StJustine's Hospital
Montreal, Quebec, H3T 1C5, Canada
NCT Number: NCT03261609
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.
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Notify Me18 year–29 year
All sexes
Observational
Montreal, Quebec, H3T 1C5, Canada
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:
(1) Socio-economic status: Occupation, education level and income of participant and parents. (2) Family history: Parental health (including maternal pregnancies) and familial (1st and 2nd degree) premature history of cardiovascular diseases (CVD), type-2 diabetes, chronic pulmonary or renal diseases. (3) Personal medical history: Current medication use (including anti-inflammatory medications), medical history, current symptoms, and growth parameters from birth to present (according to medical records and child health care booklet), age at menarche.
(4) Health-related behaviors: (a) regular physical activities (Minnesota and Huet validated questionnaires) (b) Smoking and alcohol consumption. (c) Diet assessed through the validated and self-administered 73-item Food Frequency Questionnaire (FFQ). (d) SF-36 Health Survey.
In addition to the study protocol, the subjects are invited to contribute extra biosamples to our blood (3 ml) and urine (1 ml) biobank.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
EPT :
Terms:
Exclusion criteria
Both groups :
The study compares young adult subjects born premature (< 29 weeks) versus term (-> 37 weeks)
Time frame: 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).
Time frame: 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).
Time frame: 1 hour
Urine 8-prostaglandin F2-alpha (pg/mL).
Time frame: 1 hour
Oxidized LDL (U/L)
Time frame: 1 hour
Blood pressure (mmHg)
Time frame: 30 min
Cardiac structure and function by echocardiography. Left ventricle hypertrophy determined by the LV mass (g) indexed to body surface area (BSA in m2) giving a unit of g/m2.
Time frame: 30 min
Cardiac structure and function by echocardiography. Left ventricle hypertrophy determined by the interventricular septum thickness (cm).
Time frame: 30 min
Cardiac structure and function by echocardiography. Left ventricle hypertrophy determined by LV dysfunction (%) or by endocardial fractional shortening (%)
Time frame: 1 hour
Arterial structure and function (mm) will be measured using a Dopller ultrasound.
Time frame: 15 min
Body mass index in kg/m2, calculating using the weight in kg and the height in m
Time frame: 30 min
Using lean and fat body (g) m
Time frame: 2 hours
Plasma fasting glucose (mmol/L) and insulin (mmol/L) and different times after a 75 g of glucose load.
Time frame: 1 hour
Plasma triglycerides (mmol/L), HDL (mmol/L) and LDL (mmol/L).
Time frame: 30 min
Urinary protein excretion (albumin/creatinine ratio, mg/mmol), eGFR cystatin C (cystatin C : mg/L) (mL/min/1.73 m2). The formula use the cystatin C values in mg/mL, the standardized serum cystatin min and max, the age (in years) and the sex (female: 0.932, male : 1).
Time frame: 15 min
Use of the eGFR cystatin C formula (cystatin C : mg/L) (mL/min/1.73 m2). The formula use the cystatin C values in mg/mL, the standardized serum cystatin min and max, the age (in years) and the sex (female: 0.932, male : 1).
Time frame: 30 min
FEV (%)
Time frame: 30 min
Airflow obstruction (FEV1/FVC ratio, no units).
Time frame: 2 hours
Determinants of health. Questionnaires about socio-economics status, family history, personal medical history.
Time frame: 2 hours
Determinants of health. Maternal obstetrical and subjects neonatal history.
Time frame: 2 hours
Determinants of health. Health-related behaviors
Time frame: 2 hours
Determinants of health. Food frequency questionnaire
St. Justine's Hospital
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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