Type 2 DiabetesNCT06007404
Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
An observational study of Type 2 Diabetes and Insulin Resistance, run by University of Michigan at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 14 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes, Insulin Resistance, Obesity
- How many people
- 175 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Sep 2023to Sep 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
About this study
Official title: The Role of Circulating Meta-Inflammatory Monocytes in Adolescent Insulin Resistance
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
- Medical subject headings
- Diabetes Mellitus, Type 2, Insulin Resistance, Obesity, Metabolic Diseases, Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 180 minutes
Secondary outcomes (2)
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
Measured: 180 minutes
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
Measured: 180 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study start6 Sep 2023
- Primary completionDec 2026 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 175 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kanakadurga Singer, University of Michigan
- Investigators
- Kanakadurga Singer, MA, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06007404
- Sponsor's protocol ID
- HUM00208301
- Other IDs
- R01DK130864
- Status last verified
- Jul 2026
- First submitted
- 10 Jun 2023
- Last updated
- 15 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Genomic and associated phenotypic data will be shared through NIH-designated data repositories.