Status:
RECRUITING
Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
Lead Sponsor:
University of Michigan
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Type 2 Diabetes
Insulin Resistance
Eligibility:
All Genders
14-18 years
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 adolesc...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 6 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
175 Patients enrolled
Trial Details
Trial ID
NCT06007404
Start Date
September 6 2023
End Date
September 1 2027
Last Update
May 7 2025
Active Locations (1)
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1
University of Michigan
Ann Arbor, Michigan, United States, 48109