Sexually Dimorphic Effects of GHRH in Adult Growth Hormone Testing

March 3, 2010 updated by: Children's Mercy Hospital Kansas City

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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:

  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

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Children's Mercy Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 40 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Serum GH levels in response to GHRH/arginine stimulation
Time Frame: End of study
End of study

Secondary Outcome Measures

Outcome Measure
Time Frame
mRNA and protein levels of G alpha q and G alpha S stimulatory proteins
Time Frame: end of study
end of study
Serum gonadal steroid levels in the three subject groups
Time Frame: end of study
end of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Mercy Hospital Kansas City

Investigators

  • Principal Investigator: Jill Jacobson, MD, Children's Mercy Hospital Kansas City

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

May 8, 2006

First Submitted That Met QC Criteria

May 8, 2006

First Posted (Estimate)

May 10, 2006

Study Record Updates

Last Update Posted (Estimate)

March 5, 2010

Last Update Submitted That Met QC Criteria

March 3, 2010

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 06 03-053

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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