Clinical trial NCT03323294: Bioenergetics and Metabolism in Pediatric Populations
Official title: Bioenergetics and Metabolism in Pediatric Populations
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Type 2 Diabetes Mellitus
Insulin Resistance
Keywords: Obesity
Pediatric Health
Type 2 Diabetes
Insulin Resistance
Metformin Therapy
Lead sponsor: Arkansas Children's Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of General Medical Sciences (NIGMS)
name: University of Arkansas
First posted: 2017-10-27
Enrollment: 79
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Altered circulating blood cell bioenergetics
timeFrame: After completion of all study visits, approximately 2 years.
measure: Oxidized plasma redox state
timeFrame: After completion of all study visits, approximately 2 years.
measure: Alterations in resting energy expenditure
timeFrame: After completion of all study visits, approximately 2 years.
measure: Alterations in fatty acid oxidation
timeFrame: After completion of all study visits, approximately 2 years.
measure: Poor oxidative capacity
timeFrame: After completion of all study visits, approximately 2 years.
measure: Predicting Type 2 Diabetes development
timeFrame: After completion of all study visits, approximately 2 years.
measure: Bioenergetics in Type 2 Diabetes with metformin
timeFrame: 6 months
measure: Resting Energy Expenditure in Type 2 Diabetes with metformin
timeFrame: 6 months
measure: Fatty Acid Oxidation in Type 2 Diabetes with metformin
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Children's Hospital
state: Arkansas
Study officials:
affiliation: Arkansas Children's Research Institute
name: Shannon Rose, PhD
role: STUDY_CHAIR
affiliation: Arkansas Children's Nutrition Center
name: Eugenia Carvalho, PhD
role: PRINCIPAL_INVESTIGATOR
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