PregnancyDIAMANTNCT00639964
Exploration of the Lipid Metabolism During the Diabetic Pregnancies
A study testing blood tests, diet questionnaire and umbilical cord blood collect in people with Pregnancy and Pregnancy in Diabetes, run by University Hospital, Lille at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Pregnancy in Diabetes, Type 1 Diabetes Mellitus
- What is being tested?
- blood tests, diet questionnaire and umbilical cord blood collect
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2008to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- pregnant women included before 16 amenorrhea weeks
Who cannot join
- obesity (BMI > 40kg/m2)
- subject became pregnant with medical infertility treatment
- tobacco > 10
- suspected abuse of alcohol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploration of the Lipid Metabolism During the Diabetic Pregnancies and Research for New Biological Predictors to Nutritional Interventions
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.
Read more
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.
Read the 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.
- Being tested
- blood tests, diet questionnaire, umbilical cord blood collect, placenta collect
- Keywords
- diabetes, pregnancy, macrosomia, lipidics markers, nutritional factors, placenta, umbilical blood cord
- Medical subject headings
- Pregnancy in Diabetics, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood testsOther
3 measures during pregnancy and 1 at post partum, 1 measure at time of delivery from fetal cord
diet questionnaireOther
questions about nutrition