Exploration of the Lipid Metabolism During the Diabetic Pregnancies

NCT00639964 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 186

Last updated 2025-12-22

No results posted yet for this study

Summary

Justification:

Intrauterine exposure to type 1 or type 2 diabetes increase the risk of macrosomia (35 % to 50 % versus 10 % in general population) despite a good glycemic control. The consequences are : shoulder's dystocia, lung immaturity, caesarean section, neonatal hypoglycaemia and a high frequency of obesity and metabolic disorders in adults.

The mechanisms of macrosomia are unclear; chronic hyperglycemia and subsequent hyperinsulinaemia observed during the diabetic pregnancy might explain only partially the fetal weight. Considerable interest has been generated over the last decade on the lipids and fatty acids alterations in diabetes pregnancies. Change in lipoproteins metabolism have been described associated with macrosomia. Maternal nutrition before and during pregnancy plays an important role in fetal growth and subsequent development of an increased susceptibility to obesity and diabetes in later life.

Main objective:

Looking for an association between maternal and fetal blood lipid parameters and birth weight and body fat in a context of type 1 or type 2 diabetes.

Secondary objectives:

* Identify lipid markers associated with fetal macrosomia.
* Analyze the placenta by measuring the expression of genes implicated in the storage and the transfer of fatty acids.
* Analyze and compare the expression level of placental genes subjected to parental imprinting and validated in animal models.

Conditions

Interventions

OTHER

blood tests

3 measures during pregnancy and 1 at post partum, 1 measure at time of delivery from fetal cord

OTHER

diet questionnaire

questions about nutrition before and during pregnancy

OTHER

umbilical cord blood collect

collected at the delivery

OTHER

placenta collect

collected at the delivery

Sponsors & Collaborators

  • Ministry of Health, France

    collaborator OTHER_GOV
  • University Hospital, Lille

    lead OTHER

Principal Investigators

  • Anne VAMBERGUE, MDPHD · University Hospital, Lille

  • Isabelle FAJARDY, PharmD · Univesity Hospital, Lille

  • Annie MARTIN, PharmD PhD · University Hospital, Lille

  • Gilbert BRIAND, PhD · University Hospital, Lille

  • Jean ROUSSEAUX, MDPhD · University Hospital, Lille

  • Damien SUBTIL, MD · University Hospital, Lille

  • Philippe DUFOUR, MD · University Hospital, Lille

  • Pierre FONTAINE, MDPHD · University Hospital, Lille

  • Philippe DERUELLE, MD · University Hospital, Lille

  • Salha FENDRI, MD · Amiens University Hospital

  • Françoise LE GOUEFF, MD · Centre Hospitalier de Roubaix

  • Delphine VINCENT-DESPLANQUE, MD · Centre Hospitalier de Roubaix

  • Lucie BRESSON, MD · Lille University Hospital

  • Eleonore DELARUE, MD · University Hospital of Lille

  • Odile GAGNEUR, MD · University Hospital of Lille

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2012-01-31
Completion
2013-12-31

Countries

  • France

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00639964 on ClinicalTrials.gov