Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents

Obesity Clinical Trial

Official title:

The Role of Circulating Meta-Inflammatory Monocytes in Adolescent Insulin Resistance

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06007404
• Other study ID #: HUM00208301
• Secondary ID: R01DK130864
• Status: Recruiting
• Start date: September 6, 2023
• Est. completion date: September 2027

Study information

• Verified date: May 2024
• Source: University of Michigan
• Contact: The Singer Lab Team
• Phone: (734) 615-4938
• Email: MiMoStudy[@]med.umich.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 175
• Est. completion date: September 2027
• Est. primary completion date: September 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 18 Years

Eligibility

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), 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

Related Conditions & MeSH terms

• Insulin Resistance
• Metabolic Disease
• Metabolic Diseases
• Obesity
• PreDiabetes
• Type 2 Diabetes

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	120 minutes
Primary	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	120 minutes
Primary	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.	180 minutes
Primary	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.	180 minutes
Primary	Monocyte /macrophage populations by flow cytometry	Frequencies by flow cytometry. Measurements will be taken at baseline sample and 180 minutes after consumption of high fat shake	180 minutes
Secondary	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	180 minutes
Secondary	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	180 minutes