The Effects of Type 1 Diabetes Mellitus and Increased Weight on Gut Microbiome and Urine Metabolome Profiles in Children
Study Details
Study Description
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 | Phase |
|---|---|---|
|
Detailed Description
The investigators will obtain stool and urine samples from subjects aged 7-17 years in 4 groups:
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Group 1: Obese or overweight children within 3 years of diagnosis of T1D
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Group 2: Normal weight children within 3 years of diagnosis of T1D
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Group 3: Obese or overweight children without T1D
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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
Arms and Interventions
| Arm | 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
Primary Outcome Measures
- Analysis of gut microbial composition and diversity by 16S rRNA sequencing [2 years]
Secondary Outcome Measures
- Analysis of urine metabolite concentrations measured by mass spectrometry [2 years]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age 7 to 17 years
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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%)
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Diabetes duration < 3 years
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Presence of pancreatic autoimmunity (GAD65, ICA512, or insulin autoantibody positivity)
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Adult caregiver willing to actively support study participation
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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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Rady Children's Hospital Endocrinology Department | San Diego | California | United States | 92123 |
Sponsors and Collaborators
- University of California, San Diego
Investigators
- Principal Investigator: Jane Kim, MD, University of California, San Diego
Study Documents (Full-Text)
None provided.More Information
Publications
- Boerner BP, Sarvetnick NE. Type 1 diabetes: role of intestinal microbiome in humans and mice. Ann N Y Acad Sci. 2011 Dec;1243:103-18. doi: 10.1111/j.1749-6632.2011.06340.x. Review.
- Dunne JL, Triplett EW, Gevers D, Xavier R, Insel R, Danska J, Atkinson MA. The intestinal microbiome in type 1 diabetes. Clin Exp Immunol. 2014 Jul;177(1):30-7. doi: 10.1111/cei.12321. Review.
- Zimny D, Szatkowska M, Połubok J, Maciaszek J, Machaj M, Barg E. [The use of metabolomics in medicine - some examples of oncological and metabolic diseases]. Pediatr Endocrinol Diabetes Metab. 2015;20(2):55-62. doi: 10.18544/PEDM-20.02.0003. Review. Polish.
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