Overview

This trial is active, not recruiting.

Condition oxidative stress
Sponsor University of Colorado, Denver
Start date January 2016
End date June 2016
Trial size 25 participants
Trial identifier NCT02649777, 15-2091, UL1TR001082

Summary

The role of oxidative stress in disease pathology is increasingly recognized. At present, the development of biomarkers of this state is in its infancy and the availability of clinically validated assays is lacking. This study will better determine normal values for specific biomarkers of oxidative stress. It will also investigate normal values of taurine, a natural occurring oxidative stress protectant. A primary and specific application of this data is for the evaluation of oxidative stress, levels of the natural protectant taurine, and of associated inflammation in the context of cystathionine β-synthase (ClinicalTrials.gov study: Oxidative Stress Markers in Inherited Homocystinuria and the Impact of Taurine).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective

Primary Outcomes

Measure
Oxidative stress marker: TBARS
time frame: Time 0
Metabolite antioxidant: Taurine
time frame: Time 0

Secondary Outcomes

Measure
Inflammation marker: Supper oxide dismutase (SOD)
time frame: Time 0
Inflammation marker: TGFβ
time frame: Time 0
Inflammation marker: myeloperoxidase
time frame: time 0
Metabolites: S-adenosylmethionine and S-adenosylhomocysteine
time frame: Time 0
Vascular function: Thromboxane B2 metabolites
time frame: Time 0
Oxidative stress: dityrosine
time frame: Time 0
Inflammation markers: IL1α, IL-1β, IL10, TNFα
time frame: Time 0
Inflammation markers: cytokines: IL1α, IL-1β IL-1ra, IL6, IL8, IL17, MCP-1,MIP-1, MIP1α, MIPβ
time frame: Time 0
Inflammation markers: cytokines: TNFα, IL4, IL10 and IL12
time frame: Time 0
Inflammation marker: high sensitivity CRP
time frame: Time 0

Eligibility Criteria

Male or female participants from 8 years up to 50 years old.

Inclusion Criteria: - Age: Over 8 years old and less than 50 years Exclusion Criteria: - Pregnancy: Females who are pregnant or lactating will be excluded from the study as the influence of pregnancy on the markers is not known nor is the impact of pregnancy on taurine known. - Antioxidant use: Individuals taking taurine, over the counter energy drinks containing taurine or other high dose antioxidants such as Vitamin C or E, coenzyme Q, carotenes, selenium will be excluded as such intake will likely impact laboratory results. - Inflammatory status: - Individuals who have a significant chronic illness or state that has a known or suspected marked inflammatory component or oxidative stress component will be excluded from the study as the illness will impact inflammatory markers. - Patients with an acute illness, which may impact inflammatory biomarkers, will be postponed for study entry until the acute illness is resolved. Entry into the study at a later day will be offered. The study visit will not be conducted within 3 weeks of the acute illness. - Smoking within the past 12 months will be excluded.

Additional Information

Official title Normal Values of Oxidative Stress, Taurine, and Related Markers
Principal investigator Johan LK Van Hove, MD, PhD, MBA
Description This study is a one-time collection of blood and urine samples in healthy individuals. Subjects have to be fasting for 3 hours prior to the blood sampling. A maximum of 7.5 mLs of blood (1 and 1/5 teaspoon) and a urine sample will be collected.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by University of Colorado, Denver.