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

Obesity Clinical Trial

— MI4D  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04031222
• Other study ID #: 1000055159
• Status: Completed
• Start date: May 19, 2017
• Est. completion date: March 1, 2019

Study information

• Verified date: September 2022
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: March 1, 2019
• Est. primary completion date: February 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Adolescent Obesity
• Beta Cell Dysfunction
• Gut Hormones
• Gut Microbiome
• Immunity
• Inflammation
• Insulin Resistance
• Metabolic Problems
• Obesity
• Pediatric Obesity
• PreDiabetes

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (4)

Lead Sponsor	Collaborator
The Hospital for Sick Children	Sunnybrook Health Sciences Centre, University of Guelph, University of Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Whole body insulin sensitivity index	Multiple measurements from a 2-hour oral glucose tolerance will be aggregated to arrive at one reported value (ie., insulin in uU/mL units and glucose values in mg/dL units which are measured at baseline, 30 min, 60 min, 90 min, and 120 min during the oral glucose tolerance test will be combined to calculate whole body insulin sensitivity index). There is no unit of measure for whole body insulin sensitivity index. Whole body insulin sensitivity index will be calculated using the following equation: whole body insulin sensitivity index = 10,000 / v [(fasting glucose x fasting insulin) x (mean glucose x mean insulin)].	Through study completion, an average of 2 years.
Primary	Microbiome Composition	We will perform microbiome 16S ribosomal ribonucleic acid (rRNA) sequencing in fecal samples from study participants.	Through study completion, an average of 3 years.
Primary	Inflammatory markers	Cytokines will be measured in plasma and fecal water with Bio-PlexTM arrays providing biomarkers of type 1 diabetes and/or type 2 diabetes progression. As indices of gut microbial translocation, serum lipopolysaccharides (LPS), macrophage secreted cluster of differentiation 14 (CD14) that binds LPS and LPS binding protein (LBP) will be examined.	Through study completion, an average of 3 years.