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Exploration of the Lipid Metabolism During the Diabetic Pregnancies

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00639964
Acronym
DIAMANT
Enrollment
186
Registered
2008-03-20
Start date
2008-01-31
Completion date
2013-12-31
Last updated
2025-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

OTHERblood tests

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

OTHERdiet questionnaire

questions about nutrition before and during pregnancy

OTHERumbilical cord blood collect

collected at the delivery

OTHERplacenta collect

collected at the delivery

Sponsors

Ministry of Health, France
CollaboratorOTHER_GOV
University Hospital, Lille
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
fetal weight corrected by gestational agejust after delivery

Secondary

MeasureTime frame
cholesterol (total, HDL, LDL)3 measures during pregnancy and 1 at post partum, 1 measure at time of delivery from fetal cord
triglycerides3 measures during pregnancy and 1 at post partum, 1 measure at time of delivery from fetal cord
Apolipoprotein A/B rate3 measures during pregnancy and 1 at post partum, 1 measure at time of delivery from fetal cord
erythrocytary and plasmatic fatty acid distribution3 measures during pregnancy and 1 at post partum, 1 measure at time of delivery from fetal cord

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026