Risk of Chronic Diseases in Young Adults Born Preterm: Relationship With Inflammation and Oxidative Stress Biomarkers.

Prematurity; Extreme Clinical Trial

Official title:

Risk of Chronic Diseases in Young Adults Born Preterm: Relationship With Inflammation and Oxidative Stress Biomarkers.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03261609
• Other study ID #: HAPI clinical project
• Status: Completed
• Start date: December 1, 2011
• Est. completion date: April 29, 2017

Study information

• Verified date: November 2022
• Source: St. Justine's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: April 29, 2017
• Est. primary completion date: March 29, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 29 Years

Eligibility

Inclusion Criteria:

EPT :

• Birth at GA<29 wks

• Age 18-29 years at the time of assessment (age of peak human physiological function)

Terms:

• 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.

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Chronic Disease
• Inflammation
• Prematurity; Extreme

Intervention

Other:
• preterm birth
The study compares young adult subjects born premature (< 29 weeks) versus term (-> 37 weeks)

Locations

Country	Name	City	State
Canada	StJustine's Hospital	Montréal	Quebec

Sponsors (3)

Lead Sponsor	Collaborator
St. Justine's Hospital	Jewish General Hospital, McGill University Health Centre/Research Institute of the McGill University Health Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Markers of inflammation	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).	1 hour
Primary	Markers of oxydative stress in the blood	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).	1 hour
Primary	Markers of oxydative stress in the urine	Urine 8-prostaglandin F2-alpha (pg/mL).	1 hour
Primary	Markers of oxydative stress in the plasma	Oxidized LDL (U/L)	1 hour
Secondary	CVD risk factors and indicators of (sub)clinical disease: blood pressure	Blood pressure (mmHg)	1 hour
Secondary	CVD risk factors and indicators of (sub)clinical disease: Cardiac structure and function by echocardiography- LV hypertrophy #1	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.	30 min
Secondary	CVD risk factors and indicators of (sub)clinical disease: Cardiac structure and function by echocardiography- LV hypertrophy #2	Cardiac structure and function by echocardiography. Left ventricle hypertrophy determined by the interventricular septum thickness (cm).	30 min
Secondary	CVD risk factors and indicators of (sub)clinical disease: Cardiac structure and function by echocardiography -LV hypertrophy #3	Cardiac structure and function by echocardiography. Left ventricle hypertrophy determined by LV dysfunction (%) or by endocardial fractional shortening (%)	30 min
Secondary	CVD risk factors and indicators of (sub)clinical disease: Arterial structure and function by ultrasound.	Arterial structure and function (mm) will be measured using a Dopller ultrasound.	1 hour
Secondary	CVD risk factors and indicators of (sub)clinical disease: Adiposity measures #1	Body mass index in kg/m2, calculating using the weight in kg and the height in m	15 min
Secondary	CVD risk factors and indicators of (sub)clinical disease: Adiposity measures #2	Using lean and fat body (g) m	30 min
Secondary	CVD risk factors and indicators of (sub)clinical disease: glucose homeostasis	Plasma fasting glucose (mmol/L) and insulin (mmol/L) and different times after a 75 g of glucose load.	2 hours
Secondary	CVD risk factors and indicators of (sub)clinical disease: Fasting lipid profile	Plasma triglycerides (mmol/L), HDL (mmol/L) and LDL (mmol/L).	1 hour
Secondary	CVD risk factors and indicators of (sub)clinical disease: kidneys functions #1	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).	30 min
Secondary	CVD risk factors and indicators of (sub)clinical disease: kidneys functions #2	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).	15 min
Secondary	CVD risk factors and indicators of (sub)clinical disease: pulmonary functions #1	FEV (%)	30 min
Secondary	CVD risk factors and indicators of (sub)clinical disease: pulmonary functions #2	Airflow obstruction (FEV1/FVC ratio, no units).	30 min
Secondary	CVD risk factors and indicators of (sub)clinical disease: Questionnaires #1	Determinants of health. Questionnaires about socio-economics status, family history, personal medical history.	2 hours
Secondary	CVD risk factors and indicators of (sub)clinical disease: Questionnaires #2	Determinants of health. Maternal obstetrical and subjects neonatal history.	2 hours
Secondary	CVD risk factors and indicators of (sub)clinical disease: Questionnaires #3	Determinants of health. Health-related behaviors	2 hours
Secondary	CVD risk factors and indicators of (sub)clinical disease: Questionnaires #4	Determinants of health. Food frequency questionnaire	2 hours