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Female Obesity Cohort and Intervention Study Group (MOCART Study Group) (MOCART)

7 czerwca 2021 zaktualizowane przez: Pawel Bogdanski, Poznan University of Medical Sciences

A Prospective Observational Trial of Factors Involved in the Intergenerational Transmission of the Non-communicable Disorders - Female Obesity Cohort and Intervention Study Group.

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.

Przegląd badań

Szczegółowy opis

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.

Typ studiów

Obserwacyjny

Zapisy (Oczekiwany)

200

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

      • Poznan, Polska, 60-535
        • Rekrutacyjny
        • Department of Reproduction, Poznan University of Medical Sciences
        • Kontakt:

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat do 45 lat (Dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Kobieta

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

Tertiary level of perinatal care unit.

Opis

Inclusion Criteria:

  • a woman in a singleton pregnancy referred to the Department of Reproduction, Poznan University of Medical Sciences
  • maternal BMI (body mass index): 27 kg/m2 or above
  • hyperglycemia detected in pregnancy according to the Polish Diabetes Association criteria, 2017
  • delivery in the University Hospital

Exclusion Criteria:

  • fetal malformation
  • any serious maternal conditions that might hamper patient's participation in the tiral

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Kohorty i interwencje

Grupa / Kohorta
Interwencja / Leczenie
MOZART_SG
Women treated for hyperglycemia in pregnancy. Observational data are to be collected at follow-up visits during pregnancy, at delivery and postpartum.
Dietary and lifestyle modification recommended for pregnant women with hyperglycemia detected in pregnancy.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
maternal weight before delivery
Ramy czasowe: measured at term, within a week before delivery
kg
measured at term, within a week before delivery
maternal weight in the early pregnancy
Ramy czasowe: measured after a viable pregnancy confirmed until a gestational age of 12 weeks
kg
measured after a viable pregnancy confirmed until a gestational age of 12 weeks
birth weight
Ramy czasowe: neonate's weight measured immediately after birth
g
neonate's weight measured immediately after birth

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
maternal blood pressure at the term
Ramy czasowe: measured at term, within a week before delivery
mmHg
measured at term, within a week before delivery
average maternal fasting glucose at the term
Ramy czasowe: measured seven times within two weeks before delivery
mg/dl
measured seven times within two weeks before delivery
average maternal postprandial glucose at the term
Ramy czasowe: measured one hour after main meals, twenty-one times within two weeks before delivery
mg/dl
measured one hour after main meals, twenty-one times within two weeks before delivery
maternal HbA1c at the term
Ramy czasowe: glycated haemoglobin measured within a month before delivery
percent [%]
glycated haemoglobin measured within a month before delivery

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Śledczy

  • Dyrektor Studium: Ewa Wender-Ożegowska, prof., Head of the Department of Reproduction

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

3 grudnia 2017

Zakończenie podstawowe (Oczekiwany)

1 listopada 2023

Ukończenie studiów (Oczekiwany)

1 sierpnia 2024

Daty rejestracji na studia

Pierwszy przesłany

7 czerwca 2021

Pierwszy przesłany, który spełnia kryteria kontroli jakości

7 czerwca 2021

Pierwszy wysłany (Rzeczywisty)

14 czerwca 2021

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

14 czerwca 2021

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

7 czerwca 2021

Ostatnia weryfikacja

1 czerwca 2021

Więcej informacji

Terminy związane z tym badaniem

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIEZDECYDOWANY

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

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