Ignite Creation Date:
2025-12-26 @ 5:22 PM
Ignite Modification Date:
2026-03-03 @ 3:01 PM
Study NCT ID:
NCT02938806
Status:
COMPLETED
Last Update Posted:
2022-05-31
First Post:
2016-10-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Type 1 Diabetes Mellitus and Increased Weight on Gut Microbiome and Urine Metabolome Profiles in Children
Sponsor:
University of California, San Diego
Organization:
Study Overview
Official Title:
The Effects of Type 1 Diabetes Mellitus and Increased Weight on Gut Microbiome and Urine Metabolome Profiles in Children
Status:
COMPLETED
Status Verified Date:
2022-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
* 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: