Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Normal weight BMI ≥ 5th percentile & < 85th percentile |
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| Obese weight BMI ≥ 95th percentile |
|
| PreDiabetes HbA1c > 5.7% |
Outcome Measures
Primary Outcome Measures
- Glucose (OGTT) [120 minutes]
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
- Insulin (OGTT) [120 minutes]
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
- Glucose (MMTT) [180 minutes]
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.
- Insulin (MMTT) [180 minutes]
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.
- Monocyte /macrophage populations by flow cytometry [180 minutes]
Frequencies by flow cytometry. Measurements will be taken at baseline sample and 180 minutes after consumption of high fat shake
Secondary Outcome Measures
- Free fatty acids (MMTT) [180 minutes]
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
- Triglycerides (MMTT) [180 minutes]
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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Between 14 and 18 years of age
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Tanner stage 5 (mature adult stage of puberty)
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Normal weight (BMI ≥ 5th percentile & < 85th percentile), obese weight (BMI percentile ≥ 95th percentile), and/or pre-diabetes (HbA1c > 5.7%)
Exclusion Criteria:
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Currently pregnant
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Use medications known to affect glucose metabolism (immunosuppressive medications, cancer medications, or high dose steroids)
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Prior diagnosis of autoimmune disease, cancer, or a cognitive or perceptual disability
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Allergies or intolerance to milk, soy, or palm oil
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Michigan | Ann Arbor | Michigan | United States | 48109 |
Sponsors and Collaborators
- University of Michigan
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
- Principal Investigator: Kanakadurga Singer, MA, MD, University of Michigan
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HUM00208301
- R01DK130864