OBESITY AND ASPIRIN RESPONSIVENESS

Conditions: OBESITY
MedDRA version: 15.0Level: PTClassification code 10029883Term: ObesitySystem Organ Class: 10027433 - Metabolism and nutrition disorders
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2012-002755-42-IT

Lead Sponsor: POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 40

Inclusion Criteria

willingness to participate expressed through an informed consent
- obesity defined as BMI = 30 kg/m2
- age: 18-60 yrs
- blood pressure within the normal limits, with or without pharmacological control
- blood cholesterol within the normal limits with or without pharmacological control. Permitted medications will be: oral contraceptives, statins, anti-hypertensive drugs, paracetamol as antipyretic/analgesic drug.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Previous major thrombotic events (both arterial and venous)
- Smoking habits (>3 cigarettes/day)
- overt diabetes
- un-controlled hypertension
- severe liver or kidney impairment
- need for nonsteroidal anti-inflammatory drugs (NSAIDs), antiplatelet or anticoagulant treatments
- Pregnancy or lactation

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate whether obesity is associated with a reduced response to low-dose aspirin and to characterize the determinants of this abnormal response.;Secondary Objective: NA;Primary end point(s): To investigate the kinetics of aspirin responsiveness in otherwise healthy obese subjects, measured as serum TXB2.;Timepoint(s) of evaluation of this end point: 42 DAYS

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): To evaluate the effect of successful weight loss on aspirin responsiveness;Timepoint(s) of evaluation of this end point: 42 DAYS