Skip to content

Determination of Maternal and Neonatal Apelinemia in Obese Women During Pregnancy

Determination of Maternal and Neonatal Apelinemia in Obese Women During Pregnancy

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02796456
Acronym
OB-APE
Enrollment
135
Registered
2016-06-10
Start date
2016-04-30
Completion date
2018-04-30
Last updated
2018-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gestational Diabetes, Obesity, Pregnancy

Keywords

apelin, colostrum, plasma, glycemic markers, lipidic markers, pregnancy, postpartum

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.

Interventions

OTHERblood sample

Sponsors

University Hospital, Lille
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 42 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Biological measure : Maternal apelinemia (Plasma Concentration)between 35 and 41 weeks of gestation (WG)plasma sample

Secondary

MeasureTime frameDescription
Biological measure : Maternal apelinemia (Plasma Concentration)the day of the delivery and 2 days after the deliveryplasma sample
apelin level in the colostrum2 days after the deliverycolostrum sample
C-peptidebetween 35 and 41 weeks of gestation (WG) and 2 days after the deliverymaternal plasma sample
glycemiabetween 35 and 41 weeks of gestation (WG) and 2 days after the deliverymaternal plasma sample
insulinemiabetween 35 and 41 weeks of gestation (WG) and 2 days after the deliverymaternal plasma sample
total cholesterolbetween 35 and 41 weeks of gestation (WG) and 2 days after the deliverymaternal plasma sample
HDLbetween 35 and 41 weeks of gestation (WG) and 2 days after the deliverymaternal plasma sample
LDLbetween 35 and 41 weeks of gestation (WG) and 2 days after the deliverymaternal plasma sample
Biological measure : Neonatal apelinemia (Plasma Concentration)the day of the deliveryplasma sample
apolipoprotein Abetween 35 and 41 weeks of gestation (WG) and 2 days after the deliverymaternal plasma sample
apolipoprotein Bbetween 35 and 41 weeks of gestation (WG) and 2 days after the deliverymaternal plasma sample
Biological measure : HDLthe day of the deliveryneonatal plasma sample
Biological measure : LDLthe day of the deliveryneonatal plasma sample
BMIat baselinemeasure maternal gain of weight before pregnancy and during pregnancy in maternal declaration
Infant weightwithin 2 days of postpartum
Infant sizewithin 5 days of postpartum
Placenta weightthe days of the delivery
triglyceridesbetween 35 and 41 weeks of gestation (WG) and 2 days after the deliverymaternal plasma sample

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026