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

Pregnancy Complications Clinical Trial

— IMPACTING  

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT05174728
• Other study ID #: 66949217.0.0000.5275
• Status: Suspended
• Start date: July 20, 2017
• Est. completion date: December 2023

Study information

• Verified date: October 2022
• Source: Rio de Janeiro State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 120
• Est. completion date: December 2023
• Est. primary completion date: January 25, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Obesity
• Pregnancy Complications

Locations

Country	Name	City	State
Brazil	Maternidade Escola da UFRJ	Rio de Janeiro

Sponsors (8)

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

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Placental lipid metabolism	To investigate the alterations in lipid metabolism as a function of pre-gestational maternal obesity and gestational diabetes mellitus. Lipid metabolism will be assessed by lipid analysis using mass spectrometry to identify the major categories and lipid species in maternal, fetal and placental tissue. The unit is relative abundance per mass of tissue and volume of plasma.	At delivery