Back to resultsGhrelin, Growth Hormone and Cortisol Interaction in Growth Hormone Deficient Patients
Primary Purpose
Hypopituitarism
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Human acylated ghrelin
Sponsored by
About this trial
This is an interventional treatment trial for Hypopituitarism
Eligibility 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
Sites / Locations
- Aarhus University Hospital
Outcomes
Primary Outcome Measures
Endogenous serum ghrelin levels
Secondary Outcome Measures
Insulin sensitivity, appetite, metabolism, intracellular signal transduction
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00139945
Brief Title
Ghrelin, Growth Hormone and Cortisol Interaction in Growth Hormone Deficient Patients
Official Title
Effects of Acute Ghrelin Infusion to Growth Hormone Deficient Adults: Growth Hormone and Cortisol Interaction
Study Type
Interventional
2. Study Status
Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
March 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Aarhus
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypopituitarism
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Human acylated ghrelin
Intervention Description
5 pmol/kg body weight per min
Primary Outcome Measure Information:
Title
Endogenous serum ghrelin levels
Time Frame
Same day as intervention
Secondary Outcome Measure Information:
Title
Insulin sensitivity, appetite, metabolism, intracellular signal transduction
Time Frame
Same day as intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens Otto L Jorgensen, DrMedSci
Organizational Affiliation
Aarhus University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
32975853
Citation
Lauritzen ES, Jorgensen JOL, Moller N, Nielsen S, Vestergaard ET. Increased lipolysis after infusion of acylated ghrelin: a randomized, double-blinded placebo-controlled trial in hypopituitary patients. Clin Endocrinol (Oxf). 2020 Dec;93(6):672-677. doi: 10.1111/cen.14290. Epub 2020 Aug 3.
Results Reference
derived
PubMed Identifier
18776138
Citation
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. doi: 10.2337/db08-0025. Epub 2008 Sep 5.
Results Reference
derived
Learn more about this trial
Ghrelin, Growth Hormone and Cortisol Interaction in Growth Hormone Deficient Patients
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