Effect of Breastfeeding on Lipid Profile and Cardiovascular Risk Markers in Women With Familial Hypercholesterolemia (FH-FEMINA)
概览
- 阶段
- 不适用
- 干预措施
- Women with familial hypercholesterolemia
- 疾病 / 适应症
- Familial Hypercholesterolemia
- 发起方
- Oslo University Hospital
- 入组人数
- 50
- 试验地点
- 4
- 主要终点
- 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).
- 状态
- 进行中（未招募）
- 最后更新
- 2个月前
概览
简要总结
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.
详细描述
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.
研究者
Kirsten Bjørklund Holven
Professor
Oslo University Hospital
入排标准
入选标准
- •for women with FH:
- •age 18 years or older,
- •confirmed diagnosis of FH through genetic testing or clinical assessment based on the Dutch Lipid Clinic Network,
- •singleton pregnancy in the third trimester,
- •a sufficient command of Norwegian, Dutch, Czech or English language.
排除标准
- •for women with FH:
- •Not filling the inclusion criteria.
- •Inclusion Criteria for women without FH:
- •age 18 years or older,
- •singleton pregnancy in the third trimester,
- •a sufficient command of Norwegian or English language.
- •Exclusion Criteria for women without FH:
- •known pre-pregnancy hypercholesterolemia,
- •a history of ASCVD.
研究组 & 干预措施
Women with familial hypercholesterolemia
Women with familial hypercholesterolemia
Women without hypercholesterolemia
Women without hypercholesterolemia
结局指标
主要结局
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).
时间窗: Up to 12 months after delivery or end of breastfeeding period
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.
次要结局
- Association between breastfeeding (yes/no, exclusive/partial, frequency, and duration) and inflammatory markers (e.g. C-reactive protein (CRP).(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).(Up to 12 months after delivery or end of breastfeeding period)
- Association between breastfeeding (yes/no, exclusive/partial, frequency, and duration) and maternal weight.(Up to 12 months after delivery or end of breastfeeding period)
- Investigate the breast milk composition (lipids and metabolites) throughout the breastfeeding period.(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.(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(Measurement at infant age 12 months)