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
- Are there results?
- Not yet: the study is under way
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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Circulating Meta-Inflammatory Monocytes in Adolescent Insulin Resistance
- ClinicalTrials.gov ID
- NCT06007404
- Acronym / sponsor ID
- HUM00208301
- Conditions
- Type 2 Diabetes, Insulin Resistance, Obesity, Metabolic Disease, PreDiabetes
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 175 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 6 Sep 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 23 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Glucose (OGTT)
Time frame: 120 minutes
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
Insulin (OGTT)
Time frame: 120 minutes
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
Glucose (MMTT)
Time frame: 180 minutes
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.
Insulin (MMTT)
Time frame: 180 minutes
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.
Monocyte /macrophage populations by flow cytometry
Time frame: 180 minutes
Frequencies by flow cytometry. Measurements will be taken at baseline sample and 180 minutes after consumption of high fat shake
2 secondary outcomes
Free fatty acids (MMTT)
Time frame: 180 minutes
Triglycerides (MMTT)
Time frame: 180 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: Yes. Genomic and associated phenotypic data will be shared through NIH-designated data repositories.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kanakadurga Singer, MA, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes and Insulin Resistance, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact The Singer Lab Team ((734) 615-4938, MiMoStudy@med.umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glucose (OGTT) (time frame: 120 minutes). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.