Primary :To compare diet quality and nutrient status before and during pregnancy of women who develop GDM with those who have normal blood sugar levelsSecondary:*To compare body composition before (and during) pregnancy of women who develop GDM with…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Dutch Healthy Diet index score which is a measure of overall diet quality
Secondary outcome
Nutrient status for vitamin D, folic acid, vitamin B12, vitamin B6 and iron
Dietary intake of food groups, individual foods, macronutrients and
micronutrients
BMI (weight and height)
Body fat percentage
Physical activity level
Cardiometabolic risk factors (blood pressure, serum total and HDL cholesterol,
triglycerides, liver enzymes [CRP, ALAT, ASAT, AF and GTT])
Adiponectin and other adipokines (e.g. leptin)
Background summary
Gestational diabetes mellitus (GDM) is one of the most common metabolic
complication during pregnancy, affecting 1-18% of all pregnancies. GDM
increases risk of adverse pregnancy outcomes and has been related to
significant short-term and long-term adverse health outcomes for both mothers
and offspring, including increased risk of adverse pregnancy outcomes, type 2
diabetes and obesity. Although treatment is effective in reducing adverse
pregnancy outcomes, prevention might be more desirable as this might be more
effective in reducing long term adverse health outcomes. Diet is often linked
as modifiable risk factor to GDM, however there is still a knowledge gap
regarding the association between diet and GDM. This needs to be addressed
before designing prevention intervention studies.
Study objective
Primary :
To compare diet quality and nutrient status before and during pregnancy of
women who develop GDM with those who have normal blood sugar levels
Secondary:
*To compare body composition before (and during) pregnancy of women who develop
GDM with those who have normal blood sugar levels
*To compare physical activity level before and during pregnancy of women who
develop GDM with those who have normal blood sugar levels
*To compare cardiometabolic risk factors and adipokines before and during
pregnancy of women who develop GDM with those who have normal blood sugar
levels
Study design
This is an observational study using a whole pregnancy approach to assess the
association between diet and GDM. This includes measurements before the
pregnancy, measurements during pregnancy (at 12 weeks of gestation and at 24
weeks of gestation) and after pregnancy (6 weeks after delivery). Every
measurement moment consists of a physical examination, blood sampling + an oral
glucose tolerance, several questionnaires assessing dietary intake, eating
behaviour, physical activity, medical history and quality of life , two times
filling in a 24-hour recall, collecting 24 hour urine and wearing a
accelerometer for 7 consecutive days. Additionally at the first measurement
moment a DXA-scan is done to measure body fat percentage.
In a substudy umbilical cord blood, a piece of the umibilcal cord and a buccal
swap of the child (at age 6-9 weeks) will be collected These measurements will
allow us to investigate the effect of gestational diabetes on the epigenome of
the child.
Study burden and risks
Subjects will be asked for 4 visits to the study centre (approximately 30
minutes per examination), 4 visits to one of the involved hospitals (120
minutes per visit), 8 times filling in a 24-hour recall (30 minutes per
recall), wearing 4 times a week an accelerometer and collecting 4 times 24 hour
urine.
Venapunctures can occasionally cause a local hematoma or bruise and some
participants may report pain or discomfort. Measurement of body fat percentage
at T0 will be done using DXA. This procedure uses a very low dose of X-ray,
comparable to that of skiing or walking half a day in the mountains.
Benefit for the individual participants is that they receive information on
their BMI, blood pressure, total and HDL-cholesterol, triglyceride and glucose
level, with interpretation based on the guidelines of Dutch general
practitioners (NHG-standaard), and the advice to contact their general
practitioner when values are to be considered high.
Substudy: collection of umbilical cord blood, a piece of umbilical cord and a
buccal swap are considered non-invasive and safe for both mother and child.
Bomenweg 4
Wageningen 6703 HD
NL
Bomenweg 4
Wageningen 6703 HD
NL
Listed location countries
Age
Inclusion criteria
*Female
*Age from 18 -40
*Pregnancy wish (wants to get pregnant within one year at time of recruitment) OR * 24 weeks pregnant at time of recruitment
*Competent to make own decisions
*Written informed consent obtained
Exclusion criteria
*Not able to read and speak Dutch
*>24 weeks pregnant at time of recruitment
*Type 1 diabetes mellitus
*Type 2 diabetes mellitus
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 | NL50554.081.14 |