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

Primary Purpose

Obesity, Metabolic Syndrome X

Status

Completed

Phase

Not Applicable

Locations

Netherlands

Study Type

Interventional

Intervention

Intravenous infusion of Intralipid/heparin

Intravenous infusion of Glycerol/heparin

About this trial

This is an interventional educational/counseling/training trial for Obesity focused on measuring free fatty acids, vasodilation, sympathetic activity

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Healthy volunteers Exclusion Criteria: Pregnancy Asthma Use of medication Cardiovascular/pulmonary disease and diabetes

Sites / Locations

Radboud University Nijmegen Medical Centre

Outcomes

Primary Outcome Measures

Forearm blood flow

Vasoactive effect of caffeine

Sympathetic activity (noradrenaline spillover, spectral analysis)

Secondary Outcome Measures

Full Information

NCT ID

NCT00184899

First Posted

September 12, 2005

Last Updated

February 28, 2007

Sponsor

Radboud University Medical Center

Collaborators

ZonMw: The Netherlands Organisation for Health Research and Development

1. Study Identification

Unique Protocol Identification Number

NCT00184899

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2007

Overall Recruitment Status

Completed

Study Start Date

August 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

August 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Radboud University Medical Center

Collaborators

ZonMw: The Netherlands Organisation for Health Research and Development

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity, Metabolic Syndrome X

Keywords

free fatty acids, vasodilation, sympathetic activity

7. Study Design

Primary Purpose

Educational/Counseling/Training

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Single

Allocation

Randomized

Enrollment

20 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Intravenous infusion of Intralipid/heparin

Intervention Type

Drug

Intervention Name(s)

Intravenous infusion of Glycerol/heparin

Primary Outcome Measure Information:

Title

Forearm blood flow

Title

Vasoactive effect of caffeine

Title

Sympathetic activity (noradrenaline spillover, spectral analysis)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Healthy volunteers Exclusion Criteria: Pregnancy Asthma Use of medication Cardiovascular/pulmonary disease and diabetes

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Paul Smits, MD, PhD

Organizational Affiliation

Radboud University Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Radboud University Nijmegen Medical Centre

City

Nijmegen

ZIP/Postal Code

6500HB

Country

Netherlands

12. IPD Sharing Statement

Citations:

PubMed Identifier

11254897

Citation

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. doi: 10.1016/s0021-9150(00)00745-0.

Results Reference

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

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