ObesityIPONCT03960333
Immunometabolism in Pediatric Obesity
An observational study of Obesity and Type 2 Diabetes Mellitus, run by Arkansas Children's Hospital Research Institute at 1 site in United States.
Trial summary
This is a study to learn about obesity and how insulin resistance and Type 2 Diabetes develops in children. Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Obesity, Type 2 Diabetes Mellitus, Insulin Resistance
- How many people
- 82 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Apr 2019to 30 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 5 to 17 years
- All sexes
- Child
Study population: 110 children ages 5-17 years old will be recruited with the goal that approximately 80 subjects stratified across the following groups will complete the study: i) healthy lean (approximately n=20); ii) overweight/obese (approximately n=40, with the anticipation that approximately 20 of these children will be insulin resistant); iii) overweight/obese with T2D and prescribed Metformin (approximately n=20). Every attempt will be made to ensure that the desired number for each group is achieved and groups are balanced with respect to age, sex and ethnicity.
Who may be able to join
- Age 5-17 years, inclusive
- Either healthy lean (BMI≥ 5th percentile and <85th percentile for age/sex) or overweight (BMI ≥ 85th percentile and <95th) or obese (BMI ≥ 95th percentile for age/sex)
- For those with BMI≥ 85th percentile for age/sex, parental verbal confirmation that the child had a history of BMI≥ 85th percentile for age/sex for at least six months prior to study enrollment OR
- Age 5 years - 17 years 5 months, inclusive
- Either overweight or obese (BMI≥ 85th percentile for age/sex)
- Parental verbal confirmation that the child had a history of BMI≥ 85th percentile for age/sex for at least six months prior to study enrollment
- Diagnosed with type 2 diabetes mellitus or insulin resistance
- Prescribed metformin (either not yet taking or began taking within 3 weeks of enrollment)
Who cannot join
- Having an infection (viral, respiratory, gastrointestinal) in the previous 4 weeks
- Genetic or physical conditions impacting mobility over past year as determined by the PI
- Having known chronic illnesses/disorders that may independently affect study outcome measures: type 1 diabetes mellitus, neurologic (e.g. epilepsy), developmental (developmental delay, autism spectrum disorder), endocrine (thyroid, Cushing's), hepatic, autoimmune, cardiac and renal disorders. Also, chronic lung disorders except well controlled asthma that does not require permanent use of inhaled/oral steroids
- Taking any of the following medications that can affect study outcome: antipsychotics, thyroid hormone replacement therapy, inhaled/oral steroids, insulin, anabolic drugs (growth hormone replacement therapy and oxandrolone) and stimulants
- Taking metformin prescribed as part of their clinical care for longer than 3 weeks at the time of enrollment (may begin metformin therapy prescribed as part of their clinical care while enrolled in the study)
- BMI<5th percentile for age/sex (classified as underweight based on CDC growth charts)
- Subjects determined ineligible by the PI or delegated staff.
Trial locations and contacts
1 site in 1 country.
United States1 site
Arkansas Children's Research Institute
Little Rock, Arkansas, 72202
About this study
This is a study to learn about obesity and how insulin resistance and Type 2 Diabetes develops in children.
Read the detailed description
The main purpose of this proposed study is to determine whether the immunometabolic phenotypes of CD4+T cells from obese children is skewed towards Teff with mTOR-driven glycolysis and away from Tregs with AMPK-driven OXPHOS and whether metformin can reverse the immunometabolic phenotypes.
This study consists of:
- An observational cross sectional immune and metabolic analysis of several groups of children including lean, overweight/obese, and T2D.
- A prospective immune and metabolic analysis of newly diagnosed children with T2D or insulin resistance who will be or were recently prescribed metformin as part of their clinical care.
Children with T2D or insulin resistance who will be or were recently prescribed metformin, will be asked to complete two study visits. If completed, the second visit will occur 6 months (+/- 2 weeks) after beginning metformin as part of their clinical care. All other children, will be asked to complete only the first visit.
