Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents

University of Michigan

Status: Enrolling

Conditions: Insulin Resistance; Obesity; Metabolic Disease; Type 2 Diabetes; PreDiabetes

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT06007404

R01DK130864 (U.S. NIH Grant/Contract)

HUM00208301

Details and patient eligibility

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.

Enrollment: 175 estimated patients

Sex: All

Ages: 14 to 18 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

175 participants in 5 patient groups

Normal weight

Description:

BMI ≥ 5th percentile \& \< 85th percentile

Obese weight

Description:

BMI ≥ 95th percentile

PreDiabetes

Description:

HbA1c \> 5.7%

Type 2 Diabetes

Description:

Diagnosed with Type 2 Diabetes

Overweight

Description:

BMI \> 86th percentile and \<94th percentile