Immunometabolism in Pediatric Obesity
IPO
2 other identifiers
observational
82
1 country
1
Brief Summary
This is a study to learn about obesity and how insulin resistance and Type 2 Diabetes develops in children.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2019
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 25, 2019
CompletedFirst Submitted
Initial submission to the registry
May 6, 2019
CompletedFirst Posted
Study publicly available on registry
May 23, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 5, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2024
CompletedFebruary 13, 2025
February 1, 2025
1.8 years
May 6, 2019
February 11, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
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.
After completion of all study visits, approximately 2 years.
Study Arms (3)
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.
Eligibility Criteria
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.
You may qualify if:
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Arkansas Children's Hospital Research Institutelead
- National Institutes of Health (NIH)collaborator
- National Institute of General Medical Sciences (NIGMS)collaborator
- University of Arkansascollaborator
Study Sites (1)
Arkansas Children's Research Institute
Little Rock, Arkansas, 72202, United States
Related Publications (1)
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.
PMID: 38680993RESULT
Biospecimen
Blood, urine, and stool samples may be retained. The blood sample will be used for bioenergetics, immunophenotyping, CD4+ T cell isolations, metabolic control pathway analysis, quantification of plasma CRP, pro-inflammatory, and anti-inflammatory cytokines and adipokines, and analyte analysis. The sample may be used for future research studies on pediatric nutrition. The urine and stool sample will be used for future research studies on pediatric nutrition.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shannon Rose, PhD
Arkansas Children's Research Institute
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 6, 2019
First Posted
May 23, 2019
Study Start
April 25, 2019
Primary Completion
February 5, 2021
Study Completion
June 30, 2024
Last Updated
February 13, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- CSR
- Time Frame
- The data and samples will be available after all data has been collected for the study and all samples have been processed for the study. 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 Institutional Review Board (IRB) as may be required.
- Access Criteria
- The samples and health information collected for the study visit may be shared with researchers at the University of Arkansas for Medical Sciences, Arkansas Children's Hospital, or Arkansas Children's Research Institute. The samples may be shared with an outside group. The samples will only have a study number, visit number, and study acronym to maintain confidentiality.
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.