- Conditions
- Obesity, Type 2 Diabetes Mellitus, Insulin Resistance
- Keywords
- Obesity, Type2 Diabetes Mellitus, Type2 Diabetes, Insulin Resistance, Metformin, Pediatric Health
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2, Insulin Resistance
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 |
|---|---|---|
| Healthy Lean | Healthy lean individuals (n=20) defined with a Body Mass Index (BMI) ≥ 5th percentile and <85th percentile for age/sex will be recruited. Participants in this cohort will be asked to complete a one-time study visit. | |
| Overweight/Obese | Overweight/Obese individuals (n=20) defined with a Body Mass Index (BMI) ≥ 85th percentile for age/sex will be recruited. Participants in this cohort will be asked to complete a one-time study visit. | |
| Type 2 Diabetes or Insulin Resistant | Obese individuals with Type 2 Diabetes or insulin resistance who have been recently prescribed Metformin and have a Body Mass Index (BMI) ≥ 85th percentile for age/sex (n=20) will be recruited. Participants in this cohort will be asked to complete a two study visits approximately 6 months apart. |
What is being measured
The primary outcome is the main question the study is designed to answer.
circulating CD4+T cells in Overweight/Obese vs Lean
We will measure and report the percent of ATP derived from glycolysis and oxidative phosphorylation in circulating CD4+ T cells as well as the % CD4+CD25+CD127lowFoxP3+ cells (Tregs) in overweight/obese vs lean children.
Measured: After completion of all study visits, approximately 2 years.
circulating CD4+T cells in Type 2 Diabetic pre/post Metformin
We will measure and report the percent of ATP derived from glycolysis and oxidative phosphorylation in circulating CD4+ T cells as well as the % CD4+CD25+CD127lowFoxP3+ cells (Tregs) in Type 2 Diabetic children pre and post-Metformin treatment.
Measured: After completion of all study visits, approximately 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2019
- Study start25 Apr 2019
- Primary completion5 Feb 2021
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arkansas Children's Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of General Medical Sciences (NIGMS), University of Arkansas
- Responsible party
- Sponsor
- Investigators
- Shannon Rose, PhD, Principal investigator, Arkansas Children's Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03960333
- Sponsor's protocol ID
- 228816
- Other IDs
- P20GM109096
- Acronym
- IPO
- Status last verified
- Feb 2025
- First submitted
- 6 May 2019
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The information collected at the study visit, urine, and stool samples, and remaining blood samples may be stored indefinitely and may be used for future research studies on pediatric nutrition or metabolism. Prior to the information collected at the study visit and samples being used for future research studies, the PI will assess the ethics and scientific merit of the proposed research with the samples, and proposed future research will be reviewed by the IRB as may be required.
Publications
Rose S, Landes RD, Vyas KK, Delhey L, Blossom S. Regulatory T cells and bioenergetics of peripheral blood mononuclear cells linked to pediatric obesity. Immunometabolism (Cobham). 2024 Apr 25;6(2):e00040. doi: 10.1097/IN9.0000000000000040. eCollection 2024 Apr.
PubMed 38680993
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunometabolism in Pediatric Obesity
- ClinicalTrials.gov ID
- NCT03960333
- Acronym / sponsor ID
- IPO / 228816
- Conditions
- Obesity, Type 2 Diabetes Mellitus, Insulin Resistance
- Keywords
- Obesity, Type2 Diabetes Mellitus, Type2 Diabetes, Insulin Resistance, Metformin, Pediatric Health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Arkansas Children's Hospital Research InstituteUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of General Medical Sciences (NIGMS), University of Arkansas
- Study start
- 25 Apr 2019 (actual)
- Primary completion
- 5 Feb 2021 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 23 May 2019 (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 is a study to learn about obesity and how insulin resistance and Type 2 Diabetes develops in children.
Detailed description
The main purpose of this proposed study is to determine whether the immunometabolic phenotypes of CD4+T cells from obese children is skewed towards Teff with mTOR-driven glycolysis and away from Tregs with AMPK-driven OXPHOS and whether metformin can reverse the immunometabolic phenotypes.
This study consists of:
- An observational cross sectional immune and metabolic analysis of several groups of children including lean, overweight/obese, and T2D.
- A prospective immune and metabolic analysis of newly diagnosed children with T2D or insulin resistance who will be or were recently prescribed metformin as part of their clinical care.
