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.
Conditions
Interventions
Trade Name: Trental 400
Product Name: Trental 400 [pentoxifylline]
Pharmaceutical Form: Capsule*
INN or Proposed INN: pentoxifylline
Concentration unit: mg milligram(s)
Concentration type: equal
Conce
Sponsors
University of Leeds
Eligibility
Sex/Gender
All
Inclusion criteria
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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Does reducing inflammation in obese volunteers, using pentoxifylline, lead to an improvement in the health of blood vessels? We will measure the health of blood vessels by taking blood samples and carrying out an ultrasound scan of the blood vessel in the arm before and after treatment. This will address whether inflammation causes 'unhealthy' blood vessels in people with obesity.;Secondary Objective: Does reducing inflammation in obese volunteers, using the drug pentoxifylline, alter markers of blood vessel damage and repair in the blood? Everyone has small numbers of endothelial microparticles (tiny fragments of cells lining blood vessels) and endothelial progenitor cells (cells which come from the bone marrow and help to repair blood vessels)in their blood stream. Measuring the relative numbers of endothelial microparticles and endothelial progenitor cells in the blood stream gives an indication of how healthy the blood vessels are. ;Primary end point(s): Flow-mediated dilatation (FMD) of the brachial artery | — |
Countries
United Kingdom
Outcome results
None listed