The Potential Role for Adenosine in the Haemodynamic Effe... | NCT00184899

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

NCT00184899

Sponsor

Radboud University Medical Center

Status

Completed

Last Update Posted

Mar 1, 2007Estimated

Enrollment

Phase

Not Applicable

Conditions

Obesity
Metabolic Syndrome X

Interventions

Intravenous infusion of Intralipid/heparin
Intravenous infusion of Glycerol/heparin

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
ZonMw Nr. 920-03-249

Status Module

Record Verification Date

Feb 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2005

Primary Completion Date

Not provided

Completion Date

Aug 2006

First Submitted Date

Sep 12, 2005

First Submission Date that Met QC Criteria

Sep 12, 2005

First Posted Date

Sep 16, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 28, 2007

Last Update Posted Date

Mar 1, 2007Estimated

Name	Class
ZonMw: The Netherlands Organisation for Health Research and Development	OTHER

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Forearm blood flow
Vasoactive effect of caffeine
Sympathetic activity (noradrenaline spillover, spectral analysis)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy volunteers

Exclusion Criteria:

Pregnancy
Asthma
Use of medication
Cardiovascular/pulmonary disease and diabetes

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Paul Smits, MD, PhD	Radboud University Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Radboud University Nijmegen Medical Centre		Nijmegen		6500HB	Netherlands

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
11254897	Background	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.

ID	Term
D009765	Obesity
D024821	Metabolic Syndrome
D000783	Aneurysm

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

ID	Term
D006025	Glycosaminoglycans
D011134	Polysaccharides
D002241	Carbohydrates

Name	Type	Description	Arm Group Labels	Other Names
Intravenous infusion of Intralipid/heparin	Drug
Intravenous infusion of Glycerol/heparin	Drug