Analysis of Microalbuminuria and Markers of Inflammation and Oxidative Stress in Adolescents of Different Ethnic Backgrounds - Full Text View

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

This study is currently recruiting participants.

Verified by University of California, Davis, February 2008

First Received: February 4, 2008 Last Updated: February 14, 2008 History of Changes

Sponsors and Collaborators:	University of California, Davis Children's Miracle Network
Information provided by:	University of California, Davis
ClinicalTrials.gov Identifier:	NCT00616707

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

U.S. FDA Resources

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

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

Biospecimen Description:

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

Estimated Enrollment:	300
Study Start Date:	August 2006
Estimated Study Completion Date:	August 2008
Estimated Primary Completion Date:	August 2008 (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

Contacts

Contact: J. Gularte

(916) 734-7222

Locations

United States, California
UC Davis Medical Center	Recruiting
Sacramento, California, United States, 95817
Principal Investigator: Lavjay Butani, M.D.

Sponsors and Collaborators

University of California, Davis

Children's Miracle Network

Investigators

Principal Investigator:

Lavjay Butani, M.D.

University of California, Davis

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	University of California, Davis Medical Center ( Lavjay Butani M.D./ Associate Professor & Section Chief of Pediatric Nephrology )
Study ID Numbers:	200614513-2
Study First Received:	February 4, 2008
Last Updated:	February 14, 2008
ClinicalTrials.gov Identifier:	NCT00616707 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, Davis:

Inflammation
Oxidative Stress
Microalbuminuria

Study placed in the following topic categories:

Stress
Inflammation

Additional relevant MeSH terms:

Pathologic Processes
Inflammation

ClinicalTrials.gov processed this record on May 07, 2009