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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02938806
• Other study ID #: #160113
• Status: Completed
• Start date: June 2016
• Est. completion date: December 2021

Study information

• Verified date: May 2022
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 2021
• Est. primary completion date: April 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Obesity
• Overweight
• Type 1 Diabetes Mellitus
• Weight Gain

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
United States	Rady Children's Hospital Endocrinology Department	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. Review. — View 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. Review. Polish. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analysis of gut microbial composition and diversity by 16S rRNA sequencing		2 years
Secondary	Analysis of urine metabolite concentrations measured by mass spectrometry		2 years