Children with T2D or insulin resistance who will be or were recently prescribed metformin, will be asked to complete two study visits. If completed, the second visit will occur 6 months (+/- 2 weeks) after beginning metformin as part of their clinical care. All other children, will be asked to complete only the first visit.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy Lean | – | –Healthy lean individuals (n=20) defined with a Body Mass Index (BMI) ≥ 5th percentile and <85th percentile for age/sex will be recruited. Participants in this cohort will be asked to complete a one-time study visit. |
| Overweight/Obese | – | –Overweight/Obese individuals (n=20) defined with a Body Mass Index (BMI) ≥ 85th percentile for age/sex will be recruited. Participants in this cohort will be asked to complete a one-time study visit. |
| Type 2 Diabetes or Insulin Resistant | – | –Obese individuals with Type 2 Diabetes or insulin resistance who have been recently prescribed Metformin and have a Body Mass Index (BMI) ≥ 85th percentile for age/sex (n=20) will be recruited. Participants in this cohort will be asked to complete a two study visits approximately 6 months apart. |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Age groups
- Child
- Study population
- 110 children ages 5-17 years old will be recruited with the goal that approximately 80 subjects stratified across the following groups will complete the study: i) healthy lean (approximately n=20); ii) overweight/obese (approximately n=40, with the anticipation that approximately 20 of these children will be insulin resistant); iii) overweight/obese with T2D and prescribed Metformin (approximately n=20). Every attempt will be made to ensure that the desired number for each group is achieved and groups are balanced with respect to age, sex and ethnicity.
Key inclusion criteria (8 listed)
- Age 5-17 years, inclusive
- Either healthy lean (BMI≥ 5th percentile and <85th percentile for age/sex) or overweight (BMI ≥ 85th percentile and <95th) or obese (BMI ≥ 95th percentile for age/sex)
- For those with BMI≥ 85th percentile for age/sex, parental verbal confirmation that the child had a history of BMI≥ 85th percentile for age/sex for at least six months prior to study enrollment OR
- Age 5 years - 17 years 5 months, inclusive
- Either overweight or obese (BMI≥ 85th percentile for age/sex)
Key exclusion criteria (7 listed)
- Having an infection (viral, respiratory, gastrointestinal) in the previous 4 weeks
- Genetic or physical conditions impacting mobility over past year as determined by the PI
- Having known chronic illnesses/disorders that may independently affect study outcome measures: type 1 diabetes mellitus, neurologic (e.g. epilepsy), developmental (developmental delay, autism spectrum disorder), endocrine (thyroid, Cushing's), hepatic, autoimmune, cardiac and renal disorders. Also, chronic lung disorders except well controlled asthma that does not require permanent use of inhaled/oral steroids
- Taking any of the following medications that can affect study outcome: antipsychotics, thyroid hormone replacement therapy, inhaled/oral steroids, insulin, anabolic drugs (growth hormone replacement therapy and oxandrolone) and stimulants
- Taking metformin prescribed as part of their clinical care for longer than 3 weeks at the time of enrollment (may begin metformin therapy prescribed as part of their clinical care while enrolled in the study)
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
circulating CD4+T cells in Overweight/Obese vs Lean
Time frame: After completion of all study visits, approximately 2 years.
We will measure and report the percent of ATP derived from glycolysis and oxidative phosphorylation in circulating CD4+ T cells as well as the % CD4+CD25+CD127lowFoxP3+ cells (Tregs) in overweight/obese vs lean children.
circulating CD4+T cells in Type 2 Diabetic pre/post Metformin
Time frame: After completion of all study visits, approximately 2 years.
We will measure and report the percent of ATP derived from glycolysis and oxidative phosphorylation in circulating CD4+ T cells as well as the % CD4+CD25+CD127lowFoxP3+ cells (Tregs) in Type 2 Diabetic children pre and post-Metformin treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
- Results publication: PubMed 38680993Rose S, Landes RD, Vyas KK, Delhey L, Blossom S. Regulatory T cells and bioenergetics of peripheral blood mononuclear cells linked to pediatric obesity. Immunometabolism (Cobham). 2024 Apr 25;6(2):e00040. doi: 10.1097/IN9.0000000000000040. eCollection 2024 Apr.
- Individual participant dataSharing planned: Yes. The information collected at the study visit, urine, and stool samples, and remaining blood samples may be stored indefinitely and may be used for future research studies on pediatric nutrition or metabolism. Prior to the information collected at the study visit and samples being used for future research studies, the PI will assess the ethics and scientific merit of the proposed research with the samples, and proposed future research will be reviewed by the IRB as may be required.
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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. This study is not recruiting at the moment.
Shannon Rose, PhD principal investigator
Arkansas Children's Research Institute
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 Obesity and Type 2 Diabetes Mellitus, run by Arkansas Children's Hospital Research Institute 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 8 inclusion and 7 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: finished, as of the sponsor's last update on 13 Feb 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
circulating CD4+T cells in Overweight/Obese vs Lean (time frame: After completion of all study visits, approximately 2 years.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03960333, which also lists 1 linked publication.
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 13 Feb 2025.