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Completed

NCT Number: NCT00320086

Microalbuminuria in Children With and Without Diabetes

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.

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Key information

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of New Mexico

Albuquerque, New Mexico, 87131, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Number of Subjects With Normal Urinary Protein Excretion in Healthy and Diabetic Children, Assessed Over 1 Day.

    Time frame: during hospitalization

Sponsors and collaborators

Lead sponsor

University of New Mexico

Other

Collaborators

  • National Center for Research Resources (NCRR)

Registry information

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
May 3, 2006
Registry last updated
Jan 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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