Growth Hormone Deficiency Clinical Trial
Official title:
Growth Hormone and Endothelial Function in Children
NCT number | NCT00373386 |
Other study ID # | Peds15 |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | January 2005 |
Est. completion date | December 2007 |
Verified date | September 2017 |
Source | Ohio State University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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) |
Country | Name | City | State |
---|---|---|---|
United States | Ohio State University | Columbus | Ohio |
Lead Sponsor | Collaborator |
---|---|
Ohio State University | Nationwide Children's Hospital |
United States,
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 |
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