Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents

NCT06007404 | Recruiting

• 2 other identifiers: HUM00208301R01DK130864
• Study Type: observational
• Target: 175
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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 Outcomes (2)

• Free fatty acids (MMTT)

  180 minutes

• Triglycerides (MMTT)

  180 minutes

Study Arms (5)

Normal weight

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

Obese weight

BMI ≥ 95th percentile

PreDiabetes

HbA1c \> 5.7%

Type 2 Diabetes

Diagnosed with Type 2 Diabetes

Overweight

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

Eligibility Criteria

• Age: 14 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Insulin Resistance; Obesity; Metabolic Diseases; Prediabetic State

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kanakadurga Singer, MA, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

The Singer Lab Team

CONTACT

(734) 615-4938; MiMoStudy@med.umich.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 10, 2023
• First Posted: August 23, 2023
• Study Start: September 6, 2023
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: May 7, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Genotype/sequencing and phenotype data will be submitted after the genotyping/sequencing data have been cleaned. Following submission, data will be released within six months.
• Access Criteria: In regards to genomic data, individual-level data will be deidentified and made available through controlled-access.

Locations

US (1)