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

Completed

• Conditions: Obesity; Overweight; Type 1 Diabetes Mellitus
• Interventions: Other: No intervention

• Registration Number: NCT02938806
• Lead Sponsor: University of California, San Diego

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 Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-10-17
• Study First Submitted QC: 2016-10-17
• Study First Posted: 2016-10-19
• Primary Completion: 2019-04
• Study Completion: 2021-12
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-26
• Last Update Posted: 2022-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Obese/overweight children with T1D	No intervention	No intervention
Normal weight children with T1D	No intervention	No intervention
Obese/overweight children, no diabetes	No intervention	No intervention
Healthy, normal weight children	No intervention	No intervention

Primary Outcome Measures

Name	Time	Method
Analysis of gut microbial composition and diversity by 16S rRNA sequencing	2 years

Secondary Outcome Measures

Name	Time	Method
Analysis of urine metabolite concentrations measured by mass spectrometry	2 years

Trial Locations

Locations (1)

Rady Children's Hospital Endocrinology Department; 🇺🇸 San Diego, California, United States