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Determination of Maternal and Neonatal Apelinemia in Obese Women During Pregnancy (OB-APE)

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ClinicalTrials.gov Identifier: NCT02796456
Recruitment Status : Completed
First Posted : June 10, 2016
Last Update Posted : June 13, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille

Brief Summary:

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.


Condition or disease Intervention/treatment
Obesity Pregnancy Gestational Diabetes Other: blood sample

Detailed Description:

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.


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Study Type : Observational
Actual Enrollment : 135 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Determination of Maternal and Neonatal Apelinemia in Obese Women During Pregnancy
Study Start Date : April 2016
Actual Primary Completion Date : April 2018
Actual Study Completion Date : April 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Normal weight women
BMI between 18.5 and 25 kg/m2 and without gestational diabetes
Other: blood sample
Obese women without gestational diabetes
BMI more than 30 kg/m2 and without gestational diabetes
Other: blood sample
Obese women with gestational diabetes
BMI more than 30 kg/m2 and with gestational diabetes
Other: blood sample



Primary Outcome Measures :
  1. Biological measure : Maternal apelinemia (Plasma Concentration) [ Time Frame: between 35 and 41 weeks of gestation (WG) ]
    plasma sample


Secondary Outcome Measures :
  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 ]

Biospecimen Retention:   Samples With DNA
Placenta samples will be collected and RT-qPCR will be done to analyze RNA in each group.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 42 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Women between 18 and 42 years old, pregnant, between 35 and 40 WG.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02796456


Locations
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France
Hôpital Jeanne de Flandre - CHRU de Lille
Lille, France
Sponsors and Collaborators
University Hospital, Lille
Investigators
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Principal Investigator: Philippe Deruelle, MD, PhD University Hospital, Lille

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Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT02796456     History of Changes
Other Study ID Numbers: 2014_70
2015-A01696-43 ( Other Identifier: ID-RCB number, ANSM )
First Posted: June 10, 2016    Key Record Dates
Last Update Posted: June 13, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Lille:
apelin
colostrum
plasma
glycemic markers
lipidic markers
pregnancy
postpartum

Additional relevant MeSH terms:
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Diabetes, Gestational
Pregnancy Complications
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases