Condition category
Nutritional, Metabolic, Endocrine
Date applied
10/06/2011
Date assigned
10/06/2011
Last edited
15/05/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Stephen B Wheatcroft

ORCID ID

Contact details

The Light Laboratories
University of Leeds
Clarendon Way
Leeds
LS2 9DA
United Kingdom
s.b.wheatcroft@leeds.ac.uk

Additional identifiers

EudraCT number

2009-016855-23

ClinicalTrials.gov number

Protocol/serial number

9379

Study information

Scientific title

Acronym

Study hypothesis

To investigate the effect of reducing inflammation with pentoxifylline on vascular endothelial function in individuals with obesity

Ethics approval

10/H1005/5; First MREC approval date 02/02/2010

Study design

Randomised; Interventional; Design type: Not specified, Treatment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Topic: Cardiovascular; Subtopic: Cardiovascular (all Subtopics); Disease: Cardiovascular

Intervention

A total of 50 participants with obesity will be randomised to receive pentoxifylline 400mg tablets or an inactive control preparation three times daily for eight weeks.
Follow Up Length: 2 month(s); Study Entry : Single Randomisation only

Intervention type

Drug

Phase

Phase IV

Drug names

Pentoxifylline

Primary outcome measures

Flow mediated dilatation of brachial artery (%); Timepoint(s): at end of treatment period

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/12/2010

Overall trial end date

01/02/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age 18-65
2. Obesity (Body Mass Index 30 or greater)
3. Not taking other medication (apart from oral contraceptives)
Target Gender: Male & Female; Upper Age Limit 65 years ; Lower Age Limit 18 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 50; UK Sample Size: 50

Participant exclusion criteria

1. Diabetes
2. Hypertension
3. Hyperlipidaemia
4. Cardiovascular disease or history of cardiac arrythmias
5. Chronic inflammatory disorders (e.g. rheumatoid arthritis, connective tissue disorders, gout, inflammatory bowel
disease, chronic infections)
6. Acute inflammatory illnesses (e.g. upper respiratory tract infections)
7. Allergy to pentoxifylline or other methyl xanthine drugs or concomitant use of sildenafil, tadalafil, vardenafil or other phosphodiesterase inhibitors
8. History of cerebral haemorrhage or retinal haemorrhage
9. Pregnancy or breastfeeding
10. Impaired renal function

Recruitment start date

01/12/2010

Recruitment end date

01/02/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

The Light Laboratories
Leeds
LS2 9DA
United Kingdom

Sponsor information

Organisation

University of Leeds (UK)

Sponsor details

The Light Laboratories
University of Leeds
Clarendon Way
Leeds
LS2 9DA
United Kingdom

Sponsor type

University/education

Website

http://www.leeds.ac.uk/

Funders

Funder type

Charity

Funder name

Heart Research UK (UK)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes