Growth Hormone and Endothelial Function in Children

Growth Hormone Deficiency Clinical Trial

Official title:

Growth Hormone and Endothelial Function in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00373386
• Other study ID #: Peds15
• Status: Completed
• Phase: Phase 4
• Start date: January 2005
• Est. completion date: December 2007

Study information

• Verified date: September 2017
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: December 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 18 Years

Eligibility

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)

Related Conditions & MeSH terms

• Dwarfism
• Dwarfism, Pituitary
• Growth Hormone Deficiency
• Panhypopituitarism
• Short Stature

Intervention

Drug:
• growth hormone
Growth Hormone treatment

Locations

Country	Name	City	State
United States	Ohio State University	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Ohio State University	Nationwide Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reactive Hyperemic Response After 3 Months of Growth Hormone	Forearm blood flow (FBF) was measured using strain gauge venous occlusion plethysmography using a Hokanson EC6 plethysmograph (DE Hokanson Inc, Bellevue, WA) in the left arm. With this technique sphygmomanometric cuffs were placed on the arm at the wrist and on the upper arm. During measurement the wrist cuff was inflated to 200 mmHg to occlude flow to the hand which is primarily skin blood flow and the upper arm cuff is inflated to 40 mmHG for 10 out of every 15 second to occlude venous return. FBF was obtained by measuring arm expansion with an indium-in-silastic strain gauge. Data was recorded using PowerLab and Chart 4.0 (AD Instruments, Grand Junction, CO) on a Power Mac G4 computer (Apple, Cupertino, CA).For each subject two minutes of baseline FBF were recorded and then the upper arm cuff was inflated to 200 mmHg pressure for five minutes to occlude flow to the arm. It was then released and forearm blood flow was measured for the next minute.	3 months
Secondary	Glucose	Plasma glucose	3 months
Secondary	Insulin	Plasma insulin	3 months
Secondary	HOMA	Insulin resistance	3 months
Secondary	Triglycerides	Plasma Triglycerides	3 months
Secondary	LDL	LDL level	3 months
Secondary	HDL	Plasma HDL	3 months