Clinical trial

Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents

Recruiting now · Not applicable · 1 countries · Registry ID NCT06007404

Recruiting nowNot applicableObservational

What this study 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age14 Years to 18 Years

SexAll

Healthy volunteersAccepted

ConditionType 2 Diabetes, Insulin Resistance, Obesity, Metabolic Disease, PreDiabetes

Full registry 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

Treatments and study arms

The registry does not list a named intervention.

Primary outcomes

Glucose (OGTT)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

Insulin (OGTT)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

Glucose (MMTT)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.

Insulin (MMTT)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.

Monocyte /macrophage populations by flow cytometry180 minutes

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

Study locations

1 locations were listed when this page was built. The first 40 are shown.

University of Michigan🇺🇸 Ann Arbor, Michigan, United States

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