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Sexually Dimorphic Effects of GHRH in Adult Growth Hormone Testing
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Purpose
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 | Intervention |
|---|---|
| Growth Hormone Deficiency | Procedure: GHRH/arginine stimulation testing |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Diagnostic |
| Official Title: | Sexually Dimorphic Effects of GHRH in Adult Growth Hormone Testing |
- 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 ]
| Estimated Enrollment: | 90 |
| Study Start Date: | July 2007 |
| Study Completion Date: | July 2009 |
| Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
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Procedure: GHRH/arginine stimulation testing
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
Eligibility| Ages Eligible for Study: | 5 Years to 40 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00324064
| United States, Missouri | |
| Children's Mercy Hospital | |
| Kansas City, Missouri, United States, 64108 | |
| Principal Investigator: | Jill Jacobson, MD | Children's Mercy Hospital |
More Information
| Responsible Party: | Mark Clements, Children's Mercy Hospitals and Clinics |
| ClinicalTrials.gov Identifier: | NCT00324064 History of Changes |
| Other Study ID Numbers: |
06 03-053 |
| Study First Received: | May 8, 2006 |
| Last Updated: | March 3, 2010 |
Keywords provided by Children's Mercy Hospital Kansas City:
|
Growth hormone deficiency |
Additional relevant MeSH terms:
|
Endocrine System Diseases Dwarfism, Pituitary Dwarfism Bone Diseases, Developmental Bone Diseases Musculoskeletal Diseases Bone Diseases, Endocrine Hypopituitarism |
Pituitary Diseases Hypothalamic Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on August 17, 2017