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Clinical Trial Summary

This study employs a cross-sectional design to profile the gut microbiome and urine metabolome in overweight/obese children with type 1 diabetes (T1D).


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02938806
Study type Observational
Source University of California, San Diego
Contact
Status Completed
Phase
Start date June 2016
Completion date December 2021

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