Clinical trial NCT02938806: The Effects of Type 1 Diabetes Mellitus and Increased Weight on Gut Microbiome and Urine Metabolome Profiles in Children
Official title: The Effects of Type 1 Diabetes Mellitus and Increased Weight on Gut Microbiome and Urine Metabolome Profiles in Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Overweight
Type 1 Diabetes Mellitus
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2016-10-19
Enrollment: 120
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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

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).

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.

Eligibility 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

Primary outcomes:
measure: Analysis of gut microbial composition and diversity by 16S rRNA sequencing
timeFrame: 2 years
Secondary outcomes:
measure: Analysis of urine metabolite concentrations measured by mass spectrometry
timeFrame: 2 years
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Rady Children's Hospital Endocrinology Department
state: California
Study officials:
affiliation: University of California, San Diego
name: Jane Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: Zimny D, Szatkowska M, Polubok 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. Polish.