Bioenergetics and Metabolism in Pediatric Populations



Status:Recruiting
Conditions:Obesity Weight Loss, Endocrine, Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:5 - 17
Updated:4/17/2018
Start Date:October 18, 2017
End Date:October 2019
Contact:Leanna Delhey, MPH
Email:delheylm@archildrens.org
Phone:501-364-4519

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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.


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 and prescribed Metformin (not yet taking)

- 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

- Taking metformin prescribed as part of their clinical care 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 Centers for Disease
Control and Prevention growth charts)

- Subjects determined ineligible by the PI.
We found this trial at
1
site
1 Children's Way
Little Rock, Arkansas 72202
(501) 364-1100
Principal Investigator: Eugenia Carvalho, PhD
Phone: 501-364-4519
Arkansas Children's Hospital Arkansas Children's Hospital (ACH) is the only pediatric medical center in Arkansas...
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mi
from
Little Rock, AR
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