Mechanisms of Inflammation, Immunity, Islet Cell and Intestinal Hormone Changes in Youth at Risk for Diabetes (MI4D)

The Hospital for Sick Children

Status: Completed

Conditions: Inflammation; Immunity; Gut Microbiome; Gut Hormones; Insulin Resistance; Metabolic Problems; Obesity; Beta Cell Dysfunction; Adolescent Obesity; PreDiabetes

Study type: Observational

Funder types: Other

Identifiers

NCT04031222

1000055159

Details and patient eligibility

About

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.

Full 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.

Enrollment: 52 patients

Sex: All

Ages: 12 to 18 years old

Volunteers: No Healthy Volunteers

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