Sexually Dimorphic Effects of GHRH in Adult Growth Hormone Testing

Growth Hormone Deficiency Clinical Trial

Official title:

Sexually Dimorphic Effects of GHRH in Adult Growth Hormone Testing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00324064
• Other study ID #: 06 03-053
• Status: Completed
• Phase: N/A
• First received: May 8, 2006
• Last updated: March 3, 2010
• Start date: July 2007
• Est. completion date: July 2009

Study information

• Verified date: March 2010
• Source: Children's Mercy Hospital Kansas City
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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:

1. Confirm the sexual dimorphism in growth hormone responses for adult growth hormone testing in healthy male and female subjects

2. 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

3. Determine whether sexual dimorphism is acquired during puberty

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 5 Years to 40 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Dwarfism, Pituitary
• Endocrine System Diseases
• Growth Hormone Deficiency

Intervention

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.

Locations

Country	Name	City	State
United States	Children's Mercy Hospital	Kansas City	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Children's Mercy Hospital Kansas City

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum GH levels in response to GHRH/arginine stimulation		End of study	No
Secondary	mRNA and protein levels of G alpha q and G alpha S stimulatory proteins		end of study	No
Secondary	Serum gonadal steroid levels in the three subject groups		end of study	No