Clinical trial NCT04031222: Mechanisms of Inflammation, Immunity, Islet Cell and Intestinal Hormone Changes in Youth at Risk for Diabetes
Official title: Mechanisms of Inflammation, Immunity, Islet Cell and Intestinal Hormone Changes in Youth at Risk for Diabetes (MI4D)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
PreDiabetes
Adolescent Obesity
Inflammation
Metabolic Problems
Insulin Resistance
Gut Microbiome
Immunity
Beta Cell Dysfunction
Gut Hormones
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: University of Toronto
name: University of Guelph
name: Sunnybrook Health Sciences Centre
First posted: 2019-07-24
Enrollment: 52
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adolescents with obesity

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 cardiovascular disease (CVD), in the adolescent population.

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 tolerance test on a separate visit. Lipoprotein abnormalities and intestinal biomarkers, post-lipid ingestion, will also be evaluated. The primary aim is 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 cardiovascular disease (CVD), in the adolescent population.

Eligibility criteria: Inclusion Criteria:

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 Criteria:

1. Known type 2 diabetes
2. Diabetes secondary to medication or surgery
3. Antibodies suggestive of type 1 diabetes
4. Pregnancy
5. Were born by C-section
6. Developmental delay precluding assent/consent
7. Acute illness within the past 3 days (chills, fever, vomiting \> 1x, or diarrhea \> 3x)
8. Taking medications that influence glucose (e.g., steroids, metformin) or lipids (e.g., statins)
9. Have taken prescribed medicine/antibiotics in the three months prior to clinic or study visit
10. Significant chronic illness (e.g., Cushing's Disease, Craniopharyngioma, Hypothalamic Obesity, etc.)
11. Lactose intolerance and/or milk allergy (Study Visit Day 2 Only)
12. Bariatric surgery

Primary outcomes:
measure: Whole body insulin sensitivity index
timeFrame: Through study completion, an average of 2 years.
measure: Microbiome Composition
timeFrame: Through study completion, an average of 3 years.
measure: Inflammatory markers
timeFrame: Through study completion, an average of 3 years.
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Jill K Hamilton, MD
role: PRINCIPAL_INVESTIGATOR
References: