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Completed

NCT Number: NCT00639964

Exploration of the Lipid Metabolism During the Diabetic Pregnancies

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.

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Key information

Conditions

Pregnancy Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy Complications Pregnancy in Diabetes Pregnancy in Diabetics Type 1 Diabetes Mellitus Type 2 Diabetes Mellitus Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CHRU, Lille

Lille, 59037, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood tests

Other

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

diet questionnaire

Other

questions about nutrition before and during pregnancy

umbilical cord blood collect

Other

collected at the delivery

placenta collect

Other

collected at the delivery

Primary outcomes

  1. fetal weight corrected by gestational age

    Time frame: just after delivery

Secondary outcomes

  1. cholesterol (total, HDL, LDL)

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

  2. triglycerides

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

  3. Apolipoprotein A/B rate

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

  4. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Collaborators

  • Ministry of Health, France

Registry information

Official study title

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

Acronym: DIAMANT

Important dates

Study start
2008
Primary completion
2012
Study completion
2013
First posted
Mar 20, 2008
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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