Microalbuminuria in Children With and Without Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00320086
Recruitment Status : Unknown
Verified September 2008 by University of New Mexico.
Recruitment status was:  Recruiting
First Posted : May 3, 2006
Last Update Posted : January 14, 2009
National Center for Research Resources (NCRR)
Information provided by:
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.

Condition or disease
Diabetes Mellitus

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 : Observational
Estimated Enrollment : 220 participants
Time Perspective: Prospective
Official Title: Microalbuminuria in Children With and Without Diabetes
Study Start Date : August 2005
Estimated Study Completion Date : November 2008

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Primary care/specialty clinincs and community

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00320086

Contact: Franceska Kelly (505) 272-9889

United States, New Mexico
University of New Mexico Recruiting
Albuquerque, New Mexico, United States, 87131
Contact: Franceska Kelly    505-272-9889   
Sponsors and Collaborators
University of New Mexico
National Center for Research Resources (NCRR)
Principal Investigator: Aaron Jacobs University of New Mexico- Pediatric department

Responsible Party: Aaron Jacobs, MD, University of New Mexico Identifier: NCT00320086     History of Changes
Other Study ID Numbers: GCRC MO1RROO997
First Posted: May 3, 2006    Key Record Dates
Last Update Posted: January 14, 2009
Last Verified: September 2008

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases