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Status unknownNCT04924738MOCARTUpdated Jun 14, 2021

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

An observational study in Obesity; Endocrine, Pregnancy in Diabetic and Child Obesity, sponsored by Poznan University of Medical Sciences. Status unknown at 1 site in Poland. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2021-06-14.

Sponsored by Poznan University of Medical Sciences · Observational

The sponsor has not verified this record recently (last verified Jun 2021), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
18 Years to 45 Years
Sex
Female
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Study 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.

Read the detailed 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.

02

Conditions studied

  • Obesity; Endocrine
  • Pregnancy in Diabetic
  • Child Obesity
  • Hypertension in Pregnancy

Keywords

  • DOHaD - developmental origins of health and disease
  • hyperglycemia in pregnancy
  • gestational weight gain
  • adipokines
  • endothelium dysfunction
  • large for gestational age
  • macrosomia
  • early life origins of health and disease
03

In context

Hypertension, Pregnancy-Induced

240 studies on the registry are indexed under Hypertension, Pregnancy-Induced; 66 are open to participants now.

This study's planned enrollment of 200 is below the median of 225 across 68 observational studies indexed under Hypertension, Pregnancy-Induced.

Browse Hypertension, Pregnancy-Induced studies →

Lead sponsor

Poznan University of Medical Sciences is the lead sponsor of 143 studies on the registry; 46 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Tertiary level of perinatal care unit.

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

Exclusion Criteria:

  • fetal malformation
  • any serious maternal conditions that might hamper patient's participation in the tiral
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • MOZART_SG

    Women treated for hyperglycemia in pregnancy. Observational data are to be collected at follow-up visits during pregnancy, at delivery and postpartum.

    Behavioral: Monitoring and lifestyle

Interventions

  • BehavioralMonitoring and lifestyle

    Dietary and lifestyle modification recommended for pregnant women with hyperglycemia detected in pregnancy.

06

What researchers measure

Primary outcomes

  1. maternal weight before delivery

    kg

    Time frame: measured at term, within a week before delivery

  2. maternal weight in the early pregnancy

    kg

    Time frame: measured after a viable pregnancy confirmed until a gestational age of 12 weeks

  3. birth weight

    g

    Time frame: neonate's weight measured immediately after birth

Secondary outcomes

  1. maternal blood pressure at the term

    mmHg

    Time frame: measured at term, within a week before delivery

  2. average maternal fasting glucose at the term

    mg/dl

    Time frame: measured seven times within two weeks before delivery

  3. average maternal postprandial glucose at the term

    mg/dl

    Time frame: measured one hour after main meals, twenty-one times within two weeks before delivery

  4. maternal HbA1c at the term

    percent \[%\]

    Time frame: glycated haemoglobin measured within a month before delivery

07

Study locations

1 of 1 sites recruiting
  • Department of Reproduction, Poznan University of Medical Sciences
    Poznan, 60-535, Poland
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 14, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04924738
Lead sponsor
Poznan University of Medical Sciences
Responsible party
Pawel Bogdanski (Director of the Department of Treatment of Obesity, Metabolic Disorders and Clinical Dietetics, Poznan University of Medical Sciences) — Principal investigator
First posted
Jun 14, 2021
Start date
Dec 3, 2017
Primary completion
Nov 2023 (estimated)
Completion
Aug 2024 (estimated)
Last update
Jun 14, 2021

Study contacts

Ewa Wender-Ożegowska, prof.
Contact
klinrozrod.gpsk.um@gmail.com
+4861859302
Ewa Wender-Ożegowska, prof.
study director · Head of the Department of Reproduction

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.

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