Metabolic Syndrome as Breast Cancer Risk FactorNCT01172886
Metabolic Syndrome as Modifiable Risk Factor for Breast Cancer
An observational study of Metabolic Syndrome as Breast Cancer Risk Factor, run by Sbarro Health Research Organization at 1 site in Italy.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 35 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome as Breast Cancer Risk Factor
- How many people
- 777 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2008to Dec 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy women and women operated for breast cancer
Who may be able to join
- healthy women
- women operated for breast cancer
Who cannot join
- Liver or renal disease,
- thyroid pathology
- coronary artery disease
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Dept. of Senology - National Cancer Institute of Naples
Naples, Italy, 80131
immacolata capasso, MD, 00393381829067, icapasso@tiscali.it
immacolata capasso, MD
About this study
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.
Read the 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.
- Keywords
- Metabolic Syndrome obesity visceral adiposity breast cancer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2010 (estimated)
- Study startJan 2008
- Primary completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Syndrome as Breast Cancer Risk FactorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 777 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sbarro Health Research Organization
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01172886
- Sponsor's protocol ID
- icapasso
- Status last verified
- Feb 2010
- First submitted
- 29 Jul 2010
- Last updated
- 30 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Syndrome as Modifiable Risk Factor for Breast Cancer
- ClinicalTrials.gov ID
- NCT01172886
- Acronym / sponsor ID
- icapasso
- Keywords
- Metabolic Syndrome obesity visceral adiposity breast cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 777 participants (estimated)
- Lead sponsor
- Sbarro Health Research OrganizationUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Dec 2009 (actual)
- First posted
- 30 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 35 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy women and women operated for breast cancer
Key inclusion criteria (2 listed)
- healthy women
- women operated for breast cancer
Key exclusion criteria (3 listed)
- Liver or renal disease,
- thyroid pathology
- coronary artery disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2010.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic Syndrome as Breast Cancer Risk Factor, run by Sbarro Health Research Organization at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact emanuela esposito, MD (00393381829067, emanuelaexpo@hotmail.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2010.