Status:
COMPLETED
Distinguishing Participant Groups Using Autonomic Dysfunction
Lead Sponsor:
DyAnsys, Inc.
Conditions:
Diabetes
Eligibility:
All Genders
18-85 years
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. Thei...
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
November 17 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 29 2022
Estimated Enrollment :
175 Patients enrolled
Trial Details
Trial ID
NCT05199350
Start Date
November 17 2021
End Date
July 29 2022
Last Update
October 10 2023
Active Locations (1)
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1
Sri Rachandra Institute of HigherEducation And Research
Chennai, Tamil Nadu, India, 600116