Microalbuminuria in Children With and Without Diabetes

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2008 by University of New Mexico.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
University of New Mexico
ClinicalTrials.gov Identifier:
NCT00320086
First received: April 28, 2006
Last updated: January 13, 2009
Last verified: September 2008
  Purpose

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
Diabetes Mellitus

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Microalbuminuria in Children With and Without Diabetes

Resource links provided by NLM:


Further study details as provided by University of New Mexico:

Estimated Enrollment: 220
Study Start Date: August 2005
Estimated Study Completion Date: November 2008
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.

  Eligibility

Ages Eligible for Study:   6 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Primary care/specialty clinincs and community

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00320086

Contacts
Contact: Franceska Kelly (505) 272-9889 fmkelly@salud.unm.edu

Locations
United States, New Mexico
University of New Mexico Recruiting
Albuquerque, New Mexico, United States, 87131
Contact: Franceska Kelly    505-272-9889    FMKelly@salud.unm.edu   
Sponsors and Collaborators
University of New Mexico
Investigators
Principal Investigator: Aaron Jacobs University of New Mexico- Pediatric department
  More Information

No publications provided

Responsible Party: Aaron Jacobs, MD, University of New Mexico
ClinicalTrials.gov Identifier: NCT00320086     History of Changes
Other Study ID Numbers: GCRC MO1RROO997
Study First Received: April 28, 2006
Last Updated: January 13, 2009
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 16, 2014