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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-A00534-49 | Other Identifier | ID-RCB number, ANSM | |
| PHRC 2007/R1901 | Other Identifier | DHOS | |
| DGS 2007-0340 | Other Identifier | AFSSAPS |
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| Name | Class |
|---|---|
| Ministry of Health, France | OTHER_GOV |
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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:
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:
The biologic parameters will be confronted with the data of the nutritional survey and with glycemic control during pregnancy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| type 1 diabetic pregnant women | Other | type 1 diabetic pregnant women |
|
| type 2 diabetic pregnant women | Other | type 2 diabetic pregnant women |
|
| healthy pregnant women | Other | healthy pregnant women with normal glucose tolerance |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| blood tests | Other | 3 measures during pregnancy and 1 at post partum, 1 measure at time of delivery from fetal cord |
|
| Measure | Description | Time Frame |
|---|---|---|
| fetal weight corrected by gestational age | just after delivery |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anne VAMBERGUE, MDPHD | University Hospital, Lille | Study Director |
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHRU, Lille | Lille | 59037 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26207951 | Result | 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. |
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| ID | Term |
|---|---|
| D011254 | Pregnancy in Diabetics |
| D003922 | Diabetes Mellitus, Type 1 |
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D044882 | Glucose Metabolism Disorders |
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| ID | Term |
|---|---|
| D006403 | Hematologic Tests |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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| 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 |
|
| 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 |
| 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 | Principal Investigator |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |