Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents

Recruiting

• Conditions: Insulin Resistance; PreDiabetes; Obesity; Type 2 Diabetes; Metabolic Disease

• Registration Number: NCT06007404
• Lead Sponsor: University of Michigan

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-10
• Study First Submitted QC: 2023-08-17
• Study First Posted: 2023-08-23
• Study Start: 2023-09-06
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-03
• Last Update Posted: 2025-05-07
• Primary Completion: 2027-09
• Study Completion: 2027-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 175

Inclusion Criteria

• Between 14 and 18 years of age
• Tanner stage 4 or 5 (mature adult stage of puberty)
• Normal weight (BMI ≥ 5th percentile & < 85th percentile), overweight (BMI > 86th percentile) & < 94th percentile), obese weight (BMI percentile ≥ 95th percentile), and/or pre-diabetes (HbA1c > 5.7%)
• For Type 2 Diabetes cohort, diagnosis of Type 2 Diabetes

Exclusion Criteria

• Currently pregnant
• Use medications known to affect glucose metabolism (immunosuppressive medications, cancer medications, or high dose steroids), unless prescribed for Type 2 Diabetes management
• Prior diagnosis of autoimmune disease, cancer, or a cognitive or perceptual disability that would inhibit following directions of study staff
• Allergies or intolerance to milk, soy, or palm oil

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.
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.
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

Name	Time	Method
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

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States