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Association Between Maternal Metabolic Disturbances During the First Pregnancy and Breast Density

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ClinicalTrials.gov Identifier: NCT03920098
Recruitment Status : Recruiting
First Posted : April 18, 2019
Last Update Posted : August 9, 2019
Sponsor:
Collaborators:
Pontificia Universidad Catolica de Chile
Servicio de Salud Metropolitano Sur Oriente
Information provided by (Responsible Party):
Dr. Maria Luisa Garmendia, Instituto de Nutrición y Tecnología de los Alimentos

Study Description
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Brief Summary:
Background. Breast cancer (BC) is the leading cause of cancer-related mortality in Chilean women. Mammographic density (BD) refers to the percentage of dense tissue of an entire breast. A high BD is the strongest known risk factor for BC. BD is partially modifiable; the first full term pregnancy (FFTP) reduces BD by average 12%. However, half of the women have no changes in BD after their FFTP and there is no evidence about factors that influence this lack of reduction. Identifying women who do not reduce BD after their FFTP and the potential factors associated with this lack of reduction would help to recognize a subgroup of women with greater vulnerability to BC. In some women, such as obese pregnant women of women with gestational diabetes (GDM), the metabolic adaptations are exaggerated and they show a disturbed metabolic milieu (characterized by hyperinsulinemia, hyperglycemia, higher C-reactive protein levels, and lower level of sex hormone-binding globulin), which may have biological effects on breast composition during this period of breast differentiation. Hypothesis. The hypothesis of the study proposes that the women with an altered metabolic milieu during their first full-term pregnancy will have higher breast density measured through DXA three months after cessation of lactation, when fully breast involution after pregnancy is achieved, compared to women without metabolic disturbances during their first full-term pregnancy. General Objective. The main goal is to evaluate in a cohort of primipara women the association between an altered metabolic milieu during pregnancy and breast density measured by DXA three months after breastfeeding cessation. Methods. One thousand pregnant women will be recruited at the beginning of their first pregnancy and evaluated at <15, 24-38 and 35-37 weeks during pregnancy and three months after breastfeeding cessation, as part of a longitudinal study. The main outcome will be breast composition measures three months after breastfeeding cessation. The main predictor will be metabolic status during pregnancy. Three months after breastfeeding cessation will record delivery data and a breast DXA exam will be carried out. Multiple linear regression models and generalized estimated equations will be used to explain this relationship. Expected results. The ultimate goal is to provide evidence on how to prevent breast cancer risk by reducing breast density.

Condition or disease Intervention/treatment
Breast Density Other: Altered metabolic milieu during first full term pregnancy

Study Design
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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Association Between Maternal Metabolic Disturbances During the First Pregnancy and Breast Density
Actual Study Start Date : July 1, 2019
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : April 2023
Groups and Cohorts
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Group/Cohort Intervention/treatment
Primipara pregnant women
Primipara pregnant women
 Other: Altered metabolic milieu during first full term pregnancy
The altered metabolic milieu is defined as a fasting glucose level >100 mg/dL at the first trimester of pregnancy by national guidelines. Altered metabolic milieu during the second trimester (24-28 weeks of pregnancy) is defined as a fasting glucose levels > 92 mg/dL and/or plasma glucose levels > 153 mg/dL two hours afterload in the oral glucose tolerance test according to ADA guidelines or a fasting glucose >100 mg/dL and/or > 140 mg/dL two hours afterload in the oral glucose tolerance test according to national guidelines.
Other Name: Altered metabolic milieu


Outcome Measures
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Primary Outcome Measures :
  1. Breast absolute fibro-glandular volume (AFGV) measured by DXA technique [ Time Frame: Three months after breastfeeding cessation ]
    cm3 and tertiles of their distribution estimated by DXA technique

  2. Breast percentage of fibro-glandular volume (%FVG) measured by DXA technique [ Time Frame: Three months after breastfeeding cessation ]
    percentage and tertiles of their distribution estimated by DXA technique


Biospecimen Retention:   Samples Without DNA
Additional fasting venous samples will be collected during routine public health care blood extractions. Plasma and red blood cells will be separated by centrifugation within the next 3 hours in the County´s laboratory. Red blood cells will be eliminated and plasma specimens will be aliquot and keep to -80ºC until the determination of metabolic markers, growth factors and hormones.

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Primipara pregnant women
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
The population is women seeking prenatal care in any of 12 public health care centers (PHCC) of Puente Alto and La Florida counties. Puente Alto and La Florida are low- and middle-income levels counties located in the city of Santiago, Chile.
Criteria

Inclusion Criteria:

  • Primipara (no previous pregnancies)
  • 18 to 25 years of age
  • Gestation <15 weeks at first prenatal visit
  • No intention to move outside the city of Santiago in the next to years

Exclusion Criteria:

  • Multipara
  • Pre-existing cancer (except non-melanoma skin cancer)
  • Family history of breast cancer (one first-degree female relative diagnosed with breast cancer)
  • High-risk pregnancy according to national guidelines
  • During the follow-up, pregnant women under any treatment that may affect the levels of metabolic markers will be excluded from the analysis
  • Pregnant women with pre-eclampsia or with preterm birth (less than 37 weeks of gestational age) will be also excluded
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03920098


Contacts
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Contact: María L Garmendia, PhD 56229781402 mgarmendia@inta.uchile.cl

Locations
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Chile
Corporación de Salud Municipal de Puente Alto Recruiting
Santiago de Chile, Puente Alto, Chile, 8210269
Contact: Marcela Flores, MSc    +56948545449    marcela.flores@cmpuentealto.cl   
Sponsors and Collaborators
Instituto de Nutrición y Tecnología de los Alimentos
Pontificia Universidad Catolica de Chile
Servicio de Salud Metropolitano Sur Oriente
Investigators
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Principal Investigator: María L Garmendia, PhD Instituto de Nutrición y Tecnología de Alimentos
More Information
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Publications:

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Responsible Party: Dr. Maria Luisa Garmendia, Associate Professor, Instituto de Nutrición y Tecnología de los Alimentos
ClinicalTrials.gov Identifier: NCT03920098    
Other Study ID Numbers: 1190532
First Posted: April 18, 2019    Key Record Dates
Last Update Posted: August 9, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Maria Luisa Garmendia, Instituto de Nutrición y Tecnología de los Alimentos:
Breast densities
Breast neoplasms
Glucose metabolism disorders
Diabetes, gestational
Glycated Hemoglobin A
Insulin-Like Growth Factor I
 Pregnancy
Gestation
Primary Health Care
Dual-energy X-ray Absorptiometry
Latin America
Chile