OBESITY MedDRA version: 15.0 Level: PT Classification code 10029883 Term: Obesity System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Trade Name: ASPIRINA*BB 24CPR 100MG
Pharmaceutical Form: Gastro-resistant tablet
INN or Proposed INN: ASPIRIN
CAS Number: 50-78-2
Concentration unit: mg milligram(s)
Concentration type: up to
Concentr
Sponsors
POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Italy
Contacts
Public ContactMedicina interna CIC
POLICLINICO GEMELLI
Outcome results
None listed