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

This study has been completed.
Information provided by:
University of Aarhus Identifier:
First received: August 30, 2005
Last updated: January 19, 2010
Last verified: January 2010
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 Intervention
Drug: Human acylated ghrelin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Acute Ghrelin Infusion to Growth Hormone Deficient Adults: Growth Hormone and Cortisol Interaction

Resource links provided by NLM:

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Endogenous serum ghrelin levels [ Time Frame: Same day as intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Insulin sensitivity, appetite, metabolism, intracellular signal transduction [ Time Frame: Same day as intervention ] [ Designated as safety issue: No ]

Enrollment: 8
Study Start Date: October 2005
Study Completion Date: March 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Human acylated ghrelin
    5 pmol/kg body weight per min

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
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Please refer to this study by its identifier: NCT00139945

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

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 
Study First Received: August 30, 2005
Last Updated: January 19, 2010
Health Authority: Denmark: Danish Medicines Agency

Additional relevant MeSH terms:
Brain Diseases
Central Nervous System Diseases
Endocrine System Diseases
Hypothalamic Diseases
Nervous System Diseases
Pituitary Diseases processed this record on May 03, 2016