Ghrelin, Growth Hormone and Cortisol Interaction in Growth Hormone Deficient Patients
This study has been completed.
Sponsor:
University of Aarhus
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00139945
First received: August 30, 2005
Last updated: January 19, 2010
Last verified: January 2010
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | August 30, 2005 | ||||
| Last Updated Date | January 19, 2010 | ||||
| Start Date ICMJE | October 2005 | ||||
| Primary Completion Date | March 2007 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Endogenous serum ghrelin levels [ Time Frame: Same day as intervention ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Endogenous serum ghrelin levels | ||||
| Change History | Complete list of historical versions of study NCT00139945 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Insulin sensitivity, appetite, metabolism, intracellular signal transduction [ Time Frame: Same day as intervention ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
Insulin sensitivity, appetite, metabolism, intracellular signal transduction | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Ghrelin, Growth Hormone and Cortisol Interaction in Growth Hormone Deficient Patients | ||||
| Official Title ICMJE | Effects of Acute Ghrelin Infusion to Growth Hormone Deficient Adults: Growth Hormone and Cortisol Interaction | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Hypopituitarism | ||||
| Intervention ICMJE | Drug: Human acylated ghrelin
5 pmol/kg body weight per min |
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| Study Arm (s) | Not Provided | ||||
| Publications * | 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. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 8 | ||||
| Completion Date | March 2007 | ||||
| Primary Completion Date | March 2007 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 60 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Denmark | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00139945 | ||||
| Other Study ID Numbers ICMJE | 2004/102 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Esben T. Vestergaard/MD PhD, University of Aarhus | ||||
| Study Sponsor ICMJE | University of Aarhus | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University of Aarhus | ||||
| Verification Date | January 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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