Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age14-18
SponsorUniversity of Michigan
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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 population
Participants may be recruited from a variety of sites including University of Michigan clinical sites, non-University of Michigan clinical sites, local communities and schools throughout Southeast Michigan, and the University of Michigan campus.
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
175 Participants
are grouped into 5 trial groupsGroup A: Normal weight
Group B: Obese weight
Group C: PreDiabetes
Group D: Type 2 Diabetes
Group E: Overweight
Trial outcomes
Primary outcomes
1
Glucose (OGTT)
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
Time frame
120 minutes2
Insulin (OGTT)
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
Time frame
120 minutes3
Glucose (MMTT)
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.
Time frame
180 minutes4
Insulin (MMTT)
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.
Time frame
180 minutesSecondary outcomes
1
Free fatty acids (MMTT)
Serum Free fatty acids (mmol/L) 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
Time frame
180 minutes2
Triglycerides (MMTT)
Serum Triglycerides (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
Time frame
180 minutesSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Michigan
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Source ClinicalTrials.gov