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Analysis of Microalbuminuria and Markers of Inflammation and Oxidative Stress in Adolescents of Different Ethnic Backgrounds (IM)

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ClinicalTrials.gov Identifier: NCT00616707
Recruitment Status : Completed
First Posted : February 15, 2008
Last Update Posted : May 30, 2017
Sponsor:
Collaborator:
Children's Miracle Network
Information provided by (Responsible Party):
University of California, Davis

Brief Summary:
The purpose of this study is to determine if there are signs of inflammation in one's blood and urine and to find out if one's body size or ethnicity has an effect on these substances.

Condition or disease
Inflammation

Study Type : Observational
Actual Enrollment : 68 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Analysis of Microalbuminuria and Markers of Inflammation and Oxidative Stress in Adolescents of Different Ethnic Backgrounds
Study Start Date : August 2006
Actual Primary Completion Date : October 2009
Actual Study Completion Date : October 2009



Primary Outcome Measures :
  1. To compare plasma levels of inflammatory markers and urinary biomarkers of oxidative stress in adolescents of Hispanic, African-American and Caucasian ethnicity [ Time Frame: at the end of study ]

Secondary Outcome Measures :
  1. To determine if there is an independent correlation between these markers and urinary microalbumin excretion [ Time Frame: at the end of study ]

Biospecimen Retention:   Samples Without DNA
Aliquots from the citrate vial & Serum seperator vial are being retained


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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
pediatric out-patient at UCDavis Medical Center clinic
Criteria

Inclusion Criteria:

  • Adolescents between 12 to 18 years old
  • Hispanic, African American or Caucasian ethnicity
  • Have a Body Mass Index (BMI) between the 5th and 85th percentile or greater than the 95th percentile
  • Must currently be attending a UC Davis Pediatric clinic

Exclusion Criteria:

  • Chronic liver or kidney disease, known Diabetes or other chronic illnesses (such as Sickle Cell Disease or Cystic Fibrosis)
  • Subjects can NOT be acutely febrile, smoke, chronically use prescription medications or oral contraceptive pills.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00616707


Locations
United States, California
UC Davis Medical Center
Sacramento, California, United States, 95817
Sponsors and Collaborators
University of California, Davis
Children's Miracle Network
Investigators
Principal Investigator: Lavjay Butani, M.D. University of California, Davis

Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT00616707     History of Changes
Other Study ID Numbers: 200614513
First Posted: February 15, 2008    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 2017

Keywords provided by University of California, Davis:
Inflammation
Oxidative Stress
Microalbuminuria

Additional relevant MeSH terms:
Inflammation
Pathologic Processes