DiabetesNCT05199350
Distinguishing Participant Groups Using Autonomic Dysfunction
An observational study of Diabetes, run by DyAnsys, Inc. at 1 site in India.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- Device Name: ANSiscope
- How many people
- 175 participants
- Where
- 1 siteIndia
- Study dates
- 17 Nov 2021to 29 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
India1 site
Sri Rachandra Institute of HigherEducation And Research
Chennai, Tamil Nadu, 600116
About this study
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.
Read the 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:
- Normal Glucose Tolerance (NGT) is defined as a plasma glucose concentration i.e < 140 mg/dl.
- Impaired Fasting Glucose (IFG) is defined by an elevated fasting plasma glucose (FPG) concentration i.e ≥ 100 and < 126 mg/dl.
- Impaired Glucose Tolerance (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.
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.
- Conditions
- Diabetes
- Being tested
- Device Name: ANSiscope
- Keywords
- Impaired Fasting Glucose, Autonomic Dysfunction Measurement, Heart Rate Variability, Vital Signs Monitoring
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device Name: ANSiscopeOther
Heart rate variability measurement and vital signs monitoring will be performed on all subjects.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Device Name: ANSiscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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)
Measured: The measurement will happen in a single visit i.e 1 day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start17 Nov 2021
- Primary completion29 Jul 2022
- Study completion29 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- DyAnsys, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. Mathangi Dr D.C, Prof &Head M.SC., Phd, Principal investigator, Sri Rachandra Institute of HigherEducation And Research hospitalpriscilla Dr johnson, MBBS,MD, DNB, PhD, Study chair, Sri Rachandra Institute of HigherEducation And Research hospitalshriram Dr Mahadevan, Principal investigator, Sri Rachandra Institute of HigherEducation And Research hospitalDivyalakshmi Dr Divyalakshmi k, MBBS,MD, Study director, Sri Rachandra Institute of HigherEducation And Research hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05199350
- Sponsor's protocol ID
- CS013
- Status last verified
- Aug 2023
- First submitted
- 6 Jan 2022
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Distinguishing Participant Groups Using Autonomic Dysfunction
- ClinicalTrials.gov ID
- NCT05199350
- Acronym / sponsor ID
- CS013
- Conditions
- Diabetes
- Keywords
- Impaired Fasting Glucose, Autonomic Dysfunction Measurement, Heart Rate Variability, Vital Signs Monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- DyAnsys, Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Nov 2021 (actual)
- Primary completion
- 29 Jul 2022 (actual)
- Study completion
- 29 Jul 2022 (actual)
- First posted
- 20 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- Normal Glucose Tolerance (NGT) is defined as a plasma glucose concentration i.e < 140 mg/dl.
- Impaired Fasting Glucose (IFG) is defined by an elevated fasting plasma glucose (FPG) concentration i.e ≥ 100 and < 126 mg/dl.
- Impaired Glucose Tolerance (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.
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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Population including people with NGT, IFG and IGT and diabetes. | – | Other: Device Name: ANSiscopeNormal 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Device Name: ANSiscopeHeart rate variability measurement and vital signs monitoring will be performed on all subjects. | Other | Population including people with NGT, IFG and IGT and diabetes. |
Primary outcome
Determination of autonomic dysfunction by subject
Time frame: 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.
1 secondary outcome
Establish the absence of any relationship of autonomic dysfunction (AD) to any other vital signs parameters.
Time frame: The measurement will happen in a single visit i.e 1 day.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Mathangi Dr D.C, Prof &Head M.SC., Phd principal investigator
Sri Rachandra Institute of HigherEducation And Research hospital
priscilla Dr johnson, MBBS,MD, DNB, PhD study chair
Sri Rachandra Institute of HigherEducation And Research hospital
shriram Dr Mahadevan principal investigator
Sri Rachandra Institute of HigherEducation And Research hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes, run by DyAnsys, Inc. at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of autonomic dysfunction by subject (time frame: The measurement will happen in a single visit i.e 1 day.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2023.