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

7 giugno 2021 aggiornato da: 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.

Panoramica dello studio

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Anticipato)

200

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

      • Poznan, Polonia, 60-535
        • Reclutamento
        • Department of Reproduction, Poznan University of Medical Sciences
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 45 anni (Adulto)

Accetta volontari sani

No

Sessi ammissibili allo studio

Femmina

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

Tertiary level of perinatal care unit.

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
maternal weight before delivery
Lasso di tempo: measured at term, within a week before delivery
kg
measured at term, within a week before delivery
maternal weight in the early pregnancy
Lasso di tempo: 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
Lasso di tempo: neonate's weight measured immediately after birth
g
neonate's weight measured immediately after birth

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
maternal blood pressure at the term
Lasso di tempo: measured at term, within a week before delivery
mmHg
measured at term, within a week before delivery
average maternal fasting glucose at the term
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: glycated haemoglobin measured within a month before delivery
percent [%]
glycated haemoglobin measured within a month before delivery

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Direttore dello studio: Ewa Wender-Ożegowska, prof., Head of the Department of Reproduction

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

3 dicembre 2017

Completamento primario (Anticipato)

1 novembre 2023

Completamento dello studio (Anticipato)

1 agosto 2024

Date di iscrizione allo studio

Primo inviato

7 giugno 2021

Primo inviato che soddisfa i criteri di controllo qualità

7 giugno 2021

Primo Inserito (Effettivo)

14 giugno 2021

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

14 giugno 2021

Ultimo aggiornamento inviato che soddisfa i criteri QC

7 giugno 2021

Ultimo verificato

1 giugno 2021

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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