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Sexually Dimorphic Effects of GHRH in Adult Growth Hormone Testing

This study has been completed.
Sponsor:
Information provided by:
Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier:
NCT00324064
First received: May 8, 2006
Last updated: March 3, 2010
Last verified: March 2010
  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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Sexually Dimorphic Effects of GHRH in Adult Growth Hormone Testing

Resource links provided by NLM:


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
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Missouri
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
Sponsors and Collaborators
Children's Mercy Hospital Kansas City
Investigators
Principal Investigator: Jill Jacobson, MD Children's Mercy Hospital
  More Information

No publications provided

Responsible Party: Mark Clements, Children's Mercy Hospitals and Clinics
ClinicalTrials.gov Identifier: NCT00324064     History of Changes
Other Study ID Numbers: 06 03-053
Study First Received: May 8, 2006
Last Updated: March 3, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Mercy Hospital Kansas City:
Growth hormone deficiency

Additional relevant MeSH terms:
Dwarfism, Pituitary
Endocrine System Diseases
Bone Diseases
Bone Diseases, Developmental
Bone Diseases, Endocrine
Brain Diseases
Central Nervous System Diseases
Dwarfism
Hypopituitarism
Hypothalamic Diseases
Musculoskeletal Diseases
Nervous System Diseases
Pituitary Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 27, 2014