Normal Values of Oxidative Stress, Taurine, and Related Markers

NCT02649777 | Completed

• 2 other identifiers: 15-2091UL1TR001082
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Oxidative Stress

Keywords

oxidative stress

Outcome Measures

Primary Outcomes (2)

• Oxidative stress marker: TBARS

  Single Draw for one-time analysis

  Time 0

• Metabolite antioxidant: Taurine

  Single Draw for one-time analysis

  Time 0

Secondary Outcomes (10)

• Inflammation marker: Supper oxide dismutase (SOD)

  Time 0

• Inflammation marker: TGFβ

  Time 0

• Inflammation marker: myeloperoxidase

  time 0

• Metabolites: S-adenosylmethionine and S-adenosylhomocysteine

  Time 0

• Vascular function: Thromboxane B2 metabolites

  Time 0

Eligibility Criteria

• Age: 8 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy Individuals older than 8 years and less than 50 years

You may qualify if:

• Age: Over 8 years old and less than 50 years

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

Study Officials

• Johan LK Van Hove, MD, PhD, MBA

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2016
• First Posted: January 7, 2016
• Study Start: January 1, 2016
• Primary Completion: June 1, 2016
• Study Completion: December 1, 2017
• Last Updated: January 19, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)