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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00184899
• Other study ID #: Intralipid-Ado
• Secondary ID: ZonMw Nr. 920-03
• Status: Completed
• Phase: N/A
• First received: September 12, 2005
• Last updated: February 28, 2007
• Start date: August 2005
• Est. completion date: August 2006

Study information

• Verified date: February 2007
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Healthy volunteers

Exclusion Criteria:

• Pregnancy

• Asthma

• Use of medication

• Cardiovascular/pulmonary disease and diabetes

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Single Blind, Primary Purpose: Educational/Counseling/Training

Related Conditions & MeSH terms

• Metabolic Syndrome X
• Obesity

Intervention

Drug:
• Intravenous infusion of Intralipid/heparin

• Intravenous infusion of Glycerol/heparin

Locations

Country	Name	City	State
Netherlands	Radboud University Nijmegen Medical Centre	Nijmegen

Sponsors (2)

Lead Sponsor	Collaborator
Radboud University	ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Forearm blood flow
Primary	Vasoactive effect of caffeine
Primary	Sympathetic activity (noradrenaline spillover, spectral analysis)