Determination of Maternal and Neonatal Apelinemia in Obese Women During Pregnancy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Determination of Maternal and Neonatal Apelinemia in Obese Women During Pregnancy

Conditions
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Obesity, Pregnancy, Gestational Diabetes

Intervention / Treatment
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* Other: blood sample


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 42 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Normal weight women<br>BMI between 18.5 and 25 kg/m2 and without gestational diabetes | Other: blood sample<br> <br> |
| Obese women without gestational diabetes<br>BMI more than 30 kg/m2 and without gestational diabetes | Other: blood sample<br> <br> |
| Obese women with gestational diabetes<br>BMI more than 30 kg/m2 and with gestational diabetes | Other: blood sample<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biological measure : Maternal apelinemia (Plasma Concentration) | plasma sample | between 35 and 41 weeks of gestation (WG) | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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apelin, colostrum, plasma, glycemic markers, lipidic markers, pregnancy, postpartum