- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03512535
Method Validation for New Nitrogen/Sulfur Species Analysis Techniques
Plasma redox status is well known to alter with age but previously differences have only been reported for two specific redox couples; reduced and oxidized cysteine and reduced and oxidized glutathione. (Jones DP, Rejuvenation Res. 2006) The overall aim of this project is to develop new methods to determine how other Reactive Nitrogen and Sulfur species, such as free and protein-bound thiols (organic compounds that contain a Sulfhydryl group, -SH) and Hydrogen Sulfide (H2S) change with age and gender in a medium-sized cohort of healthy individuals (n=100 of either sex; age 18-70).
Our group has recently developed a novel analytical platform to measure thiol-containing compounds in biological samples that is based on the reaction with the thiol-alkylating agent N-ethylmaleimide (NEM). We have used this chemical for years as stabilisation agent in other analyses to quantify Nitric Oxide metabolites.(Feelisch et al, FASEB 2002 and Levett et al, Sci Rep 2011) We now wish to develop a similar method to measure thiol containing compounds using a novel rapid LC-MS/MS based technology for screening large numbers of individuals.
The project will therefore have 2 stages:
- Initial method development will require occasional use of whole blood, plasma and red blood cells to establishing optimal conditions. E.g. to compare heparin and EDTA as anticoagulants to serum; investigate effects of temperature and pH; identify optimal concentration of derivatisation/reduction agents and optimal reaction times.
- We then aim to establish the normal distribution of these novel compounds across healthy individuals of different gender and varying ages.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiesteder
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Hampshire
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Southampton, Hampshire, Det Forenede Kongerige, SO16 6YD
- University of Southampton
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Aged 18 years or above
- Currently healthy (i.e. no inter-current illness/infection)
- Capacity and ability to give written informed consent
Exclusion Criteria:
- Current or previous smoker
- Other medical co-morbidity (e.g. hypertension, diabetes, asthma, COPD, cardiovascular disease, current or previous malignant disease etc.)
- Surgery within previous 28 days
- Excessive alcohol intake (i.e above UK's recommended intake limit of 14 units per week).
- Pregnant or currently breast-feeding
- On current medication
- Taken vitamins / minerals / herbal remedies within previous 28 days
- Difficult venous access
- Needle phobia
- Participating in another similar/conflicting research study already
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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Stage 1
Samples from up to 20 participants will be used to finalise the analytical methods
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Stage 2
Samples from up to 200 participants will be used to then validate the normal ranges of these markers across different age ranges in both genders
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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Concentration of reactive (nitrogen or sulfur containing) species
Tidsramme: Baseline
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Baseline
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studiestol: Martin Feelisch, PhD, University of Southampton
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 31426
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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