Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Peripheral Metabolic Effects of Ghrelin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00771940
Recruitment Status : Completed
First Posted : October 15, 2008
Last Update Posted : February 3, 2009
Sponsor:
Information provided by:
University of Aarhus

Tracking Information
First Submitted Date  ICMJE October 8, 2008
First Posted Date  ICMJE October 15, 2008
Last Update Posted Date February 3, 2009
Study Start Date  ICMJE October 2008
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 13, 2008)
Plasma levels of glucose [ Time Frame: During study day ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00771940 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 13, 2008)
  • Insulin signaling [ Time Frame: Study day ]
  • Serum levels of fatty acids [ Time Frame: Study day ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Peripheral Metabolic Effects of Ghrelin
Official Title  ICMJE Peripheral Metabolic Effects of Intra Arterial Ghrelin Infusion in Healthy Controls
Brief Summary The aim of this study is to investigate putative peripheral effects of ghrelin on glucose and lipid metabolism in healthy men. Eight subjects will be enrolled. The hypothesis is that ghrelin infusion causes insulin resistance and lipolysis.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Condition  ICMJE Healthy Controls
Intervention  ICMJE Drug: Ghrelin
Solvent, cont. infusion
Study Arms  ICMJE Active Comparator: Ghrelin
Intervention: Drug: Ghrelin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: October 13, 2008)
8
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2009
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. BMI < 27 kg/m2
  2. Written informed consent
  3. Non-smoker

Exclusion Criteria:

  1. Any disease including epilepsy
  2. Any use of medications (excl. paracetamol)
  3. Present or previous malignancy
  4. Alcohol dependency
  5. Allergy to any trial medication
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00771940
Other Study ID Numbers  ICMJE M-2007008
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jens Otto Lunde Jorgensen/MD Professor and Esben T. Vestergaard/MD PhD, Aarhus University Hospital
Study Sponsor  ICMJE University of Aarhus
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Jens Otto L. Jorgensen, MD Medical Department M, Aarhus University Horpital, Denmark
Principal Investigator: Esben T Vestergaard, PhD Medical Department M, Aarhus University Hospital, Denmark
PRS Account University of Aarhus
Verification Date February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP