InflammationIMNCT00616707
Analysis of Microalbuminuria and Markers of Inflammation and Oxidative Stress in Adolescents of Different Ethnic Backgrounds
An observational study of Inflammation, run by University of California, Davis at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Inflammation
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2006to Oct 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: pediatric out-patient at UCDavis Medical Center clinic
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
UC Davis Medical Center
Sacramento, California, 95817
About this study
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.
- Conditions
- Inflammation
- Keywords
- Inflammation, Oxidative Stress, Microalbuminuria
- Medical subject headings
- Inflammation
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare plasma levels of inflammatory markers and urinary biomarkers of oxidative stress in adolescents of Hispanic, African-American and Caucasian ethnicity
Measured: at the end of study
Secondary outcomes (1)
To determine if there is an independent correlation between these markers and urinary microalbumin excretion
Measured: at the end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2008 (estimated)
- Study startAug 2006
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InflammationStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Miracle Network
- Responsible party
- Sponsor
- Investigators
- Lavjay Butani, M.D., Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00616707
- Sponsor's protocol ID
- 200614513
- Acronym
- IM
- Status last verified
- May 2017
- First submitted
- 4 Feb 2008
- Last updated
- 30 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Microalbuminuria and Markers of Inflammation and Oxidative Stress in Adolescents of Different Ethnic Backgrounds
- ClinicalTrials.gov ID
- NCT00616707
- Acronym / sponsor ID
- IM / 200614513
- Conditions
- Inflammation
- Keywords
- Inflammation, Oxidative Stress, Microalbuminuria
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- Children's Miracle Network
- Study start
- Aug 2006
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 15 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- pediatric out-patient at UCDavis Medical Center clinic
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
To determine if there is an independent correlation between these markers and urinary microalbumin excretion
Time frame: at the end of study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lavjay Butani, M.D. principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammation, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2017.