Risk of Chronic Diseases in Young Adults Born Preterm: Relationship With Inflammation and Oxidative Stress Biomarkers.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Markers of oxydative stress in the urine
研究概览
简要总结
The purpose of the HAPI project is to study the overall health of preterm infants once they reach adulthood. The investigators would like to compare the health of adults born preterm with that of adults born full-term. They would also like to find the early signs, or biomarkers, of chronic diseases such as high blood pressure, diabetes, osteoporosis, and chronic lung diseases.
Such biomarkers would allow for early diagnosis and prevention. Furthermore, the investigators would like to understand why some people born preterm are more likely to develop chronic disease. They believe that inflammation and oxidative stress may play a part. Oxidative stress is present when the body is not able to defend itself against oxygen-derived products that can damage our cells.
To carry out this study, the investigators will examine 6 aspects of the health: (1) heart and circulation, (2) kidneys, (3) lungs, (4) metabolism - sugars and fats in the blood, (5) bones, and (6) eyes.
详细描述
The participants, from both groups will spend a whole day at St. Justine's hospital. Upon arrival after an overnight fast, vital signs and anthropometric measures are taken. Then blood and urine are obtained as well and a pregnancy test is performed for women. After inserting a intravenous catheter, around 55 mL of blood is taken and sent to the biochemistry department and to our laboratory. A oral glucose tolerance test is also performed with blood sampling over 2hours.
Then a renal and carotid ultrasounds, as well as a osteodensitometry test (bone mineral density and body muscle/fat composition) are done. Ophtalmology exam is realized by ophtalmologist, including visual acuity, contrast and fundus photograph, then the participants are provided with a standardized light lunch.
A thorough cardiac ultrasound, as well as assessment of major arteries (aorta, carotid, brachial) structure and function are performed. Pulmonary function tests are done before a fitness test for VO2 max, and repeated with bronchodilatator after the fitness test.
Prior to leaving, participants are given a ambulatory blood pressure monitor for them to carry for 24 consecutive hours over the following 2 days.
Prior to the study day, participants are sent questionnaires to be filled in advance by themselves and by each of their parent. During the study day, other questionnaires regarding their lifestyles and medical condition are also filled. Overall, information is obtained about:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 29 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Birth at GA<29 wks
- •Age 18-29 years at the time of assessment (age of peak human physiological function)
- •Birth at GA ≥37 wks
- •Born in Quebec, to account for health care access during pregnancy and throughout infancy/childhood
- •Birth date within 2 years of index case
- •Age 18-29 years at the time of assessment
- •Same self-reported race as preterm participant.
排除标准
- •Both groups :
- •Currently pregnant due to X-ray related risks
- •Severe neurosensory deficit preventing test completion.
- •In case of twins (or +), if both fulfil inclusion criteria, only one will selected (random) to participate to the study
结局指标
主要结局
Markers of oxydative stress in the urine
时间窗: 1 hour
Urine 8-prostaglandin F2-alpha (pg/mL).
Markers of inflammation
时间窗: 1 hour
Blood samples for measurements of biomarkers of inflammation are collected in the morning the day of the visit. Monocyte chemoattractant-1 (pg/mL), Interleukine-6 (pg/mL), tumor necrosis factor-alpha (pg/mL), intercellular adhesion molecule-1 (pg/mL), vascular cell adhesion molecule-1 (pg/mL), high-sensitivity C-reactive protein (pg/mL).
Markers of oxydative stress in the blood
时间窗: 1 hour
Blood samples for measurements of biomarkers of oxidative stress are collected in the morning the day of the visit. Blood : Glutathione (GSH and GSSG (nmol/mg of proteins)) and Redox potential using the Nernst equation and the values of GSH and GSSG (mV).
Markers of oxydative stress in the plasma
时间窗: 1 hour
Oxidized LDL (U/L)
次要结局
- CVD risk factors and indicators of (sub)clinical disease: glucose homeostasis(2 hours)
- CVD risk factors and indicators of (sub)clinical disease: Cardiac structure and function by echocardiography -LV hypertrophy #3(30 min)
- CVD risk factors and indicators of (sub)clinical disease: kidneys functions #1(30 min)
- CVD risk factors and indicators of (sub)clinical disease: Questionnaires #2(2 hours)
- CVD risk factors and indicators of (sub)clinical disease: Questionnaires #4(2 hours)
- CVD risk factors and indicators of (sub)clinical disease: Cardiac structure and function by echocardiography- LV hypertrophy #2(30 min)
- CVD risk factors and indicators of (sub)clinical disease: Questionnaires #3(2 hours)
- CVD risk factors and indicators of (sub)clinical disease: Cardiac structure and function by echocardiography- LV hypertrophy #1(30 min)
- CVD risk factors and indicators of (sub)clinical disease: Arterial structure and function by ultrasound.(1 hour)
- CVD risk factors and indicators of (sub)clinical disease: pulmonary functions #2(30 min)
- CVD risk factors and indicators of (sub)clinical disease: Questionnaires #1(2 hours)
- CVD risk factors and indicators of (sub)clinical disease: Fasting lipid profile(1 hour)
- CVD risk factors and indicators of (sub)clinical disease: kidneys functions #2(15 min)
- CVD risk factors and indicators of (sub)clinical disease: blood pressure(1 hour)
- CVD risk factors and indicators of (sub)clinical disease: Adiposity measures #1(15 min)
- CVD risk factors and indicators of (sub)clinical disease: Adiposity measures #2(30 min)
- CVD risk factors and indicators of (sub)clinical disease: pulmonary functions #1(30 min)
研究者
Anne Monique NUYT,MD
MD, Professor of Pediatrics
St. Justine's Hospital