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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02796456
Other study ID # 2014_70
Secondary ID 2015-A01696-43
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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