Exploration of the Lipid Metabolism During the Diabetic Pregnancies (DIAMANT)
Recruitment status was Recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- fetal weight corrected by gestational age [ Time Frame: just after delivery ] [ Designated as safety issue: No ]
- 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 |
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| Contact: Anne VAMBERGUE, MDPHD | 0033320444513 | a-vambergue@chru-lille.fr |
| Contact: Philippe DERUELLE, MD | 0033320444160 | p-deruelle@chru-lille.fr |
| 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 | |
| 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 May 19, 2013