Sexually Dimorphic Effects of GHRH in Adult Growth Hormone Testing - Full Text View

Sponsored by:	Children's Mercy Hospital Kansas City
Information provided by:	Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier:	NCT00324064

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

Genetics Home Reference related topics: pseudoachondroplasia

Drug Information available for: Somatotropin Somatropin Arginine Sermorelin Sermorelin acetate Arginine hydrochloride

U.S. FDA Resources

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

Further study details as provided by Children's Mercy Hospital Kansas City:

Primary Outcome Measures:

Serum GH levels in response to GHRH/arginine stimulation [ Time Frame: End of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

mRNA and protein levels of G alpha q and G alpha S stimulatory proteins [ Time Frame: end of study ] [ Designated as safety issue: No ]
Serum gonadal steroid levels in the three subject groups [ Time Frame: end of study ] [ Designated as safety issue: No ]

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)

Intervention Details:

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.

Detailed Description:

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
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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 Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00324064

Contacts

Contact: Mark Clements, MD

816-234-1660

mclements@cmh.edu

Locations

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

Sponsors and Collaborators

Children's Mercy Hospital Kansas City

Investigators

Principal Investigator:

Jill Jacobson, MD

Children's Mercy Hospital

More Information

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

Keywords provided by Children's Mercy Hospital Kansas City:

Growth hormone deficiency

Study placed in the following topic categories:

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

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009