Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
Recruiting · NCT06007404 · Observational (researchers observe without assigning treatment) · Lead sponsor: University of Michigan
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Age range
14 Years to 18 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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
Where it is running
1 location listed across 1 US state.
- University of Michigan - Ann Arbor, Michigan, United States