The Effects of Type 1 Diabetes Mellitus and Increased Weight on Gut Microbiome and Urine Metabolome Profiles in Children

Study Overview
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Brief Summary
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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).

Detailed Description
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The investigators will obtain stool and urine samples from subjects aged 7-17 years in 4 groups: Group 1: Obese or overweight children within 3 years of diagnosis of T1D Group 2: Normal weight children within 3 years of diagnosis of T1D Group 3: Obese or overweight children without T1D Group 4: Normal weight children without T1D 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.

Official Title
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The Effects of Type 1 Diabetes Mellitus and Increased Weight on Gut Microbiome and Urine Metabolome Profiles in Children

Conditions
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Overweight, Obesity, Type 1 Diabetes Mellitus

Intervention / Treatment
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* Other: No intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 7 to 17 years Diagnosis of diabetes will be defined by current American Diabetes Association criteria ° (fasting glucose > 126 mg/dl, 2 hour OGTT glucose > 200 mg/dl; random glucose > 200 with symptoms of hyperglycemia; or HbA1c > 6.5%) Diabetes duration < 3 years Presence of pancreatic autoimmunity (GAD65, ICA512, or insulin autoantibody positivity) Adult caregiver willing to actively support study participation Signed parental informed consent form and minor child informed assent form Exclusion Criteria: Other significant organ system illness or condition (including psychiatric or developmental disorder) that, in the opinion of the investigator, would prevent participation

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Obese/overweight children with T1D<br>No intervention | Other: No intervention<br>* No intervention<br>|
| Normal weight children with T1D<br>No intervention | Other: No intervention<br>* No intervention<br>|
| Obese/overweight children, no diabetes<br>No intervention | Other: No intervention<br>* No intervention<br>|
| Healthy, normal weight children<br>No intervention | Other: No intervention<br>* No intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analysis of gut microbial composition and diversity by 16S rRNA sequencing |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analysis of urine metabolite concentrations measured by mass spectrometry |  | 2 years |