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NCT Number: NCT06007404

Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents

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.

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Key information

Conditions

Type 2 Diabetes Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Disease Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms PreDiabetes Prediabetic State Signs and Symptoms

Age range

14 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Glucose (OGTT)

    Time frame: 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

  2. Insulin (OGTT)

    Time frame: 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

  3. Glucose (MMTT)

    Time frame: 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.

  4. Insulin (MMTT)

    Time frame: 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.

  5. Monocyte /macrophage populations by flow cytometry

    Time frame: 180 minutes

    Frequencies by flow cytometry. Measurements will be taken at baseline sample and 180 minutes after consumption of high fat shake

Secondary outcomes

  1. Free fatty acids (MMTT)

    Time frame: 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

  2. Triglycerides (MMTT)

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

The Singer Lab Team

CONTACT

[email protected]

(734) 615-4938

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Aug 23, 2023
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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