Exploration of the Lipid Metabolism During the Diabetic Pregnancies (DIAMANT)

December 15, 2025 updated by: University Hospital, Lille

Exploration of the Lipid Metabolism During the Diabetic Pregnancies and Research for New Biological Predictors to Nutritional Interventions

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

186

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lille, France, 59037
        • CHRU, Lille

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: type 1 diabetic pregnant women
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
Other: type 2 diabetic pregnant women
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
Other: healthy pregnant women
healthy pregnant women with normal glucose tolerance
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
fetal weight corrected by gestational age
Time Frame: just after delivery
just after delivery

Secondary Outcome Measures

Outcome Measure
Time Frame
cholesterol (total, HDL, LDL)
Time Frame: 3 measures during pregnancy and 1 at post partum, 1 measure at time of delivery from fetal cord
3 measures during pregnancy and 1 at post partum, 1 measure at time of delivery from fetal cord
triglycerides
Time Frame: 3 measures during pregnancy and 1 at post partum, 1 measure at time of delivery from fetal cord
3 measures during pregnancy and 1 at post partum, 1 measure at time of delivery from fetal cord
Apolipoprotein A/B rate
Time Frame: 3 measures during pregnancy and 1 at post partum, 1 measure at time of delivery from fetal cord
3 measures during pregnancy and 1 at post partum, 1 measure at time of delivery from fetal cord
erythrocytary and plasmatic fatty acid distribution
Time Frame: 3 measures during pregnancy and 1 at post partum, 1 measure at time of delivery from fetal cord
3 measures during pregnancy and 1 at post partum, 1 measure at time of delivery from fetal cord

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Collaborators

Ministry of Health, France

Investigators

  • Study Director: Anne VAMBERGUE, MDPHD, University Hospital, Lille
  • Principal Investigator: Isabelle FAJARDY, PharmD, Univesity Hospital, Lille
  • Principal Investigator: Annie MARTIN, PharmD PhD, University Hospital, Lille
  • Principal Investigator: Gilbert BRIAND, PhD, University Hospital, Lille
  • Principal Investigator: Jean ROUSSEAUX, MDPhD, University Hospital, Lille
  • Principal Investigator: Damien SUBTIL, MD, University Hospital, Lille
  • Principal Investigator: Philippe DUFOUR, MD, University Hospital, Lille
  • Principal Investigator: Pierre FONTAINE, MDPHD, University Hospital, Lille
  • Principal Investigator: Philippe DERUELLE, MD, University Hospital, Lille
  • Principal Investigator: Salha FENDRI, MD, Amiens university hospital
  • Principal Investigator: Françoise LE GOUEFF, MD, Centre Hospitalier de Roubaix
  • Principal Investigator: Delphine VINCENT-DESPLANQUE, MD, Centre Hospitalier de Roubaix
  • Principal Investigator: Lucie BRESSON, MD, Lille University Hospital
  • Principal Investigator: Eleonore DELARUE, MD, University Hospital of Lille
  • Principal Investigator: Odile GAGNEUR, MD, University Hospital of Lille

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

March 14, 2008

First Submitted That Met QC Criteria

March 19, 2008

First Posted (Estimated)

March 20, 2008

Study Record Updates

Last Update Posted (Estimated)

December 22, 2025

Last Update Submitted That Met QC Criteria

December 15, 2025

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007/0714
  • 2007-A00534-49 (Other Identifier: ID-RCB number, ANSM)
  • PHRC 2007/R1901 (Other Identifier: DHOS)
  • DGS 2007-0340 (Other Identifier: AFSSAPS)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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