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Immunometabolism in Pediatric Obesity (IPO)

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ClinicalTrials.gov Identifier: NCT03960333
Recruitment Status : Recruiting
First Posted : May 23, 2019
Last Update Posted : May 23, 2019
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of General Medical Sciences (NIGMS)
University of Arkansas
Information provided by (Responsible Party):
Arkansas Children's Hospital Research Institute

Brief Summary:
This is a study to learn about obesity and how insulin resistance and Type 2 Diabetes develops in children.

Condition or disease
Obesity Type 2 Diabetes Mellitus Insulin Resistance

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:

  1. An observational cross sectional immune and metabolic analysis of several groups of children including lean, overweight/obese, and T2D.
  2. 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.


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Study Type : Observational
Estimated Enrollment : 110 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Immunometabolism in Pediatric Obesity
Actual Study Start Date : April 25, 2019
Estimated Primary Completion Date : February 28, 2021
Estimated Study Completion Date : February 28, 2021

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. 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.

  2. 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.


Biospecimen Retention:   Samples Without DNA
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.


Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03960333


Contacts
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Contact: Leanna M Delhey, MPH 501-364-4519 DelheyLM@archildrens.org
Contact: Annette Guy, RN 501-364-3380 GuyEA@archildrens.org

Locations
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United States, Arkansas
Arkansas Children's Research Institute Recruiting
Little Rock, Arkansas, United States, 72202
Contact: Leanna M Delhey, MPH    501-364-4519    DelheyLM@archildrens.org   
Contact: Annette Guy, RN    501-364-3380    GuyEA@archildrens.org   
Principal Investigator: Shannon Rose, PhD         
Sub-Investigator: Jon Oden, MD         
Sub-Investigator: Emir Tas, MD         
Sub-Investigator: Shipra Bansal, MD         
Sub-Investigator: Vildan Tas, MD         
Sponsors and Collaborators
Arkansas Children's Hospital Research Institute
National Institutes of Health (NIH)
National Institute of General Medical Sciences (NIGMS)
University of Arkansas
Investigators
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Principal Investigator: Shannon Rose, PhD Arkansas Children's Research Institute
  Study Documents (Full-Text)

Documents provided by Arkansas Children's Hospital Research Institute:
Informed Consent Form  [PDF] January 18, 2019


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Responsible Party: Arkansas Children's Hospital Research Institute
ClinicalTrials.gov Identifier: NCT03960333     History of Changes
Other Study ID Numbers: 228816
P20GM109096 ( U.S. NIH Grant/Contract )
First Posted: May 23, 2019    Key Record Dates
Last Update Posted: May 23, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Clinical Study Report (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Arkansas Children's Hospital Research Institute:
Obesity
Type2 Diabetes Mellitus
Type2 Diabetes
Insulin Resistance
Metformin
Pediatric Health
Additional relevant MeSH terms:
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Obesity
Pediatric Obesity
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Nutrition Disorders
Diabetes Mellitus
Diabetes Mellitus, Type 2
Insulin Resistance
Overnutrition
Overweight
Body Weight
Signs and Symptoms
Hyperinsulinism
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs