Trial record 4 of 1134 for:    Open Studies | "Pregnancy"

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2008 by University Hospital, Lille.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by:
University Hospital, Lille
ClinicalTrials.gov Identifier:
NCT00639964
First received: March 14, 2008
Last updated: April 8, 2010
Last verified: March 2008
  Purpose

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.

Condition Intervention
Pregnancy
Pregnancy in Diabetes
Type 1 Diabetes Mellitus
Type 2 Diabetes Mellitus
Macrosomia
Other: blood tests
Other: diet questionnaire
Other: umbilical cord blood collect
Other: placenta collect

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Exploration of the Lipid Metabolism During the Diabetic Pregnancies and Research for New Biological Predictors to Nutritional Interventions

Resource links provided by NLM:


Further study details as provided by University Hospital, Lille:

Primary Outcome Measures:
  • fetal weight corrected by gestational age [ Time Frame: just after delivery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • cholesterol (total, HDL, LDL) [ Time Frame: 3 measures during pregnancy and 1 at post partum, 1 measure at time of delivery from fetal cord ] [ Designated as safety issue: No ]
  • triglycerides [ Time Frame: 3 measures during pregnancy and 1 at post partum, 1 measure at time of delivery from fetal cord ] [ Designated as safety issue: No ]
  • Apolipoprotein A/B rate [ Time Frame: 3 measures during pregnancy and 1 at post partum, 1 measure at time of delivery from fetal cord ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 210
Study Start Date: January 2008
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: type 1 diabetic pregnant women
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
No Intervention: type 2 diabetic pregnant women
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
No Intervention: 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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00639964

Contacts
Contact: Anne VAMBERGUE, MDPHD 0033320444513 a-vambergue@chru-lille.fr
Contact: Philippe DERUELLE, MD 0033320444160 p-deruelle@chru-lille.fr

Locations
France
CHRU, Lille Recruiting
Lille, France, 59037
Contact: Anne VAMBERGUE, MDPHD    0033320444513    a-vambergue@chru-lille.fr   
Contact: Philippe DERUELLE, MD    0033320444160    p-deruelle@chru-lille.fr   
Sponsors and Collaborators
University Hospital, Lille
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 Roubaix Hospital
Principal Investigator: Delphine VINCENT-DESPLANQUE, MD Roubaix Hospital
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
  More Information

No publications provided

Responsible Party: A VAMBERGUE, Principal Investigator, University Hospital, Lille
ClinicalTrials.gov Identifier: NCT00639964     History of Changes
Other Study ID Numbers: 2007-A00534-49, 2007/0714, PHRC 2007/R1901, DGS 2007-0340
Study First Received: March 14, 2008
Last Updated: April 8, 2010
Health Authority: France: Direction Générale de la Santé

Keywords provided by University Hospital, Lille:
diabetes
pregnancy
macrosomia
lipidics markers
nutritional factors
placenta
umbilical blood cord

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Pregnancy in Diabetics
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Pregnancy Complications

ClinicalTrials.gov processed this record on July 23, 2014