GraviD-child Follow-up of the Children´s Health, Growth and Development Within the GraviD-study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 172
- 试验地点
- 1
- 主要终点
- Blood glucose
研究概览
简要总结
GraviD is a multi-ethnic population-based pregnancy cohort. Pregnant women were invited to participate in the GraviD study when registering for antenatal care in parts of the region of Västra Götaland in Sweden in 2013-2014. All women registering for antenatal care were eligible for inclusion, as long as the pregnancy had not exceeded 16 gestational weeks. In total, 2125 pregnant women were recruited in gestational week 12 during two time-periods; fall 2013 and spring 2014. Blood sampling was performed in gestational week <17 and again at gestational week >31 by midwifes. After delivery, the maternity records were obtained, to collect information on child's gender, birth weight and length and other possible birth outcomes.
详细描述
In the GraviD-child study, all healthy singleton children born within the GraviD study will be invited to participate in a single clinical follow up. The follow-up will be conducted when all children are between 7-8 years of age. The study centre is located at the Queen Silvia Children´s hospital in Gothenburg, Sweden. The follow up consist of several parts:
- Measurement of body weight and height, and waist circumference.
- A questionnaire regarding health, physical activity, sleeping habits and diet.
- Endothelial function, a measure of how well the blood vessels dilute.
- Ultra sound of the thickness of the vessels on the neck, wrist and foot
- Pulse wave velocity, to measure the elasticity of the vessels on the neck and groin.
- Body composition using bioelectrical impedance.
- Blood pressure
- A venous blood sample of maximum 18 ml will be drawn to analyze markers of cardiovascular health. Blood lipids (total cholesterol, triglycerides, HDL cholesterol, LDL cholesterol), lipoprotein A, apolipoproteins (Apo A1 and Apo B), liver enzymes, glucose, insulin, HbA1c, c-reactive protein, leptin, adiponectin, nutritional biomarkers (such as 25-hydroxyvitamin D) will be analyzed.
The study hypothesis is that a low maternal vitamin D status increase the risk of an unfavorable child cardiometabolic risk profile, vascular health and body composition.
Recruitment start in January 2022 and will run for about a year.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 7 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Born within the GraviD study
- •Singleton
排除标准
- •Chromosomal abnormality
- •Hyper-/Hypothyroidism
结局指标
主要结局
Blood glucose
时间窗: At 7-9 years of age
Glucose in mmol/L will be analyzed from a venous blood sample
Ultrasound
时间窗: At 7-9 years of age
Ultra-high frequency ultrasound of radialis (in mm) will be measured
Body composition
时间窗: At 7-9 years of age
Fat mass, derived from bioelectrical impedance, will be studied as percentage (%) of the total body weight.
Blood pressure
时间窗: At 7-9 years of age
Blood pressure in mm Hg will be assessed.
Pulse wave velocity
时间窗: At 7-9 years of age
Pulse wave velocity (neck to thigh) will be measured in meters per second
Waist circumference
时间窗: At 7-9 years of age
Measurements of waist circumference (in cm) will be assessed.
Blood lipids
时间窗: At 7-9 years of age
HDL-cholesterol in nmol/L will be assessed from a venous blood sample
Endothelial function
时间窗: At 7-9 years of age
Endothelial function will be assessed as reactive hyperemia (RH)-index
次要结局
未报告次要终点