Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Type 2 Diabetes, Insulin Resistance, Obesity, Metabolic Disease. Basic parameters: 14 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Role of Circulating Meta-Inflammatory Monocytes in Adolescent Insulin Resistance
Overview
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.
Primary outcome measures
- 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]
Secondary outcome measures (2)
- Free fatty acids (MMTT) [Time frame: 180 minutes]
- Triglycerides (MMTT) [Time frame: 180 minutes]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- University of Michigan — Ann Arbor
Identifiers
NCT: NCT06007404 · HUM00208301 · R01DK130864