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

This study has been completed.
Sponsor:
Collaborator:
Children's Miracle Network
Information provided by (Responsible Party):
Lavjay Butani, MD, University of California, Davis
ClinicalTrials.gov Identifier:
NCT00616707
First received: February 4, 2008
Last updated: November 22, 2012
Last verified: November 2012
  Purpose

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
Inflammation

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Analysis of Microalbuminuria and Markers of Inflammation and Oxidative Stress in Adolescents of Different Ethnic Backgrounds

Resource links provided by NLM:


Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine if there is an independent correlation between these markers and urinary microalbumin excretion [ Time Frame: at the end of study ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Aliquots from the citrate vial & Serum seperator vial are being retained


Enrollment: 68
Study Start Date: August 2006
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   12 Years to 18 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Lavjay Butani, MD, Associate Professor, University of California, Davis
ClinicalTrials.gov Identifier: NCT00616707     History of Changes
Other Study ID Numbers: 200614513-2
Study First Received: February 4, 2008
Last Updated: November 22, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Inflammation
Albuminuria
Pathologic Processes
Proteinuria
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on April 14, 2014