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This study employs a cross-sectional design to profile the gut microbiome and urine metabolome in overweight/obese children with type 1 diabetes (T1D).
The investigators will obtain stool and urine samples from subjects aged 7-17 years in 4 groups:
Type 1 diabetes will be defined according to American Diabetes Association criteria along with the presence of pancreatic autoantibodies (GAD65, ICA512, or insulin autoantibodies). Obese and overweight status will be defined by BMI >85th percentile for age and gender according to CDC criteria.
All subjects will provide one-time stool and first morning urine sample. Overweight or obese subjects will additionally have a point of care blood glucose and hemoglobin A1c measurement to ensure that they do not have diabetes.
The investigators will perform 16S rRNA sequencing of stool bacteria and mass spectrometry measurement of urine metabolites.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Obese/overweight children with T1D | No intervention |
| |
| Normal weight children with T1D | No intervention |
| |
| Obese/overweight children, no diabetes | No intervention |
| |
| Healthy, normal weight children | No intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other | No intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Analysis of gut microbial composition and diversity by 16S rRNA sequencing | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Analysis of urine metabolite concentrations measured by mass spectrometry | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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Children aged 7-17 years with/without T1DM and with/without obese/overweight status in San Diego, California
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| Name | Affiliation | Role |
|---|---|---|
| Jane Kim, MD | University of California, San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rady Children's Hospital Endocrinology Department | San Diego | California | 92123 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22211896 | Background | Boerner BP, Sarvetnick NE. Type 1 diabetes: role of intestinal microbiome in humans and mice. Ann N Y Acad Sci. 2011 Dec;1243:103-18. doi: 10.1111/j.1749-6632.2011.06340.x. | |
| 24628412 | Background | Dunne JL, Triplett EW, Gevers D, Xavier R, Insel R, Danska J, Atkinson MA. The intestinal microbiome in type 1 diabetes. Clin Exp Immunol. 2014 Jul;177(1):30-7. doi: 10.1111/cei.12321. |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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Stool Urine
| 26615014 | Background | Zimny D, Szatkowska M, Polubok J, Maciaszek J, Machaj M, Barg E. [The use of metabolomics in medicine - some examples of oncological and metabolic diseases]. Pediatr Endocrinol Diabetes Metab. 2015;20(2):55-62. doi: 10.18544/PEDM-20.02.0003. Polish. |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |