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

University Hospital, Lille

Status: Completed

Conditions: Gestational Diabetes; Obesity; Pregnancy

Treatments: Other: blood sample

Study type: Observational

Funder types: Other

Identifiers

NCT02796456

2014_70

2015-A01696-43 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 135 patients

Sex: Female

Ages: 18 to 42 years old

Volunteers: No Healthy Volunteers

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

Trial design

135 participants in 3 patient groups

Normal weight women

Description:

BMI between 18.5 and 25 kg/m2 and without gestational diabetes

Treatment:

Other: blood sample

Obese women without gestational diabetes

Description:

BMI more than 30 kg/m2 and without gestational diabetes

Treatment:

Other: blood sample

Obese women with gestational diabetes

Description:

BMI more than 30 kg/m2 and with gestational diabetes

Treatment:

Other: blood sample