Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-26 @ 5:22 PM
Ignite Modification Date:
2025-12-26 @ 5:22 PM
NCT ID:
NCT02938806
Brief 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).
Detailed 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:
NCT02938806
Study Brief:
Protocol Section:
NCT02938806