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

This study is ongoing, but not recruiting participants.

First Received: August 30, 2005 Last Updated: July 9, 2008 History of Changes

Sponsored by:	University of Aarhus
Information provided by:	University of Aarhus
ClinicalTrials.gov Identifier:	NCT00139945

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

Drug Information available for: Somatropin Ghrelin Somatotropin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Pharmacokinetics/Dynamics Study
Official Title:	Effects of Acute Ghrelin Infusion to Growth Hormone Deficient Adults: Growth Hormone and Cortisol Interaction

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
Estimated Study Completion Date:	March 2007
Primary Completion Date:	March 2007 (Final data collection date for primary outcome measure)

Intervention Details:

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

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 National Clinical Trials Identifier (NCT ID):

Vestergaard ET, Gormsen LC, Jessen N, Lund S, Hansen TK, Moller N, Jorgensen JO. Ghrelin infusion in humans induces acute insulin resistance and lipolysis independent of growth hormone signaling. Diabetes. 2008 Dec;57(12):3205-10. Epub 2008 Sep 5.

Responsible Party:	University of Aarhus ( Esben T. Vestergaard/MD PhD )
Study ID Numbers:	2004/102
Study First Received:	August 30, 2005
Last Updated:	July 9, 2008
ClinicalTrials.gov Identifier:	NCT00139945 History of Changes
Health Authority:	Denmark: Danish Medicines Agency

Study placed in the following topic categories:

Hypothalamic Diseases
Hydrocortisone
Pituitary Diseases
Cortisol succinate
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Central Nervous System Diseases

Endocrine System Diseases
Brain Diseases
Hormones
Hypopituitarism
Endocrinopathy
Hydrocortisone acetate

Additional relevant MeSH terms:

Hypothalamic Diseases
Pituitary Diseases
Hypopituitarism
Physiological Effects of Drugs
Nervous System Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists

Endocrine System Diseases
Central Nervous System Diseases
Brain Diseases
Hormones
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009