Primary Objective: Prenatal and postnatal growth trajectories and prenatal maternale exposures, type of feeding, appetite regulating hormones and (epi)genetic factors in association with body composition at ages 1,3, 6 and 9 months and 1 year, 18…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
- Appetite and general nutritional disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters are body composition, anthropometric measurements and
metabolic health parameters in serum( e.g. serum lipids, satiety hormones),
saliva (satiety hormones) and stool.
Secondary outcome
Not applicable
Background summary
Preliminary data suggests that low birth weight for gestational age and rapid
postnatal catch-up growth are risk factors for the development of obesity and
diabetes type 2 in adulthood. It has been demonstrated that the early postnatal
period is a critical window for the programming of various pathways in tissues
and organs, in which nutrition is an important determinant. Up until now pilot
data show that rapid postnatal weight gain during the first 3 months of life
might cause accelerated fat accumulation which in turn will track into
adulthood, but until now it remained difficult to assess infant body
composition properly.
We hypothesize that unfavorable exposures during the early postnatal period
change programming of growth and metabolic pathways, thereby deranging infant*s
body composition, thereby increasing the risk for later obesity and diabetes
type 2.
Study objective
Primary Objective: Prenatal and postnatal growth trajectories and prenatal
maternale exposures, type of feeding, appetite regulating hormones and
(epi)genetic factors in association with body composition at ages 1,3, 6 and 9
months and 1 year, 18 months, 2 years an during the follow-up study at the age
of 3, 4, 5, 8, 10 and 12 years.
Secondary Objective: Infant*s fat mass accumulation in association with
metabolic biomarkers and health parameters, e.g. serum lipids, satiety
hormones, metabolic biomarkers and body composition, at the age of 2 years.
The most important goal of this study is to deliver more information about
healthy growth, for example to make new feeding guidelines, to prevent obesity.
Study design
Observational follow-up study of a birth cohort
Study burden and risks
Subjects will be included at birth, or within 2 weeks there after, in Erasmus
MC / Sophia and will visit the Erasmus MC / Sophia at 1, 3, 6, 9 months and 1
year, 18 months and 2 year.
In this period we will collect 6 blood samples, The total amount of blood drawn
will be limited because of special kits. With this kits a couple of drops of
blood is needed to measure a lot of hormones. Blood collection will be
conducted by trained staff.
At all visits, measurements such as anthropometrics and body composition will
be performed. Body composition will be measured using the PEA POD, a validated,
non-invasive, safe device. At 6 and 9 months body composition will be also
measured by Dual energy X-ray absorptiometry (DXA) scan, which gives very low
radiation exposure (approximately 0,0002 msV). Body composition and growth
measurements are safe and non-invasive.
During the FU-study, we will use the same priniple of air-displacement
plethysmography by BOD POD to investigate body composition in children of 3, 4,
5, 8, 10 and 12 years of age as well as DXA scans for comparison between these
two methods. Furthermore, the circadian rhythm will be investigated by an
activity tracker watch. Also stress levels will be measured by using hair
cortisol.
Wytemaweg 80
Rotterdam 3015CN
NL
Wytemaweg 80
Rotterdam 3015CN
NL
Listed location countries
Age
Inclusion criteria
- Healthy and full-term infants (gestational age >=37)
- Children with a neonatal period without severe asphyxia (defined as a Apgar
score <3 after 5 minutes), and no serious disease such as long-term artificial
ventilation and oxygen supply, broncho pulmonary dysplasia or other lung disease
-Written informed consent from both parents.Inclusion criteria follow-up Sophia
Pluto Study:
- participation in the Sophia Pluto Study during the first two years of life,
even if one or more visit(s) were not completed
- written informed consent from both parentsegeven
Exclusion criteria
- Maternal use of corticosteroids during pregnancy
- Pregnant women/parents known to have other significant medical condition
(including during pregnancy) that might interfere with the study or known to
affect intra-uterine growth as per investigator*s clinical judgment.
- Incapability of the parents to comply with study protocol
-Confirmed intra-uterine infection
-Infants with chromosomal disorders, known syndromes and serious dismorphic
symptoms suggestive for a (yet unknown) syndrome.
-Any endocrine or metabolic disorder such as diabetes mellitus, diabetes
insipidus, hypothyroidism, or inborn errors of metabolism
-Infants known to have current or previous illnesses/conditions or intervention
which could interfere with the study, such as certain medication (e.g. cortical
steroids) or major surgery, as per investigator*s clinical judgement.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL39625.078.12 |