Recruiting

Observational Study

Sponsor:

University of Michigan

Code:

NCT06007404

Conditions

Type 2 Diabetes

Insulin Resistance

Obesity

Metabolic Disease

PreDiabetes

Eligibility Criteria

Sex: All

Age: 14 - 18

Healthy Volunteers: Accepted

Study Details

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.

Conditions

Type 2 Diabetes

Insulin Resistance

Obesity

Metabolic Disease

PreDiabetes

Study ID

NCT06007404

Start date

Sep 6, 2023

Status verified date

Jul, 2026

Completion date

Sep, 2027

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 14 - 18

Healthy Volunteers: Accepted

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

Enrollment

175 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Primary outcome measure

  • Glucose (OGTT) [ Time Frame: 120 minutes ]
  • Insulin (OGTT) [ Time Frame: 120 minutes ]
  • Glucose (MMTT) [ Time Frame: 180 minutes ]
  • Insulin (MMTT) [ Time Frame: 180 minutes ]
  • Monocyte /macrophage populations by flow cytometry [ Time Frame: 180 minutes ]

Central Contacts and Locations

Central contacts

The Singer Lab Team

(734) 615-4938MiMoStudy@med.umich.edu

Locations

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

More Information

Sponsor

University of Michigan

Last update posted

Jul 13, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Michigan on 2026-07-13.