Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04924738 |
| Other study ID # |
102/19 |
| Secondary ID |
525/17 |
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
December 3, 2017 |
| Est. completion date |
August 2024 |
Study information
| Verified date |
June 2021 |
| Source |
Poznan University of Medical Sciences |
| Contact |
Ewa Wender-Ozegowska, prof. |
| Phone |
+4861859302 |
| Email |
klinrozrod.gpsk.um[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
This prospective observational trial includes women with high risk pregnancies complicated
with hyperglycemia in pregnancy and excessive body weight. The participants are enrolled when
pregnant and monitored throughout pregnancy and delivery until the offspring is 6 months old.
This research addresses the question which risk factors for non-communicable disorders such
as hypertension, obesity, type 2 diabetes for a woman and her offspring can be detected
during pregnancy and in early childhood.
Description:
The available epidemiological data clearly indicate a significant increase in the percentage
of people with obesity and the metabolic syndrome in the population of women of reproductive
age. These diseases predispose to the onset of type 2 diabetes at a young age and accelerate
the risk of cardiovascular diseases, while in pregnant population they constitute a serious
risk factor for gestational diabetes.
Recent decades have brought a growing amount of evidence from prospective studies indicating
the adverse impact of gestational diabetes on the health prognosis of the mother and her
child. In the short-term perspective, hyperglycemia in pregnancy constitutes a risk factor
for numerous maternal-fetal complications, in particular hypertensive diseases in pregnancy,
excessive fetal growth, intrapartum complications induced by excessive birth weight of the
newborn, which can result in intrapartum neonatal asphyxia or maternal postpartum
haemorrhage. Gestational diabetes is also associated with an increased risk of fetal
intrauterine death in late pregnancy, during delivery or postpartum.
However, there is growing evidence of the adverse effects of gestational diabetes on
long-term health outcomes of the mother and her offspring, even when glucose tolerance
disorders are resolved after delivery. Hyperglycemia detected in pregnancy is a strong risk
factor for the development of type 2 diabetes within several years after experiencing a
complicated pregnancy. Moreover, maternal hyperglycemia has been shown to adversely affect
the long-term risk of obesity, metabolic syndrome, pre-diabetes, and type 2 diabetes in the
offspring of this pregnant population. This relationship is so clear that it is the exposure
of the fetus to the abnormal intrauterine metabolic environment that is considered to be one
of the leading causes of the significantly increased prevalence of the aforementioned
civilization diseases among children and adolescents.
The authors of the study expect that the obtained results will provide important data
enabling early identification of the population that can benefit most measurably from the
diagnosis and possible treatment of conditions predisposing to the non-communicable diseases.
The authors believe, that this study will identify specific maternal characteristics that
could be targets for individualized interventions modifying risk factors of civilization
diseases in mothers and their offspring. The authors expect that the measurable effect of the
research will be achievable in the short term - in the form of reduction of maternal-fetal
complications characteristic of pregnancy complicated with obesity and / or gestational
diabetes (maternal "diabesity"), and in the long term - in the form of improvement of the
incidence rates of non-communicable disorders in the population of pregnant women of a risk
profile similar to this presented by the cohort included in the study.
Research objectives:
- identification of epigenetic risk factors of intergenerational glucose tolerance
disorders and examining the possibility of their modification so as to break the
intergenerational "vicious circle" of metabolic syndrome and lifestyle diseases
resulting from it;
- identification of mechanisms responsible for the intergenerational transmission of
classic and "new" risk factors of non-communicable diseases;
- gather information for future trials on development and evaluation of interventions
aimed at reducing the effects of the intergenerational "vicious circle" of obesity,
insulin resistance and diseases related to lifestyle.
The protocol includes the following visits:
V0 - recruitment, V1 - gestational age 28-32 weeks, V2 - gestational age 36-38 weeks, V3 -
delivery, V4 - six weeks postpartum, V5 - six months postpartum
At the V0, the researchers will collect detailed information concerning demographics,
anthropometrics, past diseases, pregnancy-related conditions, lifestyle and dietary habits
At the V1, V2, V4 and V5, the researchers collect data regarding maternal glucose levels and
body weight, perform noninvasive tests of cardiovascular function and collect biological
material to be aliquoted, frozen and stored for further examination of biomarkers of
oxidative stress, fat tissue function, inflammation, insulin resistance, clotting system,
cardiometabolic risk; also information regarding fetal growth (V1,V2) and child's
anthropometrics and development (V4, V5) will be collected.
At the V3, the researchers collect a detailed information regarding delivery and neonatal
anthropometrics, and collect samples of placenta and cord blood to be aliquoted, frozen and
stored for further examination (see above).
At the V6, the researchers collect information regarding maternal dietary and lifestyle
habits, perform noninvasive tests of cardiovascular function and collect biological material
to be aliquoted, frozen and stored for further examination of biomarkers of oxidative stress,
fat tissue function, inflammation, insulin resistance, clotting system, cardiometabolic risk.
