The study aims to investigate the effects of breastfeeding on lipid profile and cardiovascular risk markers in women with familial hypercholesterolemia (FH) compared to women without FH. Women with FH will be recruited in Norway, the Netherlands, and the Czech Republic. Women without FH will be recruited in Norway. Women with and without FH who are pregnant or planning pregnancy will be recruited, and will be invited to repeated study visits from the end of pregnancy and through the first year after delivery. Blood samples and data on anthropometry, health, pregnancy, lifestyle and diet will be collected. Statin transfer into breast milk will also be measured in breast milk samples collected when the women end breastfeeding the child and start statin treatment.
Patients with familial hypercholesterolemia (FH) have elevated plasma levels of LDL-cholesterol from first years of life. Cholesterol burden through life defines risk of cardiovascular disease. In women with FH, cholesterol levels increase during pregnancy both due to physiological changes as well as discontinuation of cholesterol lowering medication during planning of pregnancy, during the pregnancy and during breastfeeding. Few studies on the effects of breastfeeding on lipid profile in women with FH exists. There is also limited data on whether and to what extent the cholesterol lowering statins transfer to breast milk. The study aims to investigate the effects of breastfeeding on lipid profile and cardiovascular risk markers in women with familial hypercholesterolemia (FH) compared to women without FH. Women with and without FH who are pregnant or planning pregnancy will be recruited, and will be invited to repeated study visits from the end of pregnancy and through the first year after delivery. Blood samples and data on anthropometry, health, pregnancy, lifestyle and diet will be collected. Statin transfer into breast milk will also be measured in breast milk samples collected when the FH women end breastfeeding the child and start statin treatment.
Study Type
OBSERVATIONAL
Enrollment
50
Centre of Cardiovascular Surgery and Transplantation
Brno, Czechia
Third Department of Internal Medicine, General University Hospital, First Faculty of Medicine, Charles University
Prague, Czechia
Department of Internal Medicine, Erasmus MC Cardiovascular Institute
Rotterdam, Netherlands
Oslo University Hospital
Oslo, Norway
Change in serum lipid profile (total cholesterol, LDL-C, HDL-C, triglycerides, lipoprotein(a)) from 2-4 weeks postpartum up to 12 months postpartum (absolute and relative change).
Investigate the change in lipid profile (total cholesterol, LDL-cholesterol, HDL-cholesterol and triglycerides) in women with and without familial hypercholesterolemia, by blood sampling at repeated time points during breastfeeding period.
Time frame: Up to 12 months after delivery or end of breastfeeding period
Association between breastfeeding (yes/no, exclusive/partial, frequency, and duration) and inflammatory markers (e.g. C-reactive protein (CRP).
Investigate the association between breastfeeding (yes/no, exclusive/partial, frequency, and duration) and inflammatory markers (e.g. C-reactive protein) in women with and without familial hypercholesterolemia. Measurements will be performed in both plasma/serum and in peripheral blood mononuclear cells (PBMC) (gene expression levels).
Time frame: Up to 12 months after delivery or end of breastfeeding period
Association between breastfeeding (yes/no, exclusive/partial, frequency, and duration) and metabolic markers (e.g. glucose).
Investigate the association between breastfeeding (yes/no, exclusive/partial, frequency, and duration) and metabolic markers (e.g. glucose) in women with and without familial hypercholesterolemia. Measurements will be performed in both plasma/serum.
Time frame: Up to 12 months after delivery or end of breastfeeding period
Association between breastfeeding (yes/no, exclusive/partial, frequency, and duration) and maternal weight.
Investigate the association between breastfeeding (yes/no, exclusive/partial, frequency, and duration) and maternal weight in women with and without familial hypercholesterolemia.
Time frame: Up to 12 months after delivery or end of breastfeeding period
Investigate the breast milk composition (lipids and metabolites) throughout the breastfeeding period.
Perform lipid profiling (lipidomics) and metabolite profiling (metabolomics) and analyze contaminants in breast milk samples of women with FH and without FH. Breast milk samples will be collected at repeated time points through breast feeding period
Time frame: Up to 12 months after delivery or end of breastfeeding period
Investigate the concentration of statins in the breast milk and dried blood spot of the offspring of women with FH after start of lipid-lowering medication.
Investigate the concentration of statin (HMG-CoA reductase inhibitors) (e.g. atorvastatin, rosuvastatin) in breast milk and dried blood spot of the offspring, if possible when the women re-start ordinary treatment. Fewer samples are expected from this time point, as it may be challenging to synchronize the initiation of lipid-lowering treatment with the end of breastfeeding.
Time frame: Repeated milk sampling up to one week after start of ordinary statin treatment.
Investigate the concentration of total cholesterol and metabolic markers in dried blood spots collected at 12 months postpartum in offspring of women with FH
Investigate the concentration of total cholesterol and other metabolic markers in infants of women with FH, at 12 months of age, using dried blood spots (DBS).
Time frame: Measurement at infant age 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.