Metabolic Syndrome and Female Breast Cancer

Breast Cancer Clinical Trial

Official title:

Metabolic Syndrome and Female Breast Cancer: a Case-control Study in Southern Brazil

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02282592
• Other study ID #: 481.165
• Status: Completed
• Phase: N/A
• First received: October 17, 2014
• Last updated: October 31, 2014
• Start date: November 2013
• Est. completion date: October 2014

Study information

• Verified date: October 2014
• Source: Catholic University of Pelotas
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Observational

Clinical Trial Summary

The role among metabolic syndrome and breast cancer risk is not well understood and must be further explored. The objective of this study is to evaluate the association between metabolic syndrome and breast cancer in Southern Brazil. In this case-control study, breast cancer patients and controls without malignant disease, matched for age (±5 years) and menopausal status, were interviewed and asked to make a glucose, HDL-cholesterol and triglycerides test. Waist circumference and blood pressure were measured using standardized procedures. Metabolic Syndrome was considered by NCEP ATP III (2001) and IDF (2006) definitions. Cases and controls were compared in relation to the presence of diagnosed MetS (yes/no), number of metabolic abnormalities identified (1 to 5) for each definition, and according to each metabolic abnormality cutoff point.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 164
• Est. completion date: October 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• For cases: having newly diagnosed breast cancer without adjuvant or neoadjuvant treatment;

• For controls: having no evidence of cancer; be matched for age and menopausal status with controls

Exclusion Criteria:

• Women with a recidivated tumor, HIV infection, renal, heart or liver disease, hypothyroidism or hyperthyroidism, mobility or neurological limitations, chronicle use of corticosteroids, pacemakers or identified with severe edema were excluded.

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Metabolic Syndrome X

Intervention

Other:
• Observation about the presence of metabolic syndrome

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Catholic University of Pelotas

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Odds Ratio for Breast Cancer according to the presence of Metabolic Syndrome and its components		Participants will be evaluated only once before the first appointment with the oncologist (cases with a biopsy) and gynecologist (controls). The blood test results for Metabolic Syndrome parameters were collected in an expected average of 30 days.	Yes