Bioenergetics and Metabolism in Pediatric Populations

NCT03323294 | Completed

• 3 other identifiers: BMPP2061641P20GM109096-01A1
• Study Type: observational
• Target: 79
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity; Type 2 Diabetes Mellitus; Insulin Resistance

Keywords

Obesity; Pediatric Health; Type 2 Diabetes; Insulin Resistance; Metformin Therapy

Outcome Measures

Primary Outcomes (9)

• Altered circulating blood cell bioenergetics

  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

  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

  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

  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

  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

  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

  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

  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

  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

Study Arms (4)

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)

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Arkansas Children's Hospital Research Institute: lead
• National Institutes of Health (NIH): collaborator
• National Institute of General Medical Sciences (NIGMS): collaborator
• University of Arkansas: collaborator

Study Sites (1)

Arkansas Children's Hospital

Little Rock, Arkansas, 72202, United States

Location

Related Publications (38)

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Biospecimen

Retention: SAMPLES WITH DNA

Blood, urine, stool, spit, and cheek cell samples may be retained. The blood sample will be used for bioenergetics and analyte analysis. The sample may be used for future research studies on pediatric nutrition. Urine samples will be collected to measure fat oxidation. The saliva, cheek swab, and stool sample will be used for future research studies on pediatric nutrition.

MeSH Terms

Conditions

Obesity; Diabetes Mellitus, Type 2; Insulin Resistance

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Study Officials

• Shannon Rose, PhD

  Arkansas Children's Research Institute

  STUDY CHAIR

• Eugenia Carvalho, PhD

  Arkansas Children's Nutrition Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2017
• First Posted: October 27, 2017
• Study Start: October 18, 2017
• Primary Completion: March 6, 2020
• 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 and study acronym to maintain confidentiality.

Locations

US (1)