Innovations in Placental Metabolism and Association With Antioxidants and Nutrients in Diabetes and Gestational Obesity

NCT05174728 | Suspended

• 1 other identifier: 66949217.0.0000.5275
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy Complications; Obesity, Maternal; Diabetes Mel Gestational - in Pregnancy

Keywords

pregnancy; gestational diabetes mellitus; pre-gestational maternal obesity

Outcome Measures

Primary Outcomes (13)

• Maternal redox homeostasis

  Redox homeostasis will be assessed in maternal blood using a biological assay to measure the capacity of the sample to prevent the oxidation of a known fluorescence probe, in the presence of an oxidant. The unit of measure is concentration of plasma expressed as equivalent to a know antioxidant (after performing a calibration curve).

  between 24th and 28th gestational week

• Maternal redox homeostasis [change]

  Redox homeostasis will be assessed in maternal blood using a biological assay to measure the capacity of the sample to prevent the oxidation of a known fluorescence probe, in the presence of an oxidant. The unit of measure is concentration of plasma expressed as equivalent to a know antioxidant (after performing a calibration curve).

  between 34th and 35th gestational week

• Fetal (cord blood) redox homeostasis

  Redox homeostasis will be assessed in maternal blood using a biological assay to measure the capacity of the sample to prevent the oxidation of a known fluorescence probe, in the presence of an oxidant. The unit of measure is concentration of plasma expressed as equivalent to a know antioxidant (after performing a calibration curve).

  At delivery

• Placental redox homeostasis

  Redox homeostasis will be assessed in maternal blood using a biological assay to measure the capacity of the sample to prevent the oxidation of a known fluorescence probe, in the presence of an oxidant. The unit of measure is concentration of plasma expressed as equivalent to a know antioxidant (after performing a calibration curve).

  At delivery

• Maternal inflammatory profile

  Inflammatory profile will be assessed in maternal blood using a commercial kit to measure cytokines using ELISA assay, expressed as concentration per volume of sample.

  between 24th and 28th gestational week

• Maternal inflammatory profile [change]

  Inflammatory profile will be assessed in maternal blood using a commercial kit to measure cytokines using ELISA assay, expressed as concentration per volume of sample.

  between 34th and 35th gestational week

• Fetal (cord blood) inflammatory profile

  Inflammatory profile will be assessed in maternal blood using a commercial kit to measure cytokines using ELISA assay, expressed as concentration per volume of sample.

  At delivery

• Placental inflammatory profile

  Inflammatory profile will be assessed in maternal blood using a commercial kit to measure cytokines using ELISA assay, expressed as concentration per volume of sample.

  At delivery

• Maternal metabolic profile

  Metabolic profile will be assesses in maternal blood using Nuclear Magnetic Resonance metabolomics which measure small molecules (\<1,500 Da) in the biological sample. The unit is intensity of the peak measured in a known volume/mass of sample obtained from the nuclear magnetic resonance spectra

  between 24th and 28th gestational week

• Maternal metabolic profile [change]

  Metabolic profile will be assesses in maternal blood using Nuclear Magnetic Resonance metabolomics which measure small molecules (\<1,500 Da) in the biological sample. The unit is intensity of the peak measured in a known volume/mass of sample obtained from the nuclear magnetic resonance spectra

  between 34th and 35th gestational week

• Fetal (cord blood) metabolic profile

  Metabolic profile will be assesses in maternal blood using Nuclear Magnetic Resonance metabolomics which measure small molecules (\<1,500 Da) in the biological sample. The unit is intensity of the peak measured in a known volume/mass of sample obtained from the nuclear magnetic resonance spectra

  At delivery

• Placental metabolic profile

  Metabolic profile will be assesses in maternal blood using Nuclear Magnetic Resonance metabolomics which measure small molecules (\<1,500 Da) in the biological sample. The unit is intensity of the peak measured in a known volume/mass of sample obtained from the nuclear magnetic resonance spectra

  At delivery

• Placental mitochondrial function at delivery

  Mitochondrial function will be assessed using an electrode sensitive to oxygen which measures the decrease in oxygen tension in the chamber after addition of substrates and modulators of mitochondrial oxidative phosphorylation. This will be assessed in placental tissue and the units is concentration of oxygen per mass per time.

  At delivery

Secondary Outcomes (1)

• Placental lipid metabolism

  At delivery

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rio de Janeiro State University: lead
• Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.: collaborator
• Rio de Janeiro State Research Supporting Foundation (FAPERJ): collaborator
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator
• University of Cambridge: collaborator
• Université Montpellier: collaborator
• Universidade Federal do Rio de Janeiro: collaborator
• Maternidade Escola da UFRJ: collaborator

Study Sites (1)

Maternidade Escola da UFRJ

Rio de Janeiro, Brazil

Location

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, serum, placental tissue

MeSH Terms

Conditions

Pregnancy Complications; Pregnancy in Obesity; Diabetes, Gestational

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Study Officials

• Tatiana El-Bacha, DSc

  UFRJ

  PRINCIPAL INVESTIGATOR

• Carolina S Ferreira, DSc

  UFRJ

  STUDY CHAIR

• Deborah AB Guimarães, DSc

  UFRJ

  STUDY CHAIR

• Gabriela DA Pinto, DSc

  UFRJ

  STUDY CHAIR

• Vanessa A Goes, DSc

  UFRJ

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 4, 2021
• First Posted: January 3, 2022
• Study Start: July 20, 2017
• Primary Completion: January 25, 2019
• Study Completion: December 1, 2024
• Last Updated: May 14, 2024

Record last verified: 2024-05

Locations

BR (1)