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Completed

NCT Number: NCT02796456

Determination of Maternal and Neonatal Apelinemia in Obese Women During Pregnancy

Background :

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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Key information

About this study

Background :

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Obese pregnant women
  • Age from 18 to 42 years old
  • Singleton pregnancy between 35+0 to 41+6 weeks of pregnancy

Exclusion criteria

  • Severe heart, liver or kidney disease
  • 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

Treatment and study plan

blood sample

Other

Primary outcomes

  1. Biological measure : Maternal apelinemia (Plasma Concentration)

    Time frame: between 35 and 41 weeks of gestation (WG)

    plasma sample

Secondary outcomes

  1. Biological measure : Neonatal apelinemia (Plasma Concentration)

    Time frame: the day of the delivery

    plasma sample

  2. Biological measure : Maternal apelinemia (Plasma Concentration)

    Time frame: the day of the delivery and 2 days after the delivery

    plasma sample

  3. apelin level in the colostrum

    Time frame: 2 days after the delivery

    colostrum sample

  4. C-peptide

    Time frame: between 35 and 41 weeks of gestation (WG) and 2 days after the delivery

    maternal plasma sample

  5. glycemia

    Time frame: between 35 and 41 weeks of gestation (WG) and 2 days after the delivery

    maternal plasma sample

  6. insulinemia

    Time frame: between 35 and 41 weeks of gestation (WG) and 2 days after the delivery

    maternal plasma sample

  7. C-peptide

    Time frame: the day of the delivery

    neonatal plasma sample

  8. glycemia

    Time frame: the day of the delivery

    neonatal plasma sample

  9. insulinemia

    Time frame: the day of the delivery

    neonatal plasma sample

  10. total cholesterol

    Time frame: between 35 and 41 weeks of gestation (WG) and 2 days after the delivery

    maternal plasma sample

  11. HDL

    Time frame: between 35 and 41 weeks of gestation (WG) and 2 days after the delivery

    maternal plasma sample

  12. LDL

    Time frame: between 35 and 41 weeks of gestation (WG) and 2 days after the delivery

    maternal plasma sample

  13. triglycerides

    Time frame: between 35 and 41 weeks of gestation (WG) and 2 days after the delivery

    maternal plasma sample

  14. apolipoprotein A

    Time frame: between 35 and 41 weeks of gestation (WG) and 2 days after the delivery

    maternal plasma sample

  15. apolipoprotein B

    Time frame: between 35 and 41 weeks of gestation (WG) and 2 days after the delivery

    maternal plasma sample

  16. total cholesterol

    Time frame: the day of the delivery

    neonatal plasma sample

  17. Biological measure : HDL

    Time frame: the day of the delivery

    neonatal plasma sample

  18. Biological measure : LDL

    Time frame: the day of the delivery

    neonatal plasma sample

  19. triglycerides

    Time frame: the day of the delivery

    neonatal plasma sample

  20. apolipoprotein A

    Time frame: the day of the delivery

    neonatal plasma sample

  21. apolipoprotein B

    Time frame: the day of the delivery

    neonatal plasma sample

  22. BMI

    Time frame: at baseline

    measure maternal gain of weight before pregnancy and during pregnancy in maternal declaration

  23. Infant weight

    Time frame: within 2 days of postpartum

  24. Infant size

    Time frame: within 5 days of postpartum

  25. Placenta weight

    Time frame: the days of the delivery

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Acronym: OB-APE

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jun 10, 2016
Registry last updated
Jun 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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