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

University of California San Diego logo

University of California San Diego

Status

Completed

Conditions

Type 1 Diabetes Mellitus
Overweight
Obesity

Treatments

Other: No intervention

Study type

Observational

Funder types

Other

Identifiers

NCT02938806
#160113

Details and patient eligibility

About

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

Full 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.

Enrollment

120 patients

Sex

All

Ages

7 to 17 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

120 participants in 4 patient groups

Obese/overweight children with T1D
Description:
No intervention
Treatment:
Other: No intervention
Normal weight children with T1D
Description:
No intervention
Treatment:
Other: No intervention
Obese/overweight children, no diabetes
Description:
No intervention
Treatment:
Other: No intervention
Healthy, normal weight children
Description:
No intervention
Treatment:
Other: No intervention

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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