This study is in progress, not accepting new patients

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

a study on Obesity Diabetes Diabetes Type 1

Summary

for people ages 7-17 (full criteria)
healthy people welcome
at UCSD
study started
estimated completion
Jane Kim, MD(ucsd)

Description

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).

Details

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.

Keywords

Obesity Overweight Type 1 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 1 Weight Gain No intervention

Eligibility

You can join if…

Open to people ages 7-17

  • 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

You CAN'T join if...

  • Other significant organ system illness or condition (including psychiatric or developmental disorder) that, in the opinion of the investigator, would prevent participation

Location

  • Rady Children's Hospital Endocrinology Department
    San Diego California 92123 United States

Lead Scientist

  • Jane Kim, MD (ucsd)
    Assistant Clinical Professor, Pediatrics. Authored (or co-authored) 24 research publications

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Diego
ID
NCT02938806
Study Type
Observational
Last Updated