Ghrelin, Growth Hormone and Cortisol Interaction in Growth Hormone Deficient Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00139945
Recruitment Status : Completed
First Posted : August 31, 2005
Last Update Posted : January 20, 2010
Information provided by:
University of Aarhus

Brief Summary:
In growth hormone deficient patients: Determination of endogenous circulating ghrelin levels, ghrelin effects on insulin sensitivity, appetite, energy metabolism, and signal transduction in fat and muscle.

Condition or disease Intervention/treatment Phase
Hypopituitarism Drug: Human acylated ghrelin Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Acute Ghrelin Infusion to Growth Hormone Deficient Adults: Growth Hormone and Cortisol Interaction
Study Start Date : October 2005
Actual Primary Completion Date : March 2007
Actual Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones
U.S. FDA Resources

Intervention Details:
    Drug: Human acylated ghrelin
    5 pmol/kg body weight per min

Primary Outcome Measures :
  1. Endogenous serum ghrelin levels [ Time Frame: Same day as intervention ]

Secondary Outcome Measures :
  1. Insulin sensitivity, appetite, metabolism, intracellular signal transduction [ Time Frame: Same day as intervention ]

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age between 18 and 60 yrs.
  • Verified hypopituitarism
  • Unchanged substitution treatment through 3+ months
  • Unchanged additional medical treatment
  • Oral and written informed consent

Exclusion Criteria:

  • Age below 18 or above 60 yrs.
  • Diabetes mellitus
  • body mass index > 30
  • Fasting hypoglycemia
  • Convulsions
  • Allergy to trial products

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00139945

Aarhus University Hospital
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Principal Investigator: Jens Otto L Jorgensen, DrMedSci Aarhus University Hospital

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Esben T. Vestergaard/MD PhD, University of Aarhus Identifier: NCT00139945     History of Changes
Other Study ID Numbers: 2004/102
First Posted: August 31, 2005    Key Record Dates
Last Update Posted: January 20, 2010
Last Verified: January 2010

Additional relevant MeSH terms:
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Inflammatory Agents