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Completed

NCT Number: NCT00324064

Sexually Dimorphic Effects of GHRH in Adult Growth Hormone Testing

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

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Key information

Age range

5 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GHRH/arginine stimulation testing

Procedure

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.

Primary outcomes

  1. Serum GH levels in response to GHRH/arginine stimulation

    Time frame: End of study

Secondary outcomes

  1. mRNA and protein levels of G alpha q and G alpha S stimulatory proteins

    Time frame: end of study

  2. Serum gonadal steroid levels in the three subject groups

    Time frame: end of study

Sponsors and collaborators

Lead sponsor

Children's Mercy Hospital Kansas City

Other

Registry information

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
May 10, 2006
Registry last updated
Mar 5, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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