Microalbuminuria in Children With and Without Diabetes

Completed

• Conditions: Diabetes Mellitus

• Registration Number: NCT00320086
• Lead Sponsor: University of New Mexico

Brief 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.

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 Timeline

• Study Start: 2005-08
• Study First Submitted: 2006-04-28
• Study First Submitted QC: 2006-04-28
• Study First Posted: 2006-05-03
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Results First Submitted: 2009-07-21
• Status Verified: 2024-01
• Results First Submitted QC: 2024-01-09
• Last Update Submitted: 2024-01-09
• Results First Posted: 2024-01-31
• Last Update Posted: 2024-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 203

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Subjects With Normal Urinary Protein Excretion in Healthy and Diabetic Children, Assessed Over 1 Day.	during hospitalization

Trial Locations

Locations (1)

University of New Mexico; 🇺🇸 Albuquerque, New Mexico, United States