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 :
Completed
First Posted : October 19, 2016
Last Update Posted : May 31, 2022
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Condition or disease | Intervention/treatment |
---|---|
Obesity Overweight Type 1 Diabetes Mellitus | Other: No intervention |
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 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 |
Actual Primary Completion Date : | April 2019 |
Actual Study Completion Date : | December 2021 |

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 |
- Analysis of gut microbial composition and diversity by 16S rRNA sequencing [ Time Frame: 2 years ]
- Analysis of urine metabolite concentrations measured by mass spectrometry [ Time Frame: 2 years ]
Biospecimen Retention: Samples Without DNA

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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 |
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

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
United States, California | |
Rady Children's Hospital Endocrinology Department | |
San Diego, California, United States, 92123 |
Principal Investigator: | Jane Kim, MD | University of California, San Diego |
Responsible Party: | Dr Jane Kim, Assistant Professor, University of California, San Diego |
ClinicalTrials.gov Identifier: | NCT02938806 |
Other Study ID Numbers: |
#160113 |
First Posted: | October 19, 2016 Key Record Dates |
Last Update Posted: | May 31, 2022 |
Last Verified: | May 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Diabetes Mellitus Diabetes Mellitus, Type 1 Overweight Weight Gain Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Autoimmune Diseases Immune System Diseases Body Weight Body Weight Changes |