Diabetes Mellitus
Conditions
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.
Interventions
None listed
Sponsors
National Center for Research Resources (NCRR)
University of New Mexico
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Subjects With Normal Urinary Protein Excretion in Healthy and Diabetic Children, Assessed Over 1 Day. | during hospitalization |
Countries
United States
Participant flow
Recruitment details
Patients were recruited from the University of New Mexico and via advertising and referral by other physicians.
Participants by arm
| Arm | Count |
|---|---|
| Arm 1 Control Arm: children 6 to 18 years old without:
* kidney disease
* abnormal body temperature
* history of documented urinary tract infection
* metabolic disease
* circulatory disease
* liver disease
* strenuous exercise in prior 24 hours
* nocturnal enuresis | 91 |
| Arm 2 Diabetes Arm: children 6 to 18 years old with Type I or Type II Diabetes without:
* 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 | 112 |
| Total | 203 |
Baseline characteristics
| Characteristic | Arm 1 | Arm 2 | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 91 Participants | 112 Participants | 203 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 45 Participants | 57 Participants | 102 Participants |
| Sex: Female, Male Male | 46 Participants | 55 Participants | 101 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 203 |
| serious Total, serious adverse events | 0 / 203 |
Outcome results
Primary
Number of Subjects With Normal Urinary Protein Excretion in Healthy and Diabetic Children, Assessed Over 1 Day.
Time frame: during hospitalization
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1 | Number of Subjects With Normal Urinary Protein Excretion in Healthy and Diabetic Children, Assessed Over 1 Day. | 91 participants |
| Arm 2 | Number of Subjects With Normal Urinary Protein Excretion in Healthy and Diabetic Children, Assessed Over 1 Day. | 112 participants |
Comparison: ANOVAp-value: <0.05ANOVA