A study to validate breath analyzer device as a screening tool for diabetic & hepatic and renal metabolic disorders
Not Applicable
- Conditions
- Health Condition 1: E888- Other specified metabolic disorders
- Registration Number
- CTRI/2022/07/043835
- Lead Sponsor
- Humors Tech Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1.Apparently healthy individuals for phase I Diabetes, liver, renal and metabolic derangements for phase II of study.
2.Age group 18-60 years.
3.Completed 2 doses of COVID vaccination.
4.Willing to give written informed consent.
Exclusion Criteria
1.Pregnant and lactating females.
2.Known case of any chronic illness- Cancer, AIDS, COVID, Tuberculosis
3.History of any acute infection- respiratory tract infections.
4.Haemo-dynamically unstable critically ill intensive care unit patients.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Identification of bio-markers- Acetone <br/ ><br>Benzene,Toulene,Hydrogen, Carbon Monoxide,Ammonia,Ethanol <br/ ><br>Hydrogen Sulfide, Butane and <br/ ><br>Methane in breath sample and Development of Artificial Intelligence (AI) based affordable non-invasive device for accurate early screening of diabetes, liver, renal and metabolic function derangements by comparing values measured by breath analyzer device with blood levels of fasting, PPBS, LFT parameters and RFT parameters. <br/ ><br>Timepoint: Baseline <br/ ><br>
- Secondary Outcome Measures
Name Time Method Measurement of Total Cholesterol <br/ ><br>Triglycerides <br/ ><br>HDL <br/ ><br>VLDL <br/ ><br>LDL <br/ ><br>Cholesterol/ HDL Ratio <br/ ><br>LDL/HDL Ratio <br/ ><br>and compare with levels of critical compounds measured by breath analyzer device.Timepoint: 1 year