Microalbuminuria in Children With and Without Diabetes

NCT ID: NCT00320086

Last Updated: 2024-01-31

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 203 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2005-08-31
• Study Completion Date: 2009-03-31

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.

Conditions

Diabetes Mellitus

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

diabetes group

6 to 18 years old males and females, with confirmed diagnosis of Type I or Type II Diabetes with no history of: kidney disease, documented urinary tract infection, cardiovascular disease, liver disease, nocturnal enuresis, metabolic disease other that diabetes, abnormal body temperature at start of study visit, no strenuous exercise 24 hours prior to start of study visit.

No interventions assigned to this group

control group

6 to 18 years old males and females, with no history of: Type I or Type II Diabetes and/or other metabolic disease, kidney disease, documented urinary tract infection, cardiovascular disease, liver disease, nocturnal enuresis, abnormal body temperature at start of study visit, no strenuous exercise 24 hours prior to start of study visit.

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Center for Research Resources (NCRR)

NIH

Sponsor Role: collaborator

University of New Mexico

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aaron Jacobs

Role: PRINCIPAL_INVESTIGATOR

University of New Mexico- Pediatric department

Locations

University of New Mexico

Albuquerque, New Mexico, United States

Countries

United States

Other Identifiers

M01RR000997

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HRRC#04-250

Identifier Type: -

Identifier Source: org_study_id