Bioenergetics and Metabolism in Pediatric Populations

March 7, 2024 updated by: Arkansas Children's Hospital Research Institute
The investigators want to learn more about obesity, the development of insulin resistance, and Type 2 Diabetes in children. The investigators will do this through collecting information about children's health and conducting experiments on a variety of samples.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

175

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72202
        • Arkansas Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 17 years (Child)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Study investigators, research staff, or any qualified personnel will conduct recruitment of study participants using IRB approved advertisement. 175 pre-pubertal children ages 5-9 years old or children diagnosed with type 2 diabetes or insulin resistance ages 5-17 years old will be recruited and may enroll for this study with the goal that 130 subjects stratified across the study groups will complete the study.

Description

Inclusion Criteria:

  • Age 5-9 years and Tanner stage as reported by parent no greater than stage 1 OR Age 5 years - 17 years 5 months, diagnosed with type 2 diabetes mellitus or insulin resistance
  • Either healthy lean (BMI≥ 5th percentile and <85th percentile for age/sex) or obese (BMI ≥ 95th percentile for age/sex)
  • For those with BMI≥ 95th percentile for age/sex, parental verbal confirmation will be obtained that the child had a history of BMI≥ 95th percentile for age/sex for at least six months prior to study enrollment

Exclusion criteria:

  • Genetic or physical conditions impacting mobility over past year as determined by the Principal Investigator (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
  • BMI<5th percentile for age/sex (classified as underweight based on Centers for Disease Control and Prevention growth charts)
  • Subjects determined ineligible by the PI.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

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.
Healthy Obese
Healthy obese individuals (n=20) defined with a Body Mass Index (BMI) ≥ 95th percentile for age/sex will be recruited. Participants in this cohort will be asked to complete a one-time study visit.
Obese Insulin Resistant
Obese insulin resistant individuals (n=70) as defined with a Body Mass Index (BMI) ≥ 95th percentile for age/sex and will be recruited. Participants will be asked to complete a total of 2 study visits. The second study visit will occur at 12 months (± 2 weeks) after the initial study visit.
Type 2 Diabetes or Insulin Resistant
Obese individuals with Type 2 Diabetes or insulin resistance (n=20)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Altered circulating blood cell bioenergetics
Time Frame: After completion of all study visits, approximately 2 years.
The investigators hypothesize that when compared to normal weight or obese insulin sensitive children, obese insulin resistant children will exhibit altered circulating blood cell bioenergetics.
After completion of all study visits, approximately 2 years.
Oxidized plasma redox state
Time Frame: After completion of all study visits, approximately 2 years.
The investigators hypothesize that when compared to normal weight or obese insulin sensitive children, obese insulin resistant children will exhibit a more oxidized plasma redox state.
After completion of all study visits, approximately 2 years.
Alterations in resting energy expenditure
Time Frame: After completion of all study visits, approximately 2 years.
The investigators hypothesize that when compared to normal weight or obese insulin sensitive children, obese insulin resistant children will be associated with alterations of decreased resting energy expenditure.
After completion of all study visits, approximately 2 years.
Alterations in fatty acid oxidation
Time Frame: After completion of all study visits, approximately 2 years.
We hypothesize that when compared to normal weight or obese insulin sensitive children, obese insulin resistant children will be associated with alterations of impaired fatty acid oxidation (FAO).
After completion of all study visits, approximately 2 years.
Poor oxidative capacity
Time Frame: After completion of all study visits, approximately 2 years.
The investigators hypothesize that poor oxidative capacity over time may distinguish between metabolically healthy obese (MHO) and metabolically unhealthy obese (MUO) phenotypes.
After completion of all study visits, approximately 2 years.
Predicting Type 2 Diabetes development
Time Frame: After completion of all study visits, approximately 2 years.
The investigators hypothesize that poor oxidative capacity over time may be predictive of Type 2 Diabetes development.
After completion of all study visits, approximately 2 years.
Bioenergetics in Type 2 Diabetes with metformin
Time Frame: 6 months
The investigators hypothesize that the change in bioenergetics will be improved in obese Type 2 Diabetes children at 6 months of metformin therapy that will be prescribed as part of their clinical care.
6 months
Resting Energy Expenditure in Type 2 Diabetes with metformin
Time Frame: 6 months
The investigators hypothesize that the change in resting energy expenditure will be improved in obese Type 2 Diabetes children at 6 months of metformin therapy that will be prescribed as part of their clinical care.
6 months
Fatty Acid Oxidation in Type 2 Diabetes with metformin
Time Frame: 6 months
The investigators hypothesize that the change in fatty acid oxidation will be improved in obese Type 2 Diabetes children at 6 months of metformin therapy that will be prescribed as part of their clinical care.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arkansas Children's Hospital Research Institute

Collaborators

National Institutes of Health (NIH)
National Institute of General Medical Sciences (NIGMS)
University of Arkansas

Investigators

  • Study Chair: Shannon Rose, PhD, Arkansas Children's Research Institute
  • Principal Investigator: Eugenia Carvalho, PhD, Arkansas Children's Nutrition Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 18, 2017

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

September 27, 2017

First Submitted That Met QC Criteria

October 25, 2017

First Posted (Actual)

October 27, 2017

Study Record Updates

Last Update Posted (Actual)

March 8, 2024

Last Update Submitted That Met QC Criteria

March 7, 2024

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BMPP
  • 206164 (Other Identifier: UAMS IRB)
  • 1P20GM109096-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The information collected at the study visit, saliva, cheek swabs, blood, urine, and stool samples may be stored indefinitely and may be used for future research studies on pediatric nutrition. 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. 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 and study acronym to maintain confidentiality.

IPD Sharing 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.

IPD Sharing 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 and study acronym to maintain confidentiality.

IPD Sharing Supporting Information Type

  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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