Exploration of the Lipid Metabolism During the Diabetic Pregnancies
DIAMANT
4 other identifiers
interventional
186
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable pregnancy
Started Jan 2008
Longer than P75 for not_applicable pregnancy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2008
CompletedFirst Submitted
Initial submission to the registry
March 14, 2008
CompletedFirst Posted
Study publicly available on registry
March 20, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedDecember 22, 2025
May 1, 2016
4 years
March 14, 2008
December 15, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
fetal weight corrected by gestational age
just after delivery
Secondary Outcomes (4)
cholesterol (total, HDL, LDL)
3 measures during pregnancy and 1 at post partum, 1 measure at time of delivery from fetal cord
triglycerides
3 measures during pregnancy and 1 at post partum, 1 measure at time of delivery from fetal cord
Apolipoprotein A/B rate
3 measures during pregnancy and 1 at post partum, 1 measure at time of delivery from fetal cord
erythrocytary and plasmatic fatty acid distribution
3 measures during pregnancy and 1 at post partum, 1 measure at time of delivery from fetal cord
Study Arms (3)
type 1 diabetic pregnant women
OTHERtype 1 diabetic pregnant women
type 2 diabetic pregnant women
OTHERtype 2 diabetic pregnant women
healthy pregnant women
OTHERhealthy pregnant women with normal glucose tolerance
Interventions
3 measures during pregnancy and 1 at post partum, 1 measure at time of delivery from fetal cord
questions about nutrition before and during pregnancy
collected at the delivery
collected at the delivery
Eligibility Criteria
You may qualify if:
- pregnant women included before 16 amenorrhea weeks
You may not qualify if:
- obesity (BMI \> 40kg/m2)
- subject became pregnant with medical infertility treatment
- tobacco \> 10
- suspected abuse of alcohol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Lillelead
- Ministry of Health, Francecollaborator
Study Sites (1)
CHRU, Lille
Lille, 59037, France
Related Publications (1)
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.
PMID: 26207951RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
University Hospital, Lille
- PRINCIPAL INVESTIGATOR
Eleonore DELARUE, MD
University Hospital of Lille
- PRINCIPAL INVESTIGATOR
Odile GAGNEUR, MD
University Hospital of Lille
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 14, 2008
First Posted
March 20, 2008
Study Start
January 1, 2008
Primary Completion
January 1, 2012
Study Completion
December 1, 2013
Last Updated
December 22, 2025
Record last verified: 2016-05