Determination of Maternal and Neonatal Apelinemia in Obese Women During Pregnancy
NCT ID: NCT02796456
Last Updated: 2018-06-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
135 participants
OBSERVATIONAL
2016-04-30
2018-04-30
Brief Summary
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Apelin and its receptor APJ have been implicated in pathologies including cardiovascular disease, diabetes and obesity. Little is known about the function of the apelinergic system during gestation.
Objective :
The main objective of this study is to compare apelinemia in fasting normal weight and obese women at the end of pregnancy, between 35 and 41 weeks of gestation (WG).
Strategy and method:
A prospective research evaluating will be conducted to compare apelinemia in fasting normal weight and obese women at the end of pregnancy, between 35 and 41 weeks of gestation (WG).
A third group will be created to check if gestational diabetes is not a confounding factor in obesity (group of obese women with gestational diabetes).
Investigators will try to see if apelinemia is correlated to lipidic and glycemic markers.
Samples will be collected in the cord blood to compare maternal and neonatal apelinemia and to see if neonatal apelinemia is correlated to the child's weight and birth size and to the weight of the placenta.
Placenta samples will be collected and RT-qPCR will be done to analyze RNA in each group.
Two days after delivery, obese and not obese women will be fasted and plasma and colostrum will be collected. Investigators will compare apelin levels in the colostrum between these 2 groups and then investigators will try to see if apelin level is correlated in the colostrum and in maternal plasma.
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Detailed Description
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Apelin and its receptor APJ have been implicated in pathologies including cardiovascular disease, diabetes and obesity.
Little is known about the function of the apelinergic system during gestation.
In a previous study, investigators evaluated in mice this system at the feto-maternal interface in insulin-resistant obese female (HF) mice. Maternal apelinemia was decreased at term and fetal apelinemia was sixfold higher than maternal level. Ex-vivo, the placenta releases high amount of apelin at E12.5 and E18.5. In HF pregnant mice at term, apelinemia as well as placental apelin and APJ mRNA levels were increased whereas placental release of apelin was drastically reduced.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Normal weight women
BMI between 18.5 and 25 kg/m2 and without gestational diabetes
blood sample
Obese women without gestational diabetes
BMI more than 30 kg/m2 and without gestational diabetes
blood sample
Obese women with gestational diabetes
BMI more than 30 kg/m2 and with gestational diabetes
blood sample
Interventions
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blood sample
Eligibility Criteria
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Inclusion Criteria
* Age from 18 to 42 years old
* Singleton pregnancy between 35+0 to 41+6 weeks of pregnancy
Exclusion Criteria
* Multiple pregnancy
* Hypertension, preeclampsia, small for gestational age
* Pre-gestational diabetes
* Bariatric surgery
* Medication other than normal pregnancy supplementations
* Tabacco or drugs consummation during pregnancy
* Provided artificial feeding
* Fetal anoxia with cord pH less than 7.0
* Genetic or chromosomal mother's and / or newborn's abnormality
* Fetal malformation
* Trusteeship or tutorship
* Refusal to participate in research
* Unable to attend the entire study
18 Years
42 Years
FEMALE
No
Sponsors
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University Hospital, Lille
OTHER
Responsible Party
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Principal Investigators
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Philippe Deruelle, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Lille
Locations
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Hôpital Jeanne de Flandre - CHRU de Lille
Lille, , France
Countries
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Other Identifiers
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2015-A01696-43
Identifier Type: OTHER
Identifier Source: secondary_id
2014_70
Identifier Type: -
Identifier Source: org_study_id
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