Determine the number of hypoglycemic events (fasting and postprandial) during post-bariatric pregnancies compared to non-bariatric pregnancies (with obese and healthy BMI) using continuous glucose monitoring and its effects on fetal growth.
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
- Foetal complications
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main endpoint is the number of hypoglycemic events (fasting and
postprandial) during post-bariatric pregnancies and non-bariatric pregnancies
(with obese and healthy BMI).
Secondary outcome
The secondary study parameters are neonatal birthweight, gestational weight
gain, placental weight and histology, micronutrient deficiency, and nu number
of hyperglycemic events. Other parameters are data from the patient file (age,
ethnicity, comorbidities, pre-bariatric weight).
Background summary
Current research suggests hypoglycemia is common in pregnancies after
metabolic-bariatric surgery (MBS) and may contribute to fetal growth (FG)
restrictions. However, the incidence of hypoglycemia is highly variable between
studies, and evidence for its effects on FG is limited. Previous research into
the extent in which hypoglycemia is responsible for FG restrictions after MBS
often does not determine whether the incidence of hypoglycemia differs between
trimesters, nor investigate other factors that might contribute to FG
restrictions, such as gestational weight gain (GWG), placental quality, and
post-BS micronutrient- and protein deficiencies. Additionally, more research
into the incidence of hyperglycemia during pregnancy after MBS is important, as
research suggests that it is increased in pregnancy after MBS.
Study objective
Determine the number of hypoglycemic events (fasting and postprandial) during
post-bariatric pregnancies compared to non-bariatric pregnancies (with obese
and healthy BMI) using continuous glucose monitoring and its effects on fetal
growth.
Study design
This study is a prospective observational study, using continuous glucose
monitoring.
Study burden and risks
The burden for the subjects consists of the following: During each trimester of
the pregnancy (at 12-14, 24 and 34 weeks), continuous glucose monitoring (CGM)
will be done for 7 days, a blood sample will be taken, and the patient is
weighted. Each subject will have 3 on site visits to place the CGM device.
During the CGM, patients will fill out a patient diary on symptoms of
hypoglycemia, food intake and daily activities. After the birth, the palcenta
is weighted. If the patient gives birth in the MCL, the placenta is send in for
histological analysis. The risk for the subjects is low. During this study, we
will determine the incidence of hypoglycemia in post-bariatric pregnancies and
its potential effects on FG. The findings of the study can help us better our
understanding of the effects of hypoglycemia on FG and thereby increase the
number of uncomplicated pregnancies after bariatric surgery.
Henri Dunantweg 2
Leeuwarden 8934 AD
NL
Henri Dunantweg 2
Leeuwarden 8934 AD
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all
of the following criteria: Pregnant, either after metabolic-bariatric surgery
(Roux-en-Y gastric bypass or One anastomosis gastric bypass performed at CON,
MCL with pre-surgery BMI >40, and post-BS total weight loss (TWL) of >20%), or
without metabolic-bariatric surgery with BMI >40 or BMI between 18.5-24.9. At
the time of inclusion, the subject must be between 6-10 weeks pregnant.
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
- Diagnosis with type 1 or type 2 diabetes before the pregnancy, or diagnosis
with type 1 or type 2 diabetes or GDM before the BS.
- Diagnosis with severe psychiatric or medical comorbidities known to
potentially affect fetal growth (e.g. severe depression, lupus, chronic kidney
disease).
- Continued smoking, alcohol consumption, or substance use throughout the
pregnancy.
- Allergy for plasters.
- Multiple pregnancy.
- Pregnancy less than 12 months after bariatric surgery.
- Post-bariatric total weight loss of <20%
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| CCMO | NL86830.099.24 |