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.
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
- Conditions the study is for
- Obesity; Endocrine, Pregnancy in Diabetic, Child Obesity
- What is being tested?
- Monitoring and lifestyle
- Type of treatment
- Lifestyle or therapy programme
- 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.
Poland1 site, 1 recruiting
- Recruiting
Department of Reproduction, Poznan University of Medical Sciences
Poznan, 60-535
Ewa Wender-Ożegowska, prof., +4861659302, klinrozrod@gpsk.ump.edu.pl
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 group | Role | What they receive |
|---|---|---|
| MOZART_SG | Women 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.
maternal weight before delivery
kg
Measured: measured at term, within a week before delivery
maternal weight in the early pregnancy
kg
Measured: measured after a viable pregnancy confirmed until a gestational age of 12 weeks
birth weight
g
Measured: neonate's weight measured immediately after birth
Secondary outcomes (4)
maternal blood pressure at the term
mmHg
Measured: measured at term, within a week before delivery
average maternal fasting glucose at the term
mg/dl
Measured: measured seven times within two weeks before delivery
average maternal postprandial glucose at the term
mg/dl
Measured: measured one hour after main meals, twenty-one times within two weeks before delivery
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.
- First posted14 Jun 2021
- Study start3 Dec 2017
- Primary completionNov 2023 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obesity; EndocrineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Poznan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pawel Bogdanski, Poznan University of Medical Sciences
- Investigators
- Ewa Wender-Ożegowska, prof., Study director, Head of the Department of Reproduction
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
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04924738
- Acronym / sponsor ID
- MOCART / 102/19
- 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
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Poznan University of Medical SciencesUniversity, hospital or other
- Study start
- 3 Dec 2017 (actual)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 14 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MOZART_SG | – | Behavioral: Monitoring and lifestyleWomen treated for hyperglycemia in pregnancy. Observational data are to be collected at follow-up visits during pregnancy, at delivery and postpartum. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Tertiary level of perinatal care unit.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- fetal malformation
- any serious maternal conditions that might hamper patient's participation in the tiral
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Monitoring and lifestyleDietary and lifestyle modification recommended for pregnant women with hyperglycemia detected in pregnancy. | Behavioural | MOZART_SG |
Primary outcome
maternal weight before delivery
Time frame: measured at term, within a week before delivery
kg
maternal weight in the early pregnancy
Time frame: measured after a viable pregnancy confirmed until a gestational age of 12 weeks
kg
birth weight
Time frame: neonate's weight measured immediately after birth
g
4 secondary outcomes
maternal blood pressure at the term
Time frame: measured at term, within a week before delivery
average maternal fasting glucose at the term
Time frame: measured seven times within two weeks before delivery
average maternal postprandial glucose at the term
Time frame: measured one hour after main meals, twenty-one times within two weeks before delivery
maternal HbA1c at the term
Time frame: glycated haemoglobin measured within a month before delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2021.
- Derived from this study: PubMed 42552455Mantaj 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ewa Wender-Ożegowska, prof. study director
Head of the Department of Reproduction
1 site in 1 country: see every site and its status.
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.