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

7. Juni 2021 aktualisiert von: 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.

Studienübersicht

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Voraussichtlich)

200

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

      • Poznan, Polen, 60-535
        • Rekrutierung
        • Department of Reproduction, Poznan University of Medical Sciences
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 45 Jahre (Erwachsene)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Weiblich

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

Tertiary level of perinatal care unit.

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
maternal weight before delivery
Zeitfenster: measured at term, within a week before delivery
kg
measured at term, within a week before delivery
maternal weight in the early pregnancy
Zeitfenster: 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
Zeitfenster: neonate's weight measured immediately after birth
g
neonate's weight measured immediately after birth

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
maternal blood pressure at the term
Zeitfenster: measured at term, within a week before delivery
mmHg
measured at term, within a week before delivery
average maternal fasting glucose at the term
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: glycated haemoglobin measured within a month before delivery
percent [%]
glycated haemoglobin measured within a month before delivery

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Ermittler

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

3. Dezember 2017

Primärer Abschluss (Voraussichtlich)

1. November 2023

Studienabschluss (Voraussichtlich)

1. August 2024

Studienanmeldedaten

Zuerst eingereicht

7. Juni 2021

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

7. Juni 2021

Zuerst gepostet (Tatsächlich)

14. Juni 2021

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

14. Juni 2021

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

7. Juni 2021

Zuletzt verifiziert

1. Juni 2021

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Plan für individuelle Teilnehmerdaten (IPD)

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UNENTSCHIEDEN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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