Children Follow-up of PCOS Women.Cardiovascular Health in Offspring of PCOS Mothers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- UMC Utrecht
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Echocardiography (age 2.5-4 years)
研究概览
简要总结
Polycystic ovary syndrome (PCOS) is a complex and frequent disorder with a heterogeneous clinical presentation varying throughout life, from birth up to post-menopause. Although mostly known for its reproductive consequences, PCOS is associated with metabolic abnormalities related to insulin resistance and obesity. Children born from PCOS mothers are considered to be at risk for early insulin resistance, leading to development of PCOS and metabolic abnormalities in childhood and adolescence. Obesity and insulin resistance are considered as states of low- and pro-inflammation associated with endothelial dysfunction. In addition, it has been shown that endothelial dysfunction develops from the first decade of life in response to genetic and environmental risk factors. Therefore, offspring of women with PCOS may be at increased risk for vascular disease later in life. Moreover, some evidence suggests that early life respiratory disease also contributes to later life cardiovascular consequences. The number of studies on offspring of PCOS mothers is low and a systematic follow up of children born form PCOS mothers has not been performed yet. the investigators propose a systematic evaluation of cardiometabolic and pulmonary health characteristics of children (aged 2,5-8 years) born from mothers diagnosed with PCOS. A saliva sample will be performed to determine the biochemical androgenic status of the children. Mothers of these children have undergone standardized phenotyping prior to conception; the investigators will therefore be able to correlate the metabolic status of the mother around the time of conception and the cardiometabolic and pulmonary health of their offspring.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 30 Months 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Children
- •Children participating in WHISTLER study or children of PCOS mothers
- •Aged 2.5-4 years or 6-8 years
排除标准
- •Language barrier
- •Children with a history of a heart defect
- •Children with a respiratory infection or respiratory infection two weeks previous to the visit are asked to reschedule the appointment.
- •Residency outside the Netherlands
- •Diabetes Mellitus type I
- •Unresolved medical conditions
结局指标
主要结局
Echocardiography (age 2.5-4 years)
时间窗: 12 months
Echocardiography will be performed in a supine position. Three ECG electrodes will be attached on the skin. The child can watch a movie during the measurements. Using M-mode and Tissue Doppler Echocardiography several measurements of the systolic and diastolic function of the right and left ventricle will be performed.
Pulse wave velocity (age 2.5-4 years)
时间窗: 12 months
The pulse wave velocity will be measured twice using the Arteriograph at the right arm. This measurement will start by performing a blood pressure measurement at the first phase. In the second phase the pulse wave recording for pulse waveform analysis is performed. First the device will inflate back to the measured diastolic value and register the pulse waves and second, the device inflates further to the suprasystolic value (to the measured systolic value +35 mmHg), occluding the brachial artery completely in this way and registers the pulse waves.
Carotid intima media thickness (age 6-8 years)
时间窗: 12 months
The carotid IMT will be determined by using ultrasound based on the gold standard Wall Track System (Art.lab System, Esaote and the Cardiovascular Research Institute Maastricht).
Fat mass determination (6-8 years)
时间窗: 12 months
The intra-abdominal fat will be assessed by ultrasound by determination of the distance between the posterior side of the linea alba and the anterior vertebrae. The subcutaneous fat will be determined by measuring the distance between the anterior side of the linea alba and the skin. Both fat compartments will be assessed longitudinally.
Anthropometry (both age categories)
时间窗: 12 months
Body height and weight will be measured to the nearest 0.1 cm and 0.1 kg respectively without wearing shoes. Distance between the jugular fossa and symphysis will be measured (needed for calculation of pulse wave velocity). Waist circumference will be measured twice at the bare skin using a non-elastic measuring tape, between the superior iliac anterior spine and the lowest rib in a horizontal line, at the end of a normal expiration. Hip circumference will be measured twice over light clothing at the most posterior point of the buttocks. Thoracic circumference will be measured at the end of the expiration and signs of respiratory disease will be noted.
Blood sample (6-8 years)
时间窗: 12 months
The venous puncture will be performed for the collection of the blood sample by using a butterfly needle, since this needle is smaller than the needles commonly used for venous puncture (vacutainer system) and will therefore reduce the pain of the venous puncture for the children. The venipuncture will be performed in a vein in the cubital fossa. Two different tubes of blood will be drawn, one sodium-heparin and one lithium-heparin tube, with in total a maximum of 19 cc blood. Prior to the venous puncture, a local anaesthetic, xylocaine spray, will be used at the location of the puncture.
次要结局
- Saliva sample (both age categories)(12 months)
- Inflammatory markers in exhailed air(12 months)
- Airway resistance (both age categories)(12 months)
- Flow-volume measurements(12 months)
研究者
Bart CJM Fauser
Professor of Reproductive Medicine
UMC Utrecht