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Exploration of the Lipid Metabolism During the Diabetic Pregnancies

NCT ID: NCT00639964

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

186 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2013-12-31

Brief Summary

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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

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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.

Conditions

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Pregnancy Pregnancy in Diabetes Type 1 Diabetes Mellitus Type 2 Diabetes Mellitus

Keywords

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diabetes pregnancy macrosomia lipidics markers nutritional factors placenta umbilical blood cord

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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type 1 diabetic pregnant women

type 1 diabetic pregnant women

Group Type OTHER

blood tests

Intervention Type OTHER

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

diet questionnaire

Intervention Type OTHER

questions about nutrition before and during pregnancy

umbilical cord blood collect

Intervention Type OTHER

collected at the delivery

placenta collect

Intervention Type OTHER

collected at the delivery

type 2 diabetic pregnant women

type 2 diabetic pregnant women

Group Type OTHER

blood tests

Intervention Type OTHER

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

diet questionnaire

Intervention Type OTHER

questions about nutrition before and during pregnancy

umbilical cord blood collect

Intervention Type OTHER

collected at the delivery

placenta collect

Intervention Type OTHER

collected at the delivery

healthy pregnant women

healthy pregnant women with normal glucose tolerance

Group Type OTHER

blood tests

Intervention Type OTHER

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

diet questionnaire

Intervention Type OTHER

questions about nutrition before and during pregnancy

umbilical cord blood collect

Intervention Type OTHER

collected at the delivery

placenta collect

Intervention Type OTHER

collected at the delivery

Interventions

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blood tests

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

Intervention Type OTHER

diet questionnaire

questions about nutrition before and during pregnancy

Intervention Type OTHER

umbilical cord blood collect

collected at the delivery

Intervention Type OTHER

placenta collect

collected at the delivery

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ministry of Health, France

OTHER_GOV

Sponsor Role collaborator

University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Salha FENDRI, MD

Role: PRINCIPAL_INVESTIGATOR

Amiens University Hospital

Anne VAMBERGUE, MDPHD

Role: STUDY_DIRECTOR

University Hospital, Lille

Isabelle FAJARDY, PharmD

Role: PRINCIPAL_INVESTIGATOR

Univesity Hospital, Lille

Annie MARTIN, PharmD PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Gilbert BRIAND, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Jean ROUSSEAUX, MDPhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Damien SUBTIL, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Philippe DUFOUR, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Pierre FONTAINE, MDPHD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Philippe DERUELLE, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Françoise LE GOUEFF, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier de Roubaix

Delphine VINCENT-DESPLANQUE, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier de Roubaix

Lucie BRESSON, MD

Role: PRINCIPAL_INVESTIGATOR

Lille University Hospital

Eleonore DELARUE, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Lille

Odile GAGNEUR, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Lille

Locations

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CHRU, Lille

Lille, , France

Site Status

Countries

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France

References

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Bouvier D, Rouzaire M, Marceau G, Prat C, Pereira B, Lemarie R, Deruelle P, Fajardy I, Gallot D, Blanchon L, Vambergue A, Sapin V. Aquaporins and Fetal Membranes From Diabetic Parturient Women: Expression Abnormalities and Regulation by Insulin. J Clin Endocrinol Metab. 2015 Oct;100(10):E1270-9. doi: 10.1210/jc.2015-2057. Epub 2015 Jul 24.

Reference Type RESULT
PMID: 26207951 (View on PubMed)

Other Identifiers

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2007/0714

Identifier Type: -

Identifier Source: org_study_id

2007-A00534-49

Identifier Type: OTHER

Identifier Source: secondary_id

PHRC 2007/R1901

Identifier Type: OTHER

Identifier Source: secondary_id

DGS 2007-0340

Identifier Type: OTHER

Identifier Source: secondary_id