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Trial record 93 of 1239 for:    Adenosine

The Potential Role for Adenosine in the Haemodynamic Effects of Free Fatty Acids

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: NCT00184899
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : March 1, 2007
Sponsor:
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by:
Radboud University

Tracking Information
First Submitted Date  ICMJE September 12, 2005
First Posted Date  ICMJE September 16, 2005
Last Update Posted Date March 1, 2007
Study Start Date  ICMJE August 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: March 31, 2006)
  • Forearm blood flow
  • Vasoactive effect of caffeine
  • Sympathetic activity (noradrenaline spillover, spectral analysis)
Original Primary Outcome Measures  ICMJE
 (submitted: September 12, 2005)
  • Forearm blood flow
  • Vaso-active effect of coffeine
  • Sympathetic activity (noradrenaline spillover, spectral analysis)
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Potential Role for Adenosine in the Haemodynamic Effects of Free Fatty Acids
Official Title  ICMJE The Potential Role for Adenosine in the Haemodynamic Effects of Free Fatty Acids
Brief Summary

The metabolic syndrome is associated with hyperdynamic circulation and sympathetic activation. Recently, Bakker et al. (Atherosclerosis 2002) described the hypothesis that free fatty acids are responsible for this association. The investigators hypothesize that in patients with obesity and the metabolic syndrome, an increased intracellular concentration of long-chain fatty acyl (LCFA)-CoA (the intracellular equivalent of free fatty acids) induces an increase in adenosine. Adenosine receptor stimulation, in turn, induces vasodilation and sympathetic activation.

The investigators aimed to assess this effect of free fatty acids on the adenosine system in healthy volunteers.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single
Primary Purpose: Educational/Counseling/Training
Condition  ICMJE
  • Obesity
  • Metabolic Syndrome X
Intervention  ICMJE
  • Drug: Intravenous infusion of Intralipid/heparin
  • Drug: Intravenous infusion of Glycerol/heparin
Study Arms  ICMJE Not Provided
Publications * Bakker SJ, Gans RO, ter Maaten JC, Teerlink T, Westerhoff HV, Heine RJ. The potential role of adenosine in the pathophysiology of the insulin resistance syndrome. Atherosclerosis. 2001 Apr;155(2):283-90.

*   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
Enrollment  ICMJE
 (submitted: September 12, 2005)
20
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE August 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy volunteers

Exclusion Criteria:

  • Pregnancy
  • Asthma
  • Use of medication
  • Cardiovascular/pulmonary disease and diabetes
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00184899
Other Study ID Numbers  ICMJE Intralipid-Ado
ZonMw Nr. 920-03-249
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Radboud University
Collaborators  ICMJE ZonMw: The Netherlands Organisation for Health Research and Development
Investigators  ICMJE
Principal Investigator: Paul Smits, MD, PhD Radboud University
PRS Account Radboud University
Verification Date February 2007

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