Determination of Maternal and Neonatal Apelinemia in Obese Women During Pregnancy

NCT02796456 | Completed

• 2 other identifiers: 2014_702015-A01696-43
• Study Type: observational
• Target: 135
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Pregnancy; Gestational Diabetes

Keywords

apelin; colostrum; plasma; glycemic markers; lipidic markers; pregnancy; postpartum

Outcome Measures

Primary Outcomes (1)

• Biological measure : Maternal apelinemia (Plasma Concentration)

  plasma sample

  between 35 and 41 weeks of gestation (WG)

Secondary Outcomes (25)

• Biological measure : Neonatal apelinemia (Plasma Concentration)

  the day of the delivery

• Biological measure : Maternal apelinemia (Plasma Concentration)

  the day of the delivery and 2 days after the delivery

• apelin level in the colostrum

  2 days after the delivery

• C-peptide

  between 35 and 41 weeks of gestation (WG) and 2 days after the delivery

• glycemia

  between 35 and 41 weeks of gestation (WG) and 2 days after the delivery

Study Arms (3)

Normal weight women

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

Other: blood sample

Obese women without gestational diabetes

BMI more than 30 kg/m2 and without gestational diabetes

Other: blood sample

Obese women with gestational diabetes

BMI more than 30 kg/m2 and with gestational diabetes

Other: blood sample

Interventions

blood sample OTHER

Normal weight women; Obese women with gestational diabetes; Obese women without gestational diabetes

Eligibility Criteria

• Age: 18 Years - 42 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Women between 18 and 42 years old, pregnant, between 35 and 40 WG.

You may qualify if:

• Obese pregnant women
• Age from 18 to 42 years old
• Singleton pregnancy between 35+0 to 41+6 weeks of pregnancy

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

Hôpital Jeanne de Flandre - CHRU de Lille

Lille, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

Placenta samples will be collected and RT-qPCR will be done to analyze RNA in each group.

MeSH Terms

Conditions

Obesity; Diabetes, Gestational

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Philippe Deruelle, MD, PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2016
• First Posted: June 10, 2016
• Study Start: April 1, 2016
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: June 13, 2018

Record last verified: 2018-06

Locations

FR (1)