Status:
COMPLETED
Mechanisms of Inflammation, Immunity, Islet Cell and Intestinal Hormone Changes in Youth at Risk for Diabetes
Lead Sponsor:
The Hospital for Sick Children
Collaborating Sponsors:
University of Toronto
University of Guelph
Conditions:
Obesity
PreDiabetes
Eligibility:
All Genders
12-18 years
Brief Summary
This study intends to assess the role of inflammation in insulin resistant conditions (i.e., obesity and pre-diabetes) and the subsequent development of disease, such as type 2 diabetes (T2D) and card...
Detailed Description
This study proposes to characterize inflammatory biomarkers, insulin resistance and fecal microbiome composition in obese/pre-diabetic adolescents after glucose ingestion, followed by an oral fat tole...
Eligibility Criteria
Inclusion
- 1\. Adolescents aged 12 - 18 years old with obesity (defined as body mass index (BMI) \>97th percentile based on their age- and sex-specific World Health Organization growth chart)
Exclusion
- Known type 2 diabetes
- Diabetes secondary to medication or surgery
- Antibodies suggestive of type 1 diabetes
- Pregnancy
- Were born by C-section
- Developmental delay precluding assent/consent
- Acute illness within the past 3 days (chills, fever, vomiting \> 1x, or diarrhea \> 3x)
- Taking medications that influence glucose (e.g., steroids, metformin) or lipids (e.g., statins)
- Have taken prescribed medicine/antibiotics in the three months prior to clinic or study visit
- Significant chronic illness (e.g., Cushing's Disease, Craniopharyngioma, Hypothalamic Obesity, etc.)
- Lactose intolerance and/or milk allergy (Study Visit Day 2 Only)
- Bariatric surgery
Key Trial Info
Start Date :
May 19 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2019
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT04031222
Start Date
May 19 2017
End Date
March 1 2019
Last Update
September 13 2022
Active Locations (1)
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1
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G1X8