Clinical trial NCT00639964: Exploration of the Lipid Metabolism During the Diabetic Pregnancies
Official title: Exploration of the Lipid Metabolism During the Diabetic Pregnancies and Research for New Biological Predictors to Nutritional Interventions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Pregnancy in Diabetes
Type 1 Diabetes Mellitus
Type 2 Diabetes Mellitus
Keywords: diabetes
pregnancy
macrosomia
lipidics markers
nutritional factors
placenta
umbilical blood cord
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2008-03-20
Enrollment: 186
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief 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.

Detailed description: Plan of study:

Longitudinal study on 3 groups: 70 type 1 diabetic women, 70 type 2 diabetic women and 70 women with normal glucose tolerance during pregnancy. Recruitment in the department of Diabetology and Obstetrics of CHRU of Amiens and Lille.

Nutritional survey and sampling of blood in the 1st, 2nd and 3rd trimester of pregnancy and at 6 weeks post partum.

Collection of cord blood and placental tissues. Histological and molecular analysis of placenta will be realized both in the departments of Anatomopathology of Lille and Amiens and in Biochemistry Molecular Biology of CHRU of Lille.

Homocysteine and folate assays on cord blood will be centralized in Paris (Hospital St Louis).

Main criteria of judgment

Fetal weight corrected by the gestational age.

Expected results:

* An inverse correlation between maternal and fetal blood fatty acids ratios (polyunsaturated fatty acids/ monounsaturated fatty acids + saturated) and birth weight in the diabetic groups.
* Differences of distribution of fatty acids of maternal and foetal erythrocytic phospholipids correlated with the fetal weight.
* Qualitative and quantitative variations of expression of placental genes such as lipases and genes submitted to parental imprinting.

The biologic parameters will be confronted with the data of the nutritional survey and with glycemic control during pregnancy.

Eligibility criteria: Inclusion Criteria:

* pregnant women included before 16 amenorrhea weeks

Exclusion Criteria:

* obesity (BMI \> 40kg/m2)
* subject became pregnant with medical infertility treatment
* tobacco \> 10
* suspected abuse of alcohol

Primary outcomes:
measure: fetal weight corrected by gestational age
timeFrame: just after delivery
Secondary outcomes:
measure: cholesterol (total, HDL, LDL)
timeFrame: 3 measures during pregnancy and 1 at post partum, 1 measure at time of delivery from fetal cord
measure: triglycerides
timeFrame: 3 measures during pregnancy and 1 at post partum, 1 measure at time of delivery from fetal cord
measure: Apolipoprotein A/B rate
timeFrame: 3 measures during pregnancy and 1 at post partum, 1 measure at time of delivery from fetal cord
measure: erythrocytary and plasmatic fatty acid distribution
timeFrame: 3 measures during pregnancy and 1 at post partum, 1 measure at time of delivery from fetal cord
Other outcomes:
Locations:
city: Lille
country: France
facility: CHRU, Lille
Study officials:
affiliation: University Hospital, Lille
name: Anne VAMBERGUE, MDPHD
role: STUDY_DIRECTOR
affiliation: Univesity Hospital, Lille
name: Isabelle FAJARDY, PharmD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Lille
name: Annie MARTIN, PharmD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Lille
name: Gilbert BRIAND, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Lille
name: Jean ROUSSEAUX, MDPhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Lille
name: Damien SUBTIL, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Lille
name: Philippe DUFOUR, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Lille
name: Pierre FONTAINE, MDPHD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Lille
name: Philippe DERUELLE, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Amiens University Hospital
name: Salha FENDRI, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Hospitalier de Roubaix
name: Françoise LE GOUEFF, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Hospitalier de Roubaix
name: Delphine VINCENT-DESPLANQUE, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lille University Hospital
name: Lucie BRESSON, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital of Lille
name: Eleonore DELARUE, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital of Lille
name: Odile GAGNEUR, MD
role: PRINCIPAL_INVESTIGATOR
References: