NCT02938806

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 17, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 19, 2016

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

May 31, 2022

Status Verified

May 1, 2022

Enrollment Period

2.8 years

First QC Date

October 17, 2016

Last Update Submit

May 26, 2022

Conditions

ObesityOverweightType 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Analysis of gut microbial composition and diversity by 16S rRNA sequencing

    2 years

Secondary Outcomes (1)

  • Analysis of urine metabolite concentrations measured by mass spectrometry

    2 years

Study Arms (4)

Obese/overweight children with T1D

No intervention

Other: No intervention

Normal weight children with T1D

No intervention

Other: No intervention

Obese/overweight children, no diabetes

No intervention

Other: No intervention

Healthy, normal weight children

No intervention

Other: No intervention

Interventions

No interventionOTHER

No intervention

Healthy, normal weight childrenNormal weight children with T1DObese/overweight children with T1DObese/overweight children, no diabetes

Eligibility Criteria

Age7 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children aged 7-17 years with/without T1DM and with/without obese/overweight status in San Diego, California

You may qualify if:

  • 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

You may not qualify if:

  • Other significant organ system illness or condition (including psychiatric or developmental disorder) that, in the opinion of the investigator, would prevent participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rady Children's Hospital Endocrinology Department

San Diego, California, 92123, United States

Location

Related 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.

    PMID: 22211896BACKGROUND

  • 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.

    PMID: 24628412BACKGROUND

  • 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.

    PMID: 26615014BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Stool Urine

MeSH Terms

Conditions

ObesityOverweightDiabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Jane Kim, MD

    University of California, San Diego

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 17, 2016

First Posted

October 19, 2016

Study Start

June 1, 2016

Primary Completion

April 1, 2019

Study Completion

December 1, 2021

Last Updated

May 31, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)