Microalbuminuria in Children With and Without Diabetes
Recruitment status was Recruiting
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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 |
| Estimated Enrollment: | 220 |
| Study Start Date: | August 2005 |
| Estimated Study Completion Date: | November 2008 |
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 |
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
Contacts and Locations| Contact: Franceska Kelly | (505) 272-9889 | fmkelly@salud.unm.edu |
| 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 | |
| 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 May 19, 2013