Growth Hormone and Endothelial Function in Children



Status:Completed
Conditions:Endocrine, Endocrine
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:8 - 18
Updated:6/1/2018
Start Date:January 2005
End Date:December 2007

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Objective: This study is designed to determine whether growth hormone treatment in children 8
to 18 years of age alters function of the lining of the arteries. This may play a role in
increasing or decreasing the risk of heart disease.

Methods. Twenty children, for whom growth hormone therapy will be otherwise provided, will be
studied before and 3 months after starting growth hormone. Subjects can be on other hormonal
replacements but no other medications.

Each study will be done in the fasting state. The blood vessel function will be determined by
measuring the change in forearm blood flow before and after blocking flow to the arm for 5
minutes. Blood will be drawn after the test to measure glucose, insulin and fats.

The purpose of the research is to learn more about how the lining of arteries in the body
(called the endothelium) is affected by growth hormone treatment in children and adolescents.
Poor function by the blood vessels is associated with increased risk of heart disease or
stroke. This research is being done because growth hormone treatment has been shown to make
the endothelium work better in adults. Growth hormone treatment may have the same or
different effects in children because the dose is larger in children.

Children between 8 and 18 years who are to be started on growth hormone will be eligible to
participate. Blood vessel function will be studied before starting growth hormone and 3
months after. This will be done by measuring blood flow to the arm before and after 5 min of
stopping blood flow to the arm. The three months of growth hormone will be given free.

Inclusion Criteria:

- isolated growth hormone deficiency (peak growth hormone level less than 10 ng/ml in
response to arginine-insulin stimulation with cortisol responses and thyroid function
tests), panhypopituitarism with appropriate thyroxine (normal free T4 level) and
cortisol replacement (8-12 mg/m2/day) and non classic growth hormone deficiency
(growth velocity less than 5 cm/year; peak growth hormone >10 ng/ml).

Exclusion Criteria:

- Taking medications other than the appropriate hormonal replacement(L-thyroxine,
cortisol, estrogen or testosterone, DDAVP)
We found this trial at
1
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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