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Completed

NCT Number: NCT02282592

Metabolic Syndrome and Female Breast Cancer

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Neoplasms Neoplasms by Site Nutritional and Metabolic Diseases Skin Diseases Skin and Connective Tissue Diseases

Sex eligibility

Female

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Observation about the presence of metabolic syndrome

Other

Primary outcomes

  1. Odds Ratio for Breast Cancer according to the presence of Metabolic Syndrome and its components

    Time frame: 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.

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Sponsors and collaborators

Lead sponsor

Catholic University of Pelotas

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Nov 4, 2014
Registry last updated
Nov 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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