Clinical trial NCT02796456: Determination of Maternal and Neonatal Apelinemia in Obese Women During Pregnancy
Official title: Determination of Maternal and Neonatal Apelinemia in Obese Women During Pregnancy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Pregnancy
Gestational Diabetes
Keywords: apelin
colostrum
plasma
glycemic markers
lipidic markers
pregnancy
postpartum
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2016-06-10
Enrollment: 135
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women between 18 and 42 years old, pregnant, between 35 and 40 WG.

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.

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

Primary outcomes:
measure: Biological measure : Maternal apelinemia (Plasma Concentration)
timeFrame: between 35 and 41 weeks of gestation (WG)
Secondary outcomes:
measure: Biological measure : Neonatal apelinemia (Plasma Concentration)
timeFrame: the day of the delivery
measure: Biological measure : Maternal apelinemia (Plasma Concentration)
timeFrame: the day of the delivery and 2 days after the delivery
measure: apelin level in the colostrum
timeFrame: 2 days after the delivery
measure: C-peptide
timeFrame: between 35 and 41 weeks of gestation (WG) and 2 days after the delivery
measure: glycemia
timeFrame: between 35 and 41 weeks of gestation (WG) and 2 days after the delivery
measure: insulinemia
timeFrame: between 35 and 41 weeks of gestation (WG) and 2 days after the delivery
measure: C-peptide
timeFrame: the day of the delivery
measure: glycemia
timeFrame: the day of the delivery
measure: insulinemia
timeFrame: the day of the delivery
measure: total cholesterol
timeFrame: between 35 and 41 weeks of gestation (WG) and 2 days after the delivery
measure: HDL
timeFrame: between 35 and 41 weeks of gestation (WG) and 2 days after the delivery
measure: LDL
timeFrame: between 35 and 41 weeks of gestation (WG) and 2 days after the delivery
measure: triglycerides
timeFrame: between 35 and 41 weeks of gestation (WG) and 2 days after the delivery
measure: apolipoprotein A
timeFrame: between 35 and 41 weeks of gestation (WG) and 2 days after the delivery
measure: apolipoprotein B
timeFrame: between 35 and 41 weeks of gestation (WG) and 2 days after the delivery
measure: total cholesterol
timeFrame: the day of the delivery
measure: Biological measure : HDL
timeFrame: the day of the delivery
measure: Biological measure : LDL
timeFrame: the day of the delivery
measure: triglycerides
timeFrame: the day of the delivery
measure: apolipoprotein A
timeFrame: the day of the delivery
measure: apolipoprotein B
timeFrame: the day of the delivery
measure: BMI
timeFrame: at baseline
measure: Infant weight
timeFrame: within 2 days of postpartum
measure: Infant size
timeFrame: within 5 days of postpartum
measure: Placenta weight
timeFrame: the days of the delivery
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital Jeanne de Flandre - CHRU de Lille
Study officials:
affiliation: University Hospital, Lille
name: Philippe Deruelle, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: