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NCT00320086 Clinical Trial

Microalbuminuria in Children With and Without Diabetes

Diabetes Mellitus Clinical Trial

Official title:
Microalbuminuria in Children With and Without Diabetes

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00320086
Other study ID # HRRC#04-250
Secondary ID M01RR000997
Status Completed
Phase
First received
Last updated
Start date August 2005
Est. completion date March 2009

Study information
Verified date January 2024
Source University of New Mexico
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of the study is to learn more about Microalbuminuria in children with and without diabetes. Albumin is a protein that may be excreted in the urine. In some conditions, like kidney problems or diabetes, the amount of albumin in the urine increases. The purpose of this study is to measure concentration of albumin in the urine of diabetic children and compare to healthy children.

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.

Recruitment information / eligibility
Status Completed
Enrollment 203
Est. completion date March 2009
Est. primary completion date March 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years to 18 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States University of New Mexico Albuquerque New Mexico

Sponsors (2)
Lead Sponsor Collaborator
University of New Mexico National Center for Research Resources (NCRR)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Subjects With Normal Urinary Protein Excretion in Healthy and Diabetic Children, Assessed Over 1 Day. during hospitalization
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