Targeting systemic inflammation to improve endothelial function in obesity

ISRCTN	ISRCTN14884558
DOI	https://doi.org/10.1186/ISRCTN14884558
EudraCT/CTIS number	2009-016855-23
Secondary identifying numbers	9379

Submission date: 10/06/2011
Registration date: 10/06/2011
Last edited: 19/05/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Not provided at time of registration

Contact information

Dr Stephen B Wheatcroft
Scientific

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

Phone	+44 113 343 7760
Email	s.b.wheatcroft@leeds.ac.uk

Study information

Study design	Randomised; Interventional; Design type: Not specified, Treatment
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	Targeting systemic inflammation to improve endothelial function in obesity
Study hypothesis	The aim of this study is to investigate the effect of reducing inflammation with pentoxifylline on vascular endothelial function in individuals with obesity
Ethics approval(s)	02/02/2010, ref: 10/H1005/5
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
Pharmaceutical study type(s)
Phase	Phase IV
Drug / device / biological / vaccine name(s)	Pentoxifylline
Primary outcome measure	Flow mediated dilatation of brachial artery (%); Timepoint(s): at end of treatment period
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/12/2010
Overall study end date	01/02/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	65 Years
Sex	Both
Target number of participants	Planned Sample Size: 50; UK Sample Size: 50
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 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

England
United Kingdom

Study participating centre

The Light Laboratories

Leeds
LS2 9DA
United Kingdom

Sponsor information

University of Leeds (UK)
University/education

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

Website	http://www.leeds.ac.uk/
"ROR"	https://ror.org/024mrxd33

Funders

Funder type

Charity

Heart Research UK (UK)
Private sector organisation / Other non-profit organizations

Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Basic results		26/07/2020	19/05/2022	No	No
HRA research summary			28/06/2023	No	No

Editorial Notes

19/05/2022: EU Clinical Trials Register results added.
07/03/2017: No publications found in PubMed, verifying study status with principal investigator