Targeting systemic inflammation to improve endothelial function in obesity - Inflammation, obesity and endothelial functio

Phase 1

• Conditions: Healthy volunteer trial in obese subjects (body mass index 30 or greater) in which the IMP will be used to reduce inflammation by inhibiting tumour necrosis factor(TNF)-a in order to assess the effects on vascular function.

• Registration Number: EUCTR2009-016855-23-GB
• Lead Sponsor: niversity of Leeds

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07-19
• Last Update Posted: 19 December 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

age 18-65
obesity (Body Mass Index 30 or greater)
not taking other medication (apart from oral contraceptives)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

diabetes
hypertension
hyperlipidaemia
cardiovascular disease or history of cardiac arrythmias
chronic inflammatory disorders (e.g. rheumatoid arthritis, connective tissue disorders, gout, inflammatory bowel disease, chronic infections)
acute inflammatory illnesses (e.g. upper respiratory tract infections)
allergy to pentoxifylline or other methyl xanthine drugs or concomitant use of sildenafil, tadalafil, vardenafil or other phosphodiesterase 5 inhibitors
history of cerebral haemorrhage or retinal haemorrhage
pregnancy or breastfeeding
Impaired renal function
Hypotension (systolic blood pressure less than 90mmHg)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified