Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents

Study Overview
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Brief Summary
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This research study collects health-related information and blood samples to better understand how body composition, lifestyle habits, and diet influence meta-inflammatory monocytes (MiMos) in adolescents. The hypothesis of this study is that adolescents at risk for metabolic disease have enhanced MiMo related activities leading to insulin resistance.

Official Title
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The Role of Circulating Meta-Inflammatory Monocytes in Adolescent Insulin Resistance

Conditions
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Type 2 Diabetes, Insulin Resistance, Obesity, Metabolic Disease, PreDiabetes

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Between 14 and 18 years of age Tanner stage 5 (mature adult stage of puberty) Normal weight (BMI ≥ 5th percentile & < 85th percentile), obese weight (BMI percentile ≥ 95th percentile), and/or pre-diabetes (HbA1c > 5.7%) Exclusion Criteria: Currently pregnant Use medications known to affect glucose metabolism (immunosuppressive medications, cancer medications, or high dose steroids) Prior diagnosis of autoimmune disease, cancer, or a cognitive or perceptual disability Allergies or intolerance to milk, soy, or palm oil

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Normal weight<br>BMI ≥ 5th percentile & < 85th percentile | |
| Obese weight<br>BMI ≥ 95th percentile | |
| PreDiabetes<br>HbA1c > 5.7% | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose (OGTT) | Plasma Glucose (mg/dL) will be measured prior to, and throughout, an Oral Glucose Tolerance Test (OGTT). Measurements will be taken at baseline (fasting) and 30, 60, 90 and 120 minutes after consumption of glucose dose | 120 minutes | 
| Insulin (OGTT) | Plasma Insulin (µU/mL) will be measured prior to, and throughout, an Oral Glucose Tolerance Test (OGTT). Measurements will be taken at baseline (fasting) and 30, 60, 90 and 120 minutes after consumption of glucose dose | 120 minutes | 
| Glucose (MMTT) | Plasma Glucose (mg/dL) will be measured prior to, and throughout, a Mixed Meal Tolerance Test (MMTT). Measurements will be taken at baseline (fasting) and 30, 60, 90, 120 and 180 minutes after consumption of high fat shake. | 180 minutes | 
| Insulin (MMTT) | Plasma Insulin (µU/mL) will be measured prior to, and throughout, a Mixed Meal Tolerance Test (MMTT). Measurements will be taken at baseline (fasting) and 30, 60, 90, 120 and 180 minutes after consumption of high fat shake. | 180 minutes | 
| Monocyte /macrophage populations by flow cytometry | Frequencies by flow cytometry. Measurements will be taken at baseline sample and 180 minutes after consumption of high fat shake | 180 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Free fatty acids (MMTT) | Serum Free fatty acids (mmol/L) will be measured prior to, and throughout, a Mixed Meal Tolerance Test (MMTT). Measurements will be taken at baseline (fasting) and 30, 60, 90, 120 and 180 minutes after consumption of high fat shake | 180 minutes | 
| Triglycerides (MMTT) | Serum Triglycerides (mg/dL) will be measured prior to, and throughout, a Mixed Meal Tolerance Test (MMTT). Measurements will be taken at baseline (fasting) and 30, 60, 90, 120 and 180 minutes after consumption of high fat shake | 180 minutes |