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| ID | Type | Description | Link |
|---|---|---|---|
| M01RR000997 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Research Resources (NCRR) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. | ||
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Normal Urinary Protein Excretion in Healthy and Diabetic Children, Assessed Over 1 Day. | during hospitalization |
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Inclusion Criteria:
Exclusion Criteria:
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Primary care/specialty clinincs and community
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| Name | Affiliation | Role |
|---|---|---|
| Aaron Jacobs | University of New Mexico- Pediatric department | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of New Mexico | Albuquerque | New Mexico | 87131 | United States |
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Patients were recruited from the University of New Mexico and via advertising and referral by other physicians.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1 | Control Arm: Evaluate Normal Urinary Protein Excretion in Healthy and Diabetic Children |
| FG001 | Arm 2 | Diabetes Arm: Children 6 to 18 years old with Type I or Type II Diabetes |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1 | Control Arm: children 6 to 18 years old without:
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| BG001 | Arm 2 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Subjects With Normal Urinary Protein Excretion in Healthy and Diabetic Children, Assessed Over 1 Day. | Posted | Number | participants | during hospitalization |
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AE data collected from study initiation to study closure. Individual Study visits: Adverse Event data was collected up to 72 hours after end of study visit. Study lab results reviewed by a study investigator as soon as received from lab.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1 | dibetes vs Healthy |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Aaron Jacobs, MD | University of New Mexico | (505)272-5551 | Ajacobs@salud.unm.edu |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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Diabetes Arm: children 6 to 18 years old with Type I or Type II Diabetes without:
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| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| 0 |
| 203 |
| 0 |
| 203 |
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