- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03960333
Immunometabolism in Pediatric Obesity (IPO)
Study Overview
Status
Conditions
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Arkansas
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Little Rock, Arkansas, United States, 72202
- Arkansas Children's Research Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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.
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
circulating CD4+T cells in Overweight/Obese vs Lean
Time Frame: After completion of all study visits, approximately 2 years.
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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.
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After completion of all study visits, approximately 2 years.
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circulating CD4+T cells in Type 2 Diabetic pre/post Metformin
Time Frame: After completion of all study visits, approximately 2 years.
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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.
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After completion of all study visits, approximately 2 years.
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Shannon Rose, PhD, Arkansas Children's Research Institute
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 228816
- P20GM109096 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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