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

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ClinicalTrials.gov Identifier: NCT02938806
Recruitment Status : Active, not recruiting
First Posted : October 19, 2016
Last Update Posted : June 20, 2018
Sponsor:
Information provided by (Responsible Party):
Dr Jane Kim, University of California, San Diego

Study Description
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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).

Condition or disease Intervention/treatment
Obesity Overweight Type 1 Diabetes Mellitus Other: No intervention

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 Design
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Study Type : Observational
Actual Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: The Effects of Type 1 Diabetes Mellitus and Increased Weight on Gut Microbiome and Urine Metabolome Profiles in Children
Study Start Date : June 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Obese/overweight children with T1D
No intervention
 Other: No intervention
No intervention
Normal weight children with T1D
No intervention
 Other: No intervention
No intervention
Obese/overweight children, no diabetes
No intervention
 Other: No intervention
No intervention
Healthy, normal weight children
No intervention
 Other: No intervention
No intervention


Outcome Measures
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Primary Outcome Measures :
  1. Analysis of gut microbial composition and diversity by 16S rRNA sequencing [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Analysis of urine metabolite concentrations measured by mass spectrometry [ Time Frame: 2 years ]

Biospecimen Retention:   Samples Without DNA
Stool Urine

Eligibility Criteria
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Ages Eligible for Study:   7 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Children aged 7-17 years with/without T1DM and with/without obese/overweight status in San Diego, California
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02938806


Locations
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United States, California
Rady Children's Hospital Endocrinology Department
San Diego, California, United States, 92123
Sponsors and Collaborators
University of California, San Diego
Investigators
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Principal Investigator: Jane Kim, MD University of California, San Diego
More Information
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Publications:

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Responsible Party: Dr Jane Kim, Assistant Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT02938806     History of Changes
Other Study ID Numbers: #160113
First Posted: October 19, 2016    Key Record Dates
Last Update Posted: June 20, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Overweight
Weight Gain
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Body Weight
Signs and Symptoms
Body Weight Changes