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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

Tracking Information
First Submitted Date May 19, 2016
First Posted Date June 10, 2016
Last Update Posted Date June 13, 2018
Study Start Date April 2016
Actual Primary Completion Date April 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 9, 2016)
Biological measure : Maternal apelinemia (Plasma Concentration) [ Time Frame: between 35 and 41 weeks of gestation (WG) ]
plasma sample
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 9, 2016)
  • Biological measure : Neonatal apelinemia (Plasma Concentration) [ Time Frame: the day of the delivery ]
    plasma sample
  • Biological measure : Maternal apelinemia (Plasma Concentration) [ Time Frame: the day of the delivery and 2 days after the delivery ]
    plasma sample
  • apelin level in the colostrum [ Time Frame: 2 days after the delivery ]
    colostrum sample
  • C-peptide [ Time Frame: between 35 and 41 weeks of gestation (WG) and 2 days after the delivery ]
    maternal plasma sample
  • glycemia [ Time Frame: between 35 and 41 weeks of gestation (WG) and 2 days after the delivery ]
    maternal plasma sample
  • insulinemia [ Time Frame: between 35 and 41 weeks of gestation (WG) and 2 days after the delivery ]
    maternal plasma sample
  • C-peptide [ Time Frame: the day of the delivery ]
    neonatal plasma sample
  • glycemia [ Time Frame: the day of the delivery ]
    neonatal plasma sample
  • insulinemia [ Time Frame: the day of the delivery ]
    neonatal plasma sample
  • total cholesterol [ Time Frame: between 35 and 41 weeks of gestation (WG) and 2 days after the delivery ]
    maternal plasma sample
  • HDL [ Time Frame: between 35 and 41 weeks of gestation (WG) and 2 days after the delivery ]
    maternal plasma sample
  • LDL [ Time Frame: between 35 and 41 weeks of gestation (WG) and 2 days after the delivery ]
    maternal plasma sample
  • triglycerides [ Time Frame: between 35 and 41 weeks of gestation (WG) and 2 days after the delivery ]
    maternal plasma sample
  • apolipoprotein A [ Time Frame: between 35 and 41 weeks of gestation (WG) and 2 days after the delivery ]
    maternal plasma sample
  • apolipoprotein B [ Time Frame: between 35 and 41 weeks of gestation (WG) and 2 days after the delivery ]
    maternal plasma sample
  • total cholesterol [ Time Frame: the day of the delivery ]
    neonatal plasma sample
  • Biological measure : HDL [ Time Frame: the day of the delivery ]
    neonatal plasma sample
  • Biological measure : LDL [ Time Frame: the day of the delivery ]
    neonatal plasma sample
  • triglycerides [ Time Frame: the day of the delivery ]
    neonatal plasma sample
  • apolipoprotein A [ Time Frame: the day of the delivery ]
    neonatal plasma sample
  • apolipoprotein B [ Time Frame: the day of the delivery ]
    neonatal plasma sample
  • BMI [ Time Frame: at baseline ]
    measure maternal gain of weight before pregnancy and during pregnancy in maternal declaration
  • Infant weight [ Time Frame: within 2 days of postpartum ]
  • Infant size [ Time Frame: within 5 days of postpartum ]
  • Placenta weight [ Time Frame: the days of the delivery ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Determination of Maternal and Neonatal Apelinemia in Obese Women During Pregnancy
Official Title Determination of Maternal and Neonatal Apelinemia in Obese Women During Pregnancy
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.

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.

Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Placenta samples will be collected and RT-qPCR will be done to analyze RNA in each group.
Sampling Method Probability Sample
Study Population Women between 18 and 42 years old, pregnant, between 35 and 40 WG.
Condition
  • Obesity
  • Pregnancy
  • Gestational Diabetes
Intervention Other: blood sample
Study Groups/Cohorts
  • Normal weight women
    BMI between 18.5 and 25 kg/m2 and without gestational diabetes
    Intervention: Other: blood sample
  • Obese women without gestational diabetes
    BMI more than 30 kg/m2 and without gestational diabetes
    Intervention: Other: blood sample
  • Obese women with gestational diabetes
    BMI more than 30 kg/m2 and with gestational diabetes
    Intervention: Other: blood sample
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 12, 2018)
135
Original Estimated Enrollment
 (submitted: June 9, 2016)
120
Actual Study Completion Date April 2018
Actual Primary Completion Date April 2018   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 42 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT02796456
Other Study ID Numbers 2014_70
2015-A01696-43 ( Other Identifier: ID-RCB number, ANSM )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party University Hospital, Lille
Study Sponsor University Hospital, Lille
Collaborators Not Provided
Investigators
Principal Investigator: Philippe Deruelle, MD, PhD University Hospital, Lille
PRS Account University Hospital, Lille
Verification Date June 2018