Sexually Dimorphic Effects of GHRH in Adult Growth Hormone Testing
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|ClinicalTrials.gov Identifier: NCT00324064|
Recruitment Status : Completed
First Posted : May 10, 2006
Last Update Posted : March 5, 2010
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
|Condition or disease||Intervention/treatment||Phase|
|Growth Hormone Deficiency||Procedure: GHRH/arginine stimulation testing||Not Applicable|
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:
- Confirm the sexual dimorphism in growth hormone responses for adult growth hormone testing in healthy male and female subjects
- 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
- Determine whether sexual dimorphism is acquired during puberty
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Sexually Dimorphic Effects of GHRH in Adult Growth Hormone Testing|
|Study Start Date :||July 2007|
|Actual Primary Completion Date :||July 2009|
|Actual Study Completion Date :||July 2009|
- Procedure: GHRH/arginine stimulation testing
GHRH(Geref) 1mcg/kg IVP followed by Arginine 10% solution 0.5mg/kg (maximum of 30 Gm) infused over 30 minutes. Labs drawn 6 times over 2 hours.
- Serum GH levels in response to GHRH/arginine stimulation [ Time Frame: End of study ]
- mRNA and protein levels of G alpha q and G alpha S stimulatory proteins [ Time Frame: end of study ]
- Serum gonadal steroid levels in the three subject groups [ Time Frame: end of study ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00324064
|United States, Missouri|
|Children's Mercy Hospital|
|Kansas City, Missouri, United States, 64108|
|Principal Investigator:||Jill Jacobson, MD||Children's Mercy Hospital Kansas City|