Preventing Breast cancer through Assumption of Metformin, Diet and Physical Activity - Bremet Diet

Conditions: women affected by metabolic syndrome defined by at least three out of five metabolic factors: 1-glucose >110 mg/100 mL 2-triglycerides >150mg/100mL 3-HDL cholesterol <50 mg/100mL 4-waist circumference >88 cm) 5-hypertension SBP>130 mm Hg or DBP >85 mm H
MedDRA version: 9.1Level: SOCClassification code 10038604
MedDRA version: 9.1Level: SOCClassification code 10029104
MedDRA version: 9.1Level: PTClassification code 10007649
MedDRA version: 9.1Level: SOCClassification code 10022891

Registration Number: EUCTR2008-006527-30-IT

Lead Sponsor: ISTITUTO NAZIONALE PER LA CURA TUMORI

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Female

Target Recruitment: Not specified

Inclusion Criteria

A)Women aged 40 year or more B)women affected by metabolic syndrome defined by at least three out of five metabolic factors: 1-glucose >110 mg/100 mL 2-triglycerides >150mg/100mL 3-HDL cholesterol <50 mg/100mL 4-waist circumference >88 cm) 5-hypertension SBP>130 mm Hg or DBP >85 mm Hg C)high mammographic breast density. D)high risk score based on classical non modifiable risk factors (family history, nulliparity or late pregnancy, early menarche, late menopause, etc)
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) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

A) age<40 years

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: whether the assumption of Metformin,a combined lifestyle intervention aimed at promoting moderate physical activity, reducing or controlling body weight, and improving diet, will result in a significantly reduced breast cancer incidence in high risk women.;Secondary Objective: the effect of the Metformin administration and lifestyle changes on total cancer incidence and all-cause mortality;Primary end point(s): incidence of breast cancer in patients with high risk profile.

Secondary Outcome Measures