Exploration of the Lipid Metabolism During the Diabetic Pregnancies

Type 2 Diabetes Mellitus Clinical Trial

— DIAMANT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00639964
• Other study ID #: 2007/0714
• Secondary ID: 2007-A00534-49PH
• Status: Completed
• Phase: N/A
• First received: March 14, 2008
• Last updated: May 31, 2016
• Start date: January 2008
• Est. completion date: December 2013

Study information

• Verified date: May 2016
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Direction Générale de la Santé
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 186
• Est. completion date: December 2013
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type 2
• Pregnancy
• Pregnancy in Diabetes
• Pregnancy in Diabetics
• Type 1 Diabetes Mellitus
• Type 2 Diabetes Mellitus

Intervention

Other:
• blood tests
3 measures during pregnancy and 1 at post partum, 1 measure at time of delivery from fetal cord
• diet questionnaire
questions about nutrition before and during pregnancy
• umbilical cord blood collect
collected at the delivery
• placenta collect
collected at the delivery

Locations

Country	Name	City	State
France	CHRU, Lille	Lille

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Lille	Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fetal weight corrected by gestational age		just after delivery	No
Secondary	cholesterol (total, HDL, LDL)		3 measures during pregnancy and 1 at post partum, 1 measure at time of delivery from fetal cord	No
Secondary	triglycerides		3 measures during pregnancy and 1 at post partum, 1 measure at time of delivery from fetal cord	No
Secondary	Apolipoprotein A/B rate		3 measures during pregnancy and 1 at post partum, 1 measure at time of delivery from fetal cord	No
Secondary	erythrocytary and plasmatic fatty acid distribution		3 measures during pregnancy and 1 at post partum, 1 measure at time of delivery from fetal cord	No