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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01HD074559-05 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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The purpose of this study is to evaluate the longitudinal test performance of an array of conventional biomarkers of glycemia, including Hemoglobin A1c (HbA1c), and novel metabolomic biomarkers for identifying progression of glucose tolerance (normal to prediabetes or prediabetes to diabetes) in an overweight and obese pediatric cohort.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Overweight or Obese Group (visits #1-4) | Children and young adults who are 8 to 22 years of age, who have risk factors for diabetes such as being overweight. Overweight or obese, as defined by a BMI ≥ 85th percentile & <95th percentile or BMI ≥ 95th percentile, respectively. Study participants cannot be pregnant or currently take medications known to affect glucose metabolism including, metformin, oral steroids, sulfonylureas, and insulin. | ||
| Group 2: Overweight or Obese Group (visits #3-4) | Children and young adults who are 8 to 22 years of age, who have risk factors for diabetes such as being overweight, or children and young adults who previously participated in the study (completed visits #1-2 in previous study phase). Overweight or obese, as defined by a BMI ≥ 85th percentile & <95th percentile or BMI ≥ 95th percentile, respectively. Study participants cannot be pregnant or currently take medications known to affect glucose metabolism including, metformin, oral steroids, sulfonylureas, and insulin. | ||
| Group 3: Normal Weight Control Group | Children and adolescents who are 8 to 17 years of age, who have do not have risk factors for diabetes such as being overweight or a history of type 2 diabetes in the family. Healthy weight, as defined by a BMI ≥ 5th percentile & < 85th percentile. Study participants cannot be pregnant or currently take medications known to affect glucose metabolism including, metformin, oral steroids, sulfonylureas, and insulin. |
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| Measure | Description | Time Frame |
|---|---|---|
| Progression of glucose tolerance | Normal glucose tolerance, prediabetes, or diabetes | Up to 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will consist of normal weight, overweight or obese individuals aged 8 to 17 years at visits #1 and #2, and can be as old as 22 years for follow-up visits #3 and #4. Participants will be recruited from a variety of sites including University Michigan clinical sites, non-University of Michigan clinical sites, schools in the local area, and the University Michigan medical school campus. Participants from Group 2 (visits #3-4) completed visits #1-2 in 2007-2013 and formally agreed to be re-contacted for study purposes.
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| Name | Affiliation | Role |
|---|---|---|
| Joyce Lee, MD, MPH | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
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| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| D063766 | Pediatric Obesity |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| D004700 | Endocrine System Diseases |
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |