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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT02243852 -
Effects of Growth Hormone (GH) Deficiency and Growth Hormone Replacement on Serum Fibroblast Growth Factor 21 (FGF21)
|
N/A | |
Completed |
NCT01440686 -
Safety, Pharmacokinetics and Pharmacodynamics Study of HL-032 in Healthy Male Volunteers
|
Phase 1 | |
Completed |
NCT00990340 -
Comparison of a Needle-free Injection Method With a Needle-syringe Injection Method
|
Phase 4 | |
Completed |
NCT00149708 -
Consequence of Lifetime Isolated Growth Hormone Deficiency
|
N/A | |
Completed |
NCT00235599 -
The IGFBP-3 Stimulation Test: A New Tool for the Diagnosis of Growth Hormone Deficiency in Children.
|
N/A | |
Completed |
NCT00459940 -
The Effects of TZD on Fat Metabolism and Insulin Sensitivity in GH-Replaced GHD Patients
|
N/A | |
Completed |
NCT01157793 -
A Multicentre, Randomised, Open-label, Controlled Study to Evaluate the Effects of Saizen® on Cardiac Function in Growth Hormone Deficient(GHD) Subjects During the Transition Phase From Childhood to Adulthood
|
Phase 4 | |
Completed |
NCT00004365 -
Study of Pituitary Size and Function in Familial Dwarfism of Sindh
|
N/A | |
Recruiting |
NCT00227253 -
Chromosome 18 Clinical Research Center
|
||
Recruiting |
NCT04121780 -
Growth Hormone Replacement Therapy for Retried Professional Football Players
|
Phase 2 | |
Completed |
NCT02934399 -
Dynamic Hormone Diagnostics in Endocrine Disease
|
||
Completed |
NCT01090778 -
Diurnal Variation of Exogenous Peptides (GH Puls/Jurgita I)
|
Phase 2 | |
Completed |
NCT00965484 -
Genotropin Study Assessing Use of Injection Pen
|
Phase 3 | |
Completed |
NCT01062529 -
Peripheral Metabolic Effects of Somatostatin
|
N/A | |
Completed |
NCT00616278 -
National Cooperative Growth Study in CKD
|
N/A | |
Completed |
NCT02693522 -
Evaluation of Efficacy and Safety of Recombinant Somatroipn in Patients With Growth Hormone Deficiency
|
Phase 3 | |
Recruiting |
NCT02908958 -
Clinical Study of Pegylated Somatropin to Treat Children Growth Hormone Deficiency
|
Phase 4 | |
Terminated |
NCT01243892 -
A Study to Evaluate Growth in Participants Treated With Somatropin (Nutropin) Using NuSpin Device
|
N/A | |
Withdrawn |
NCT00638287 -
Inter-Assay Growth Hormone and IGF-I Variability
|
N/A | |
Completed |
NCT00957671 -
Anterior Pituitary Hormone Replacement in Traumatic Brain Injury
|
Phase 4 |