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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00324064
Other study ID # 06 03-053
Secondary ID
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


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
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