Bioenergetics and Metabolism in Pediatric Populations

Arkansas Children's Hospital Research Institute

Status: Completed

Conditions: Type 2 Diabetes Mellitus; Insulin Resistance; Obesity

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT03323294

1P20GM109096-01A1 (U.S. NIH Grant/Contract)

206164 (Other Identifier)

BMPP

Details and patient eligibility

About

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.

Enrollment: 79 patients

Sex: All

Ages: 5 to 17 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

79 participants in 4 patient groups

Healthy Lean

Description:

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

Description:

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

Description:

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

Description:

Obese individuals with Type 2 Diabetes or insulin resistance (n=20)