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Obesity; EndocrineMOCARTNCT04924738

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

An observational study of Obesity; Endocrine and Pregnancy in Diabetic, run by Poznan University of Medical Sciences at 1 site in Poland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 45 years, women only
What is being tested?
Monitoring and lifestyle
How many people
200 participants
Where
1 sitePoland
Study dates
3 Dec 2017to Aug 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • No healthy volunteers
  • Adult

Study population: Tertiary level of perinatal care unit.

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Ewa Wender-Ożegowska, prof. contact

+4861859302

klinrozrod.gpsk.um@gmail.com

Poland1 site, 1 recruiting
  • Department of Reproduction, Poznan University of Medical Sciences

    Poznan, 60-535

    Ewa Wender-Ożegowska, prof., +4861659302, klinrozrod@gpsk.ump.edu.pl

    Recruiting

Other trials in Poland

About this study

Official title: 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.

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.

Being tested
Monitoring and lifestyle
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
Medical subject headings
Obesity, Pregnancy in Diabetics, Pediatric Obesity, Hypertension, Pregnancy-Induced, Disease, Gestational Weight Gain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Monitoring and lifestyleBehavioural

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

Study groups in NCT04924738
Study groupRoleWhat they receive
MOZART_SGWomen treated for hyperglycemia in pregnancy. Observational data are to be collected at follow-up visits during pregnancy, at delivery and postpartum.
Receives: Behavioral: Monitoring and lifestyle

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. maternal weight before delivery

    kg

    Measured: measured at term, within a week before delivery

  2. maternal weight in the early pregnancy

    kg

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

  3. birth weight

    g

    Measured: neonate's weight measured immediately after birth

Secondary outcomes (4)
  1. maternal blood pressure at the term

    mmHg

    Measured: measured at term, within a week before delivery

  2. average maternal fasting glucose at the term

    mg/dl

    Measured: measured seven times within two weeks before delivery

  3. average maternal postprandial glucose at the term

    mg/dl

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

  4. maternal HbA1c at the term

    percent [%]

    Measured: glycated haemoglobin measured within a month before delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jun 2021
  2. Study start3 Dec 2017
  3. Primary completionNov 2023 (estimated)
  4. Study completionAug 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04924738
Sponsor's protocol ID
102/19
Other IDs
525/17
Acronym
MOCART
Status last verified
Jun 2021
First submitted
7 Jun 2021
Last updated
14 Jun 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Mantaj U, Adamczak L, Wieckowska B, Sibiak R, Wender-Ozegowska E. The impact of FTO and ADRB3 gene variants, physical activity and proper diet on weight gain and perinatal outcomes in pregnant women with obesity. J Appl Genet. 2026 Aug 5. doi: 10.1007/s13353-026-01104-4. Online ahead of print.

    PubMed 42552455

Questions about this trial

What is this clinical trial studying?

An observational study of Obesity; Endocrine and Pregnancy in Diabetic, run by Poznan University of Medical Sciences at 1 site in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ewa Wender-Ożegowska, prof. (+4861859302, klinrozrod.gpsk.um@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

maternal weight before delivery (time frame: measured at term, within a week before delivery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04924738, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2021.

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