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

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.

Study Overview

• Status: Recruiting
• Conditions: Hypertension in Pregnancy; Child Obesity; Pregnancy in Diabetic; Obesity; Endocrine
• Intervention / Treatment: Behavioral: Monitoring and lifestyle

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 Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Ewa Wender-Ożegowska, prof.; Phone Number: +4861859302; Email: klinrozrod.gpsk.um@gmail.com

Study Locations

• Poland
  • Poznan, Poland, 60-535
    • Recruiting
    • Department of Reproduction, Poznan University of Medical Sciences
    • Contact: Ewa Wender-Ożegowska, prof.; Phone Number: +4861659302; Email: klinrozrod@gpsk.ump.edu.pl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Tertiary level of perinatal care unit.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Dietary and lifestyle modification recommended for pregnant women with hyperglycemia detected in pregnancy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
maternal weight before delivery	kg	measured at term, within a week before delivery
maternal weight in the early pregnancy	kg	measured after a viable pregnancy confirmed until a gestational age of 12 weeks
birth weight	g	neonate's weight measured immediately after birth

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
maternal blood pressure at the term	mmHg	measured at term, within a week before delivery
average maternal fasting glucose at the term	mg/dl	measured seven times within two weeks before delivery
average maternal postprandial glucose at the term	mg/dl	measured one hour after main meals, twenty-one times within two weeks before delivery
maternal HbA1c at the term	percent [%]	glycated haemoglobin measured within a month before delivery

Collaborators and Investigators

• Sponsor: Poznan University of Medical Sciences
• Investigators: Study Director: Ewa Wender-Ożegowska, prof., Head of the Department of Reproduction

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2017
• Primary Completion (Anticipated): November 1, 2023
• Study Completion (Anticipated): August 1, 2024

Study Registration Dates

• First Submitted: June 7, 2021
• First Submitted That Met QC Criteria: June 7, 2021
• First Posted (Actual): June 14, 2021

Study Record Updates

• Last Update Posted (Actual): June 14, 2021
• Last Update Submitted That Met QC Criteria: June 7, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: gestational weight gain; large for gestational age; macrosomia; adipokines; DOHaD - developmental origins of health and disease; hyperglycemia in pregnancy; endothelium dysfunction; early life origins of health and disease
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Pregnancy Complications; Hypertension; Obesity; Pediatric Obesity; Pregnancy in Diabetics; Hypertension, Pregnancy-Induced
• Other Study ID Numbers: 102/19; 525/17 (Other Identifier: Poznan University of Medical Sciences - Bioethics Board)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No