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Sponsored by: |
Children's Mercy Hospital Kansas City |
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Information provided by: | Children's Mercy Hospital Kansas City |
ClinicalTrials.gov Identifier: | NCT00324064 |
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 |
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Growth Hormone Deficiency |
Procedure: GHRH/arginine stimulation testing |
Study Type: | Interventional |
Study Design: | Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacodynamics Study |
Official Title: | Sexually Dimorphic Effects of GHRH in Adult Growth Hormone Testing |
Estimated Enrollment: | 90 |
Study Start Date: | July 2007 |
Estimated Study Completion Date: | July 2009 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
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:
Ages Eligible for Study: | 5 Years to 40 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Healthy subjects
GH subjects - Males and females, Tanner stage V, aged 15-21 years with a history of childhood growth hormone deficiency
Exclusion Criteria:
Healthy subjects
GH subjects
- Subjects with GH deficiency who have not discontinued GH treatment for at least 2 months
Contact: Mark Clements, MD | 816-234-1660 | mclements@cmh.edu |
United States, Missouri | |
Children's Mercy Hospital | Recruiting |
Kansas City, Missouri, United States, 64108 | |
Contact: Amy Fox 816-802-1208 arfox@cmh.edu | |
Principal Investigator: Jill Jacobson, MD | |
Sub-Investigator: Mark Clements, MD |
Principal Investigator: | Jill Jacobson, MD | Children's Mercy Hospital |
Responsible Party: | Children's Mercy Hospitals and Clinics ( Mark Clements ) |
Study ID Numbers: | 06 03-053 |
Study First Received: | May 8, 2006 |
Last Updated: | January 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00324064 |
Health Authority: | United States: Institutional Review Board |
Growth hormone deficiency |
Dwarfism Bone Diseases, Endocrine Hypopituitary dwarfism Hypothalamic Diseases Pituitary Diseases Endocrine System Diseases Central Nervous System Diseases Dwarfism, Pituitary |
Brain Diseases Bone Diseases Growth hormone deficiency Musculoskeletal Diseases Hypopituitarism Bone Diseases, Developmental Endocrinopathy Growth Hormone-Releasing Hormone |
Nervous System Diseases |