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External Nitric Oxide Measurement Through SNO Degradation

NCT ID: NCT04903535

Last Updated: 2024-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-10

Study Completion Date

2025-12-30

Brief Summary

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In this study, we aim to explore the feasibility of a novel, noninvasive SNO assay to acquire physiological SNO quantification from various parts of the human body and test this new method of analysis. This study aims to help with the currently cumbersome and invasive procedures used to measure SNOs in the body. The proposed activities do not unnecessarily duplicate previous experiments.

Detailed Description

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S-nitrosylation is the covalent attachment of a nitric oxide group to cystine thiol within a protein to form an S-nitrosothiol (SNO); it has diverse regulatory roles in all mammalian cells and thus operates as a fundamental mechanism for cellular signaling and accounts for a large part of nitric oxide activity. Though SNOs are relevant to many biological disciplines like neuronal, muscular, respiratory, and cardiovascular biology, currently there is no way to measure SNOs that is both easy to use in a clinical setting and accurate in detecting low concentrations; detection is challenging due to the labile nature of the molecules. Low or high concentrations of these molecules could be vital indicators of incoming dangerous issues in the body. A system to easily and accurately measure SNOs could prove useful in preventative treatments. Ultra Violet (UV) light can break SNOs and can be used to measure nitric oxide release, but this method is not fully developed and further research is needed on the potential effect for UV to measure nitric oxide release.

Conditions

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Healthy Unconscious

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Healthy Volunteers
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Healthy Volunteers

Study will enroll to test the assay

Group Type EXPERIMENTAL

Alonefire SV003 10W 365nm UV Flashlight

Intervention Type DEVICE

Investigator will use a Nitric Oxide Analyzer while attached to a small suction port on the subject's ear lobe to be tested for Nitric Oxide. After getting the baseline assay, the investigator will shine a low-intensity UV Flashlight (Alonefire SV003 10W 365nm UV Flashlight) at the ear lobe for 10 seconds, repeated three times at 20 second intervals, to determine if there is photobleaching. Then the assay will then be performed on the opposite ear lobe. Fifteen minutes after the third UV flashlight exposure, the investigator will collect air from the subject's ear during photolysis into a 20mL glass syringe (once from each ear). Fifteen minutes after the third UV flashlight exposure, the investigator will collect air from the subject's ear during photolysis into a 20mL glass syringe (once from each ear). The subject and the investigator will wear UV goggles during the experiment.

Interventions

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Alonefire SV003 10W 365nm UV Flashlight

Investigator will use a Nitric Oxide Analyzer while attached to a small suction port on the subject's ear lobe to be tested for Nitric Oxide. After getting the baseline assay, the investigator will shine a low-intensity UV Flashlight (Alonefire SV003 10W 365nm UV Flashlight) at the ear lobe for 10 seconds, repeated three times at 20 second intervals, to determine if there is photobleaching. Then the assay will then be performed on the opposite ear lobe. Fifteen minutes after the third UV flashlight exposure, the investigator will collect air from the subject's ear during photolysis into a 20mL glass syringe (once from each ear). Fifteen minutes after the third UV flashlight exposure, the investigator will collect air from the subject's ear during photolysis into a 20mL glass syringe (once from each ear). The subject and the investigator will wear UV goggles during the experiment.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Adult males or females age ≥ 1 day and ≤ 75 years at time of enrollment

Exclusion Criteria

* Subjects meeting the following criteria will be excluded:
* Smokers.
* Any chronic skin conditions.
* Pregnant.
* Subjects that are unable or unwilling to cooperate with specimen collection.
* Subjects with diagnosis of any medical condition that in the investigator's opinion would make them unsuitable for study participation.
* (for subjects ≥ 18) Subjects that lack the capacity to consent for themselves.
Minimum Eligible Age

1 Day

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Indiana University

OTHER

Sponsor Role lead

Responsible Party

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Nadzeya V Marozkina

Assistant Research Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nadzeya Marozkina, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University School of Medicine

Locations

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Riley Hospital for Children

Indianapolis, Indiana, United States

Site Status

Wells Center for Pediatric Research

Indianapolis, Indiana, United States

Site Status

Countries

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United States

References

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Marozkina NV, Gaston B. Nitrogen chemistry and lung physiology. Annu Rev Physiol. 2015;77:431-52. doi: 10.1146/annurev-physiol-021113-170352.

Reference Type BACKGROUND
PMID: 25668023 (View on PubMed)

Straub AC, Lohman AW, Billaud M, Johnstone SR, Dwyer ST, Lee MY, Bortz PS, Best AK, Columbus L, Gaston B, Isakson BE. Endothelial cell expression of haemoglobin alpha regulates nitric oxide signalling. Nature. 2012 Nov 15;491(7424):473-7. doi: 10.1038/nature11626. Epub 2012 Oct 31.

Reference Type BACKGROUND
PMID: 23123858 (View on PubMed)

Marozkina NV, Gaston B. S-Nitrosylation signaling regulates cellular protein interactions. Biochim Biophys Acta. 2012 Jun;1820(6):722-9. doi: 10.1016/j.bbagen.2011.06.017. Epub 2011 Jun 24.

Reference Type BACKGROUND
PMID: 21745537 (View on PubMed)

Palmer LA, Gaston B. S-nitrosothiol assays that avoid the use of iodine. Methods Enzymol. 2008;440:157-76. doi: 10.1016/S0076-6879(07)00809-9.

Reference Type BACKGROUND
PMID: 18423216 (View on PubMed)

Other Identifiers

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10839

Identifier Type: -

Identifier Source: org_study_id