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Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06007404
Enrollment
175
Registered
2023-08-23
Start date
2023-09-06
Completion date
2027-09-01
Last updated
2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

None listed

Sponsors

University of Michigan
Lead SponsorOTHER
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
CollaboratorNIH

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
14 Years to 18 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Glucose (OGTT)120 minutesPlasma 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 minutesPlasma 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 minutesPlasma 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 minutesPlasma 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 cytometry180 minutesFrequencies by flow cytometry. Measurements will be taken at baseline sample and 180 minutes after consumption of high fat shake

Secondary

MeasureTime frameDescription
Free fatty acids (MMTT)180 minutesSerum 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 minutesSerum 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

Countries

United States

Contacts

CONTACTThe Singer Lab Team
MiMoStudy@med.umich.edu(734) 615-4938
PRINCIPAL_INVESTIGATORKanakadurga Singer, MA, MD

University of Michigan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 14, 2026