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

This study has been completed.
Sponsor:
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00139945
First received: August 30, 2005
Last updated: January 19, 2010
Last verified: January 2010
  Purpose

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
Hypopituitarism
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
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00139945

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

No publications provided by University of Aarhus

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Esben T. Vestergaard/MD PhD, University of Aarhus
ClinicalTrials.gov 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:
Hypopituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Hormones
Hydrocortisone
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 18, 2014