Pregnancy ComplicationsIMPACTINGNCT05174728
Innovations in Placental Metabolism and Association With Antioxidants and Nutrients in Diabetes and Gestational Obesity
An observational study of Pregnancy Complications and Obesity, Maternal, run by Rio de Janeiro State University at 1 site in Brazil.
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). Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Complications, Obesity, Maternal, Diabetes Mel Gestational - in Pregnancy
- How many people
- 120 participants
- Where
- 1 siteBrazil
- Study dates
- 20 Jul 2017to Dec 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
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Keywords
- pregnancy, gestational diabetes mellitus, pre-gestational maternal obesity
- Medical subject headings
- Pregnancy Complications, Pregnancy in Obesity, Diabetes, Gestational
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: At delivery
Secondary outcomes (1)
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.
Measured: At delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2022
- Study start20 Jul 2017
- Primary completion25 Jan 2019
- Study completionDec 2024 (estimated)
Why it stopped: COVID-19 Pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy ComplicationsStudies 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rio de Janeiro State University
- Sponsor type
- University, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Rio de Janeiro State Research Supporting Foundation (FAPERJ), Conselho Nacional de Desenvolvimento Científico e Tecnológico, University of Cambridge, Université Montpellier, Universidade Federal do Rio de Janeiro, Maternidade Escola da UFRJ
- Responsible party
- Principal investigator, Tatiana El Bacha Porto, Rio de Janeiro State University
- Investigators
- Tatiana El-Bacha, DSc, Principal investigator, UFRJCarolina S Ferreira, DSc, Study chair, UFRJDeborah AB Guimarães, DSc, Study chair, UFRJGabriela DA Pinto, DSc, Study chair, UFRJVanessa A Goes, DSc, Study chair, UFRJ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05174728
- Sponsor's protocol ID
- 66949217.0.0000.5275
- Acronym
- IMPACTING
- Status last verified
- May 2024
- First submitted
- 4 Nov 2021
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It might be available if there is enough funding to perform RNA sequencing and DNA methylation in placental samples. The data to be shared will involved differential expressed genes and methylation sites in the placenta in order to help the investigation of the placental role in the origins of chronic diseases.
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovations in Placental Metabolism and Association With Antioxidants and Nutrients in Diabetes and Gestational Obesity
- ClinicalTrials.gov ID
- NCT05174728
- Acronym / sponsor ID
- IMPACTING / 66949217.0.0000.5275
- Keywords
- pregnancy, gestational diabetes mellitus, pre-gestational maternal obesity
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: COVID-19 Pandemic
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Rio de Janeiro State UniversityUniversity, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Rio de Janeiro State Research Supporting Foundation (FAPERJ), Conselho Nacional de Desenvolvimento Científico e Tecnológico, University of Cambridge, Université Montpellier, Universidade Federal do Rio de Janeiro, Maternidade Escola da UFRJ
- Study start
- 20 Jul 2017 (actual)
- Primary completion
- 25 Jan 2019 (actual)
- Study completion
- Dec 2024 (estimated)
- First posted
- 3 Jan 2022 (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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Maternal redox homeostasis
Time frame: between 24th and 28th gestational week
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).
Maternal redox homeostasis [change]
Time frame: between 34th and 35th gestational week
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).
Fetal (cord blood) redox homeostasis
Time frame: At delivery
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).
Placental redox homeostasis
Time frame: At delivery
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).
Maternal inflammatory profile
Time frame: between 24th and 28th gestational week
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.
Maternal inflammatory profile [change]
Time frame: between 34th and 35th gestational week
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.
Fetal (cord blood) inflammatory profile
Time frame: At delivery
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.
Placental inflammatory profile
Time frame: At delivery
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.
Maternal metabolic profile
Time frame: between 24th and 28th gestational week
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
Maternal metabolic profile [change]
Time frame: between 34th and 35th gestational week
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
Fetal (cord blood) metabolic profile
Time frame: At delivery
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
Placental metabolic profile
Time frame: At delivery
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
Placental mitochondrial function at delivery
Time frame: 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.
1 secondary outcome
Placental lipid metabolism
Time frame: At delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
- Individual participant dataSharing planned: Undecided. It might be available if there is enough funding to perform RNA sequencing and DNA methylation in placental samples. The data to be shared will involved differential expressed genes and methylation sites in the placenta in order to help the investigation of the placental role in the origins of chronic diseases.
Related trials for Pregnancy Complications
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Population Pharmacokinetics of Temocillin in Acute Enterobacterial Pyelonephritis in Children
Pyelonephritis
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
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.
Tatiana El-Bacha, DSc principal investigator
UFRJ
Carolina S Ferreira, DSc study chair
UFRJ
Deborah AB Guimarães, DSc study chair
UFRJ
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 Pregnancy Complications and Obesity, Maternal, run by Rio de Janeiro State University at 1 site in Brazil.
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 5 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: paused, as of the sponsor's last update on 14 May 2024. 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 Brazil. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal redox homeostasis (time frame: between 24th and 28th gestational week). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 May 2024.