Metabolic Syndrome as Modifiable Risk Factor for Breast Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by Sbarro Health Research Organization.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Sbarro Health Research Organization
ClinicalTrials.gov Identifier:
NCT01172886
First received: July 29, 2010
Last updated: NA
Last verified: February 2010
History: No changes posted
  Purpose

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.


Condition
Metabolic Syndrome as Breast Cancer Risk Factor

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Metabolic Syndrome as Modifiable Risk Factor for Breast Cancer

Resource links provided by NLM:


Further study details as provided by Sbarro Health Research Organization:

Biospecimen Retention:   Samples Without DNA

Blood samples


Estimated Enrollment: 777
Study Start Date: January 2008
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   35 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Healthy women and women operated for breast cancer

Criteria

Inclusion Criteria:

  • healthy women
  • women operated for breast cancer

Exclusion Criteria:

  • Liver or renal disease,
  • thyroid pathology
  • coronary artery disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01172886

Contacts
Contact: emanuela esposito, MD 00393381829067 emanuelaexpo@hotmail.it

Locations
Italy
Dept. of Senology - National Cancer Institute of Naples Recruiting
Naples, Italy, 80131
Contact: immacolata capasso, MD    00393381829067    icapasso@tiscali.it   
Principal Investigator: immacolata capasso, MD         
Sponsors and Collaborators
Sbarro Health Research Organization
  More Information

No publications provided

Responsible Party: Sbarro Health Research Organization, Immacolata Capasso- Dept. of Senology- National Cancer Institute of Naples
ClinicalTrials.gov Identifier: NCT01172886     History of Changes
Other Study ID Numbers: icapasso
Study First Received: July 29, 2010
Last Updated: July 29, 2010
Health Authority: Italy: National Institute of Health

Keywords provided by Sbarro Health Research Organization:
Metabolic Syndrome obesity visceral adiposity breast cancer

Additional relevant MeSH terms:
Metabolic Syndrome X
Syndrome
Breast Neoplasms
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Disease
Pathologic Processes
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 30, 2014