Sexually Dimorphic Effects of GHRH in Adult Growth Hormone Testing
1 other identifier
interventional
90
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2007
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 8, 2006
CompletedFirst Posted
Study publicly available on registry
May 10, 2006
CompletedStudy Start
First participant enrolled
July 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2009
CompletedMarch 5, 2010
March 1, 2010
2 years
May 8, 2006
March 3, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Serum GH levels in response to GHRH/arginine stimulation
End of study
Secondary Outcomes (2)
mRNA and protein levels of G alpha q and G alpha S stimulatory proteins
end of study
Serum gonadal steroid levels in the three subject groups
end of study
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Children's Mercy Hospital
Kansas City, Missouri, 64108, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jill Jacobson, MD
Children's Mercy Hospital Kansas City
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 8, 2006
First Posted
May 10, 2006
Study Start
July 1, 2007
Primary Completion
July 1, 2009
Study Completion
July 1, 2009
Last Updated
March 5, 2010
Record last verified: 2010-03