Clinical trial NCT05174728: Innovations in Placental Metabolism and Association With Antioxidants and Nutrients in Diabetes and Gestational Obesity
Official title: Innovations in Placental Metabolism and Association With Antioxidants and Nutrients in Diabetes and Gestational Obesity
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Pregnancy Complications
Obesity, Maternal
Diabetes Mel Gestational - in Pregnancy
Keywords: pregnancy
gestational diabetes mellitus
pre-gestational maternal obesity
Lead sponsor: Rio de Janeiro State University
Sponsor class: OTHER
Collaborators: name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
name: Rio de Janeiro State Research Supporting Foundation (FAPERJ)
name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
name: University of Cambridge
name: Université Montpellier
name: Universidade Federal do Rio de Janeiro
name: Maternidade Escola da UFRJ
First posted: 2022-01-03
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consists of pregnant women with a single fetus, aged between 18-45 years who attended prenatal care at the Maternity School at Federal University of Rio de Janeiro. The study group includes healthy pregnant women, pregnant women with obesity and gestational diabetes mellitus associated or not with obesity.

Brief summary: This research project aims to investigate, in an innovative way, the molecular pathophysiology of gestational complications induced by maternal obesity and gestational diabetes mellitus (GDM). These complications have an immediate impact on obstetric outcomes - such as pre-eclampsia and intrauterine growth restriction - as well as long-term consequences for the health of the mother and child. This proposal aims to advance the understanding of the relationship between subclinical maternal and placental inflammation with dietary components through a prospective cohort of pregnant women. To this end, a prospective cohort of pregnant women will be conducted with four follow-up waves: 13th-20th (baseline), 24th-28th, 32nd-36th gestational weeks and at the time of delivery. Retrospective data referring to the first trimester of pregnancy will be obtained from the medical records. Pregnant women will be invited to participate in the study by registering at the prenatal service. Women who start prenatal care with less than 13 weeks of gestation will be registered, for capture in the 2nd consultation. The initial sample calculation is 120 volunteers. Maternal blood samples will be collected at 2 times: 2nd trimester appointment and 3rd trimester appointment. Placental and umbilical cord blood samples will be collected immediately after delivery. Dietary consumption during pregnancy will be assessed by 2 24-hour recalls at each visit (1 in person and 1 by telephone). The identification of functional biomarkers in maternal blood and placenta will serve for prognostic purposes of gestational complications such as Gestational Diabetes Mellitus. The identification of dietary factors associated with obesity and gestational diabetes mellitus and associated complications will provide information that will serve as a basis for nutritional guidelines for pregnant women.


Eligibility criteria: Inclusion Criteria:

* Age between 18 and 45 years;
* Free from chronic non-communicable diseases such as high blood pressure and type 2 diabetes mellitus, except obesity;
* Free from infectious diseases;
* Carrying a single fetus;
* Intention to deliver at Maternity School-Federal University of Rio de Janeiro

Exclusion Criteria:

* Smokers;
* With low weight in early pregnancy (BMI \< 18.5 kg/m²). They will be verified by interview, before the signing the informed consent form.

Primary outcomes:
measure: Maternal redox homeostasis
timeFrame: between 24th and 28th gestational week
measure: Maternal redox homeostasis [change]
timeFrame: between 34th and 35th gestational week
measure: Fetal (cord blood) redox homeostasis
timeFrame: At delivery
measure: Placental redox homeostasis
timeFrame: At delivery
measure: Maternal inflammatory profile
timeFrame: between 24th and 28th gestational week
measure: Maternal inflammatory profile [change]
timeFrame: between 34th and 35th gestational week
measure: Fetal (cord blood) inflammatory profile
timeFrame: At delivery
measure: Placental inflammatory profile
timeFrame: At delivery
measure: Maternal metabolic profile
timeFrame: between 24th and 28th gestational week
measure: Maternal metabolic profile [change]
timeFrame: between 34th and 35th gestational week
measure: Fetal (cord blood) metabolic profile
timeFrame: At delivery
measure: Placental metabolic profile
timeFrame: At delivery
measure: Placental mitochondrial function at delivery
timeFrame: At delivery
Secondary outcomes:
measure: Placental lipid metabolism
timeFrame: At delivery
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Maternidade Escola da UFRJ
Study officials:
affiliation: UFRJ
name: Tatiana El-Bacha, DSc
role: PRINCIPAL_INVESTIGATOR
affiliation: UFRJ
name: Carolina S Ferreira, DSc
role: STUDY_CHAIR
affiliation: UFRJ
name: Deborah AB Guimarães, DSc
role: STUDY_CHAIR
affiliation: UFRJ
name: Gabriela DA Pinto, DSc
role: STUDY_CHAIR
affiliation: UFRJ
name: Vanessa A Goes, DSc
role: STUDY_CHAIR
References: