Metabolic Syndrome as Modifiable Risk Factor for Breast Cancer

Healthy women and women with breast cancer have been enrolled in our nested case-control study between 2008 and 2009 in order to evaluate the association between metabolic syndrome and breast cancer, analyzing anthropometric parameters blood pressure, assessing serum HDL-C, triglyceride, fasting plasma glucose, insulin, testosterone and uric acid levels and administering a questionnaire about physical activity, food intake, tobacco use, alcohol abuse, personal and familial history of disease. Our data support the hypothesis that metabolic syndrome may be an indicator of breast cancer risk in postmenopausal women. The change of the hormonal arrangement in postmenopausal, along with an increase in visceral adiposity, probably favour the hormone dependent cell proliferation, which drives tumorigenesis. Adjustments in lifestyle with physical activity intensification and healthy diet may represent modifiable factors on which sporadic breast cancer primary prevention may work on.

Study Overview

• Status: Unknown
• Conditions: Metabolic Syndrome as Breast Cancer Risk Factor

Detailed Description

A total of 777 patients have been enrolled in our nested case-control study. 293 of them operated for breast cancer (cases) and 484 healthy women (controls) have been recruited between 2008 and 2009 to take part to our study for evaluating the association between MS and breast cancer. Liver or renal disease, thyroid pathology and coronary artery disease were considered exclusion criteria. After obtaining informed consent, signing the authorization to be enrolled in the study, for each woman anthropometric features were measured, including weight in kilograms, height in meters, waist and hip circumference, arterial blood pressure was taken and venous blood was collected [15]. BMI (kg/m²) was calculated from weight and height values according to World Health Organization classification (< 25 kg/m²= underweight/normal, ≥ 25 kg/m²= overweight/obese), waist and hip ratio (WHR) was obtained from waist and hip circumference, measuring the smallest circumference of both to discriminate between android and gynoid fat distribution [22]. From blood samples fasting plasma glucose, HDL-C, triglyceride, uric acid, insulin and testosterone levels were assessed. Fasting plasma glucose, HDL-C and triglyceride were measured according to NCEP ATP III criteria. The normal range for uricemia was 2.6-6.0 mg/dl. Insulin levels were defined in normal range when between 5 and 25 mcU/ml, whereas ≥ 25 mcU/ml were considered hyperinsulinemia. Testosterone levels were considered in the normal range when 0.20-1.20 ng/ml. Levels > 1.20 ng/ml were considered indicative of hyperandrogenic status. Women were asked to answer a questionnaire about chronic diseases, tobacco use, alcohol abuse, food intake, physical activity grade, parity, age of menarche, menopausal status, oral contraceptive use, hormonal therapy use, personal and familial history of cancer. According to the NCEP ATP III [10], women presenting three disorders were diagnosed with low grade MS [5], whereas women presenting more than three disorders (four or five) were diagnosed with high grade MS. Chi-squared test and logistic regression analyses (OR and 95% CI) were used to confirm the association between MS and breast cancer and to calculate the risk. Statistical significance was considered at P < 0.05.

• Study Type: Observational
• Enrollment (Anticipated): 777

Contacts and Locations

• Study Contact: Name: emanuela esposito, MD; Phone Number: 00393381829067; Email: emanuelaexpo@hotmail.it

Study Locations

• Italy
  • Naples, Italy, 80131
    • Recruiting
    • Dept. of Senology - National Cancer Institute of Naples
    • Contact: immacolata capasso, MD; Phone Number: 00393381829067; Email: icapasso@tiscali.it
    • Principal Investigator: immacolata capasso, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Healthy women and women operated for breast cancer

Description

Inclusion Criteria:

• healthy women
• women operated for breast cancer

Exclusion Criteria:

• Liver or renal disease,
• thyroid pathology
• coronary artery disease

Study Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: Sbarro Health Research Organization

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: July 29, 2010
• First Submitted That Met QC Criteria: July 29, 2010
• First Posted (Estimate): July 30, 2010

Study Record Updates

• Last Update Posted (Estimate): July 30, 2010
• Last Update Submitted That Met QC Criteria: July 29, 2010
• Last Verified: February 1, 2010

More Information

Terms related to this study

• Keywords: Metabolic Syndrome obesity visceral adiposity breast cancer
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Skin Diseases; Neoplasms; Neoplasms by Site; Disease; Breast Diseases; Insulin Resistance; Hyperinsulinism; Syndrome; Breast Neoplasms; Metabolic Syndrome
• Other Study ID Numbers: icapasso