Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents

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

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Estimated): 175

Contacts and Locations

• Study Contact: Name: The Singer Lab Team; Phone Number: (734) 615-4938; Email: MiMoStudy@med.umich.edu

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Participants may be recruited from a variety of sites including University of Michigan clinical sites, non-University of Michigan clinical sites, local communities and schools throughout Southeast Michigan, and the University of Michigan campus.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort
Normal weight; BMI ≥ 5th percentile & < 85th percentile
Obese weight; BMI ≥ 95th percentile
PreDiabetes; HbA1c > 5.7%
Type 2 Diabetes; Diagnosed with Type 2 Diabetes
Overweight; BMI > 86th percentile and <94th percentile

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Kanakadurga Singer, MA, MD, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): September 6, 2023
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: June 10, 2023
• First Submitted That Met QC Criteria: August 17, 2023
• First Posted (Actual): August 23, 2023

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Nutrition Disorders; Overnutrition; Body Weight; Glucose Metabolism Disorders; Diabetes Mellitus; Hyperinsulinism; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Diabetes Mellitus, Type 2; Insulin Resistance; Metabolic Diseases; Prediabetic State
• Other Study ID Numbers: HUM00208301; R01DK130864 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Genomic and associated phenotypic data will be shared through NIH-designated data repositories.
• IPD Sharing Time Frame: Genotype/sequencing and phenotype data will be submitted after the genotyping/sequencing data have been cleaned. Following submission, data will be released within six months.
• IPD Sharing Access Criteria: In regards to genomic data, individual-level data will be deidentified and made available through controlled-access.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No