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
Status | Completed |
Enrollment | 90 |
Est. completion date | July 2009 |
Est. primary completion date | July 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 5 Years to 40 Years |
Eligibility |
Inclusion Criteria: Healthy subjects - Males and females, Tanner stage V aged 15-40 years of age with no known endocrine problems - Males and females, Tanner stage I, aged 5-8 years with no known endocrine problems GH subjects - Males and females, Tanner stage V, aged 15-21 years with a history of childhood growth hormone deficiency Exclusion Criteria: Healthy subjects - History of GH deficiency or treatment or other known endocrine disorder - Current height or adult height <5th % - Female subjects using hormonal methods of birth control - Female subjects with irregular menstrual cycles GH subjects - Subjects with GH deficiency who have not discontinued GH treatment for at least 2 months |
Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
United States | Children's Mercy Hospital | Kansas City | Missouri |
Lead Sponsor | Collaborator |
---|---|
Children's Mercy Hospital Kansas City |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Serum GH levels in response to GHRH/arginine stimulation | End of study | No | |
Secondary | mRNA and protein levels of G alpha q and G alpha S stimulatory proteins | end of study | No | |
Secondary | Serum gonadal steroid levels in the three subject groups | end of study | No |
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