Determination of Maternal and Neonatal Apelinemia in Obese Women During Pregnancy

Obesity Clinical Trial

— OB-APE  

Official title:

Determination of Maternal and Neonatal Apelinemia in Obese Women During Pregnancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02796456
• Other study ID #: 2014_70
• Secondary ID: 2015-A01696-43
• Status: Completed
• Start date: April 2016
• Est. completion date: April 2018

Study information

• Verified date: June 2018
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: April 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 42 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes, Gestational
• Gestational Diabetes
• Obesity
• Pregnancy

Intervention

Other:
• blood sample

Locations

Country	Name	City	State
France	Hôpital Jeanne de Flandre - CHRU de Lille	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biological measure : Maternal apelinemia (Plasma Concentration)	plasma sample	between 35 and 41 weeks of gestation (WG)
Secondary	Biological measure : Neonatal apelinemia (Plasma Concentration)	plasma sample	the day of the delivery
Secondary	Biological measure : Maternal apelinemia (Plasma Concentration)	plasma sample	the day of the delivery and 2 days after the delivery
Secondary	apelin level in the colostrum	colostrum sample	2 days after the delivery
Secondary	C-peptide	maternal plasma sample	between 35 and 41 weeks of gestation (WG) and 2 days after the delivery
Secondary	glycemia	maternal plasma sample	between 35 and 41 weeks of gestation (WG) and 2 days after the delivery
Secondary	insulinemia	maternal plasma sample	between 35 and 41 weeks of gestation (WG) and 2 days after the delivery
Secondary	C-peptide	neonatal plasma sample	the day of the delivery
Secondary	glycemia	neonatal plasma sample	the day of the delivery
Secondary	insulinemia	neonatal plasma sample	the day of the delivery
Secondary	total cholesterol	maternal plasma sample	between 35 and 41 weeks of gestation (WG) and 2 days after the delivery
Secondary	HDL	maternal plasma sample	between 35 and 41 weeks of gestation (WG) and 2 days after the delivery
Secondary	LDL	maternal plasma sample	between 35 and 41 weeks of gestation (WG) and 2 days after the delivery
Secondary	triglycerides	maternal plasma sample	between 35 and 41 weeks of gestation (WG) and 2 days after the delivery
Secondary	apolipoprotein A	maternal plasma sample	between 35 and 41 weeks of gestation (WG) and 2 days after the delivery
Secondary	apolipoprotein B	maternal plasma sample	between 35 and 41 weeks of gestation (WG) and 2 days after the delivery
Secondary	total cholesterol	neonatal plasma sample	the day of the delivery
Secondary	Biological measure : HDL	neonatal plasma sample	the day of the delivery
Secondary	Biological measure : LDL	neonatal plasma sample	the day of the delivery
Secondary	triglycerides	neonatal plasma sample	the day of the delivery
Secondary	apolipoprotein A	neonatal plasma sample	the day of the delivery
Secondary	apolipoprotein B	neonatal plasma sample	the day of the delivery
Secondary	BMI	measure maternal gain of weight before pregnancy and during pregnancy in maternal declaration	at baseline
Secondary	Infant weight		within 2 days of postpartum
Secondary	Infant size		within 5 days of postpartum
Secondary	Placenta weight		the days of the delivery