NCT00616707

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2006

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

February 4, 2008

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 15, 2008

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

May 30, 2017

Status Verified

May 1, 2017

Enrollment Period

3.2 years

First QC Date

February 4, 2008

Last Update Submit

May 25, 2017

Conditions

Inflammation

Keywords

InflammationOxidative StressMicroalbuminuria

Outcome Measures

Primary Outcomes (1)

  • To compare plasma levels of inflammatory markers and urinary biomarkers of oxidative stress in adolescents of Hispanic, African-American and Caucasian ethnicity

    at the end of study

Secondary Outcomes (1)

  • To determine if there is an independent correlation between these markers and urinary microalbumin excretion

    at the end of study

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

pediatric out-patient at UCDavis Medical Center clinic

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UC Davis Medical Center

Sacramento, California, 95817, United States

Location

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

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

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Lavjay Butani, M.D.

    University of California, Davis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2008

First Posted

February 15, 2008

Study Start

August 1, 2006

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

May 30, 2017

Record last verified: 2017-05

Locations

US(1)