To investigate the effect of distracted consumption on glucose variability in women with GDM and to investigate moderating effects of type of distractor and perceived stress.
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Glucose profiles in response to meals eaten with and without distraction.
Secondary outcome
• type of distractor
• perceived stress
Background summary
Gestational diabetes mellitus (GDM) is defined as diabetes diagnosed in the
second or third trimester of pregnancy that was not clearly overt diabetes
prior to gestation. GDM is associated with adverse outcomes for mother and
child. Women with GDM have greater blood glucose fluctuation or glycemic
variability (GV), which is a strong predictor of complications for both the
child and the mother, during and after delivery. In this study, we propose that
not only the amount and contents of food affect GV but eating manners (with or
without distraction) may also affect GV in GDM. Nowadays, people pay less and
less attention to their meals, often engaging in other activities
simultaneously. Since mental capacity is limited, this resulted in less sensory
information such as taste. This decreased sensory processing due to distracted
consumption may dysregulate the glucose-insulin signalling pathway, resulting
in (mild) hyperglycemia and increased GV. In women with GDM post-prandial
glucose levels and GV are higher than in people with normal glucose tolerance.
This may make women with GDM more susceptible to the dysregulating effects of
distracted consumption, which might further exaggerate GV and post-prandial
hyperglycemia and increase the risk for negative health outcomes for mother and
child.
Study objective
To investigate the effect of distracted consumption on glucose variability in
women with GDM and to investigate moderating effects of type of distractor and
perceived stress.
Study design
Observational study. Participants eat a standardized snack at the lab two
times, one meal with distraction, completing a computer task, and one meal
without distraction. During the meals, glucose levels will be monitored using
continuous glucose monitoring (CGM). In the week in between the lab visits,
glucose levels will be measured with CGM and distractions during meals and meal
content will be measured via a questionnaire filled out via smartphone.
Study burden and risks
This type of paradigm poses no significant risk. Participants monitor their
blood glucose levels with a finger stick as part of their regular treatment,
for this study they will be asked to do this two additional times. Furthermore,
participants will have a snack in the lab during two lab visits (30 min per
session). This snack consists of two cereal bars containing a total of 30 g of
carbohydrates including 6 g sugar. This particular snack has been carefully
chosen by a dietician to provide a slight increase in blood glucose levels. In
comparison to the oral glucose tolerance test used for diagnosing GDM, which
contains 75 grams of sugar, this snack contains relatively low amounts of sugar
and carbohydrates and would fit in a normal diet. Additionally, glucose levels
will be monitored using continuous glucose monitoring (CGM), consisting of a
sensor inserted under their skin, on the arm, using an automatic inserter. The
sensor measures interstitial glucose level. This technique is already
implemented in routine care for patients with insulin use, also in pregnancy,
furthermore it is painless and does not pose any substantial risks. Finally,
participants will fill out some short questions via their smartphone. In
summary, the risk associated with participation is assessed as low and the
burden as minimal.
Wassenaarseweg 52 100
Leiden 2333AK
NL
Wassenaarseweg 52 100
Leiden 2333AK
NL
Listed location countries
Age
Inclusion criteria
• Have been diagnosed with gestational diabetes mellitus in the second or third
trimester of pregnancy
• Have given their written informed consent
• Above 18 years old
• Fluent in Dutch or English
Exclusion criteria
• Insulin or oral glucose lowering drug use
• Daily smoking
• Multiple pregnancy
• History of medical or surgical interventions that may affect metabolism or
glucose management
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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In other registers
Register | ID |
---|---|
CCMO | NL82443.058.22 |