II for at least 1 year (diagnosed by ADA criteria) and up to 20 years
• Advanced diabetic complications including neuropathy, nephropathy, retinopathy and other related complications
• Stable dose of medications for the previous 3 months
• Stable diet and lifestyle for the previous 3 months
• Stable medical status (Ex: no myocardial infarction, stroke, major surgery,

You may not qualify if:

• Unable to provide informed consent
• Chronic disease (e.g. HIV, Cushing syndrome, CKD, acromegaly, active hyperthyroidism etc.)
• Cancer and anticancer treatment in the last 5 years
• Psychiatric disorders (that in the eyes of the investigator should exclude the participant)
• Any disorder, which in the investigator's opinion might jeopardize subject's safety or compliance with the protocol
• Organ (kidney, pancreas, liver) transplant recipients
• Pregnancy or lactation
• Positive drug screen (opiates, methadone, cocaine, amphetamines, cannabinoids, barbiturates, benzodiazepines, tricyclic antidepressants and alcohol)
• Alcoholics or Smokers
• Positive screen on HBsAg, anti-HCV or anti-HIV ½
• History of diabetic ketoacidosis or hyperosmolar coma
• Subjects with known coronary artery disease or coronary revascularisation
• Subjects with previous history of cerebrovascular accident
• Subjects with known proliferative retinopathy or previous laser treatment for diabetic retinopathy
• Subjects with life-threatening conditions including malignancy

Sponsors & Collaborators

• DyAnsys, Inc.: lead

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

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

Study Officials

• Dr. Bathula Sridhar, MD,DM (Endo)

  Samraksha Diabetes, Thyroid, Endocrine Superspecialty Hospital and Research Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Murugesh K

CONTACT

+91-9840967384; k.murugesh@dyansys.com

Study Design

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

Study Record Dates

• First Submitted: July 3, 2021
• First Posted: July 16, 2021
• Study Start: December 1, 2021
• Primary Completion: February 1, 2022
• Study Completion: February 1, 2022
• Last Updated: November 3, 2021

Record last verified: 2021-11