Growth Hormone Deficiency Clinical Trial
Official title:
Sexually Dimorphic Effects of GHRH in Adult Growth Hormone Testing
Specific Aim 1 Healthy male and female subjects and growth hormone (GH) deficient subjects
display sexually dimorphic GH responses to GHRH administration
Specific Aim 2 GH responses to GHRH in both healthy controls and in GH deficient patients
correlate with expression and activity of the stimulatory G proteins, G alpha q and G alpha
S. G protein levels correlate with gonadal steroid levels.
Specific Aim 3 Sexually dimorphic GH responses to GHRH are enhanced in Tanner Stage V
compared to Tanner Stage 1 individuals
Growth hormone deficiency affects disproportionately more males than females. Although
ascertainment bias plays a role in this sexual dimorphism, no plausible mechanism to fully
explain this difference has been proposed.
This investigator initiated study will provide currently unavailable data on sexual/age
differences in response to GH stimulation testing. Data obtained from the study may provide
a basis for developing appropriate normal ranges for adult GH testing, may provide a
plausible mechanism for the enhanced hormone responsiveness observed in females, and may
provide data on when the sexual differences to GH stimulation may develop.
The objectives of this study are to:
1. Confirm the sexual dimorphism in growth hormone responses for adult growth hormone
testing in healthy male and female subjects
2. Correlate peak Growth Hormone Releasing Hormone (GHRH)/arginine induced growth hormone
responses with G protein levels in healthy subjects and in patients with a history of
childhood GH deficiency
3. Determine whether sexual dimorphism is acquired during puberty
;
Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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 |
NCT00235599 -
The IGFBP-3 Stimulation Test: A New Tool for the Diagnosis of Growth Hormone Deficiency in Children.
|
N/A | |
Completed |
NCT00149708 -
Consequence of Lifetime Isolated Growth Hormone Deficiency
|
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 |
NCT01062529 -
Peripheral Metabolic Effects of Somatostatin
|
N/A | |
Completed |
NCT00965484 -
Genotropin Study Assessing Use of Injection Pen
|
Phase 3 | |
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 |
NCT00929799 -
Growth Hormone and Glucose Metabolism
|
Phase 4 |