- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00320086
Microalbuminuria in Children With and Without Diabetes
Study Overview
Status
Conditions
Detailed Description
Diabetic nephropathy is a known cause of significant morbidity and mortality in adult patients with diabetes. Microalbuminuria (MA) is predictive of future diabetic nephropathy (DN) in adult patients with diabetes mellitus (DM). This link between MA levels and DN allows patients to receive timely interventions. The predictive value of MA for DN in children with DM, however, is not well established. Most studies looking at this association in children have only been forced to use adult MA values. Children, particularly adolescents, are known to have different normal values for 24-hour total protein excretion compared to adults and it may be that they also have different normal levels of MA. Little literature exists on normal levels of 24 hr MA in healthy children and in children with diabetes.
In this study, we seek to define the range of MA levels that falls between the 2.5 and 97.5 percentiles for children with and without DM. Once these values are established, we will have a foundation for further studies to define which, if any, MA values are predictive of DN in children. If we can establish a MA level which is predictive of DN in children, it will allow physicians to direct medical intervention at those most likely to benefit while protecting others from unnecessary medications, procedures, and risks.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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New Mexico
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Albuquerque, New Mexico, United States, 87131
- University of New Mexico
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Healthy children 6 to 18
- Diabetic children 6 to 18
Exclusion Criteria:
- kidney disease
- abnormal body temperature
- history of documented urinary tract infection
- metabolic disease other than diabetes mellitus
- circulatory disease
- liver disease
- strenuous exercise in prior 24 hours
- nocturnal enuresis
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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diabetes group
6 to 18 years old males and females, with confirmed diagnosis of Type I or Type II Diabetes with no history of: kidney disease, documented urinary tract infection, cardiovascular disease, liver disease, nocturnal enuresis, metabolic disease other that diabetes, abnormal body temperature at start of study visit, no strenuous exercise 24 hours prior to start of study visit.
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control group
6 to 18 years old males and females, with no history of: Type I or Type II Diabetes and/or other metabolic disease, kidney disease, documented urinary tract infection, cardiovascular disease, liver disease, nocturnal enuresis, abnormal body temperature at start of study visit, no strenuous exercise 24 hours prior to start of study visit.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of Subjects With Normal Urinary Protein Excretion in Healthy and Diabetic Children, Assessed Over 1 Day.
Time Frame: during hospitalization
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during hospitalization
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Aaron Jacobs, University of New Mexico- Pediatric department
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HRRC#04-250
- M01RR000997 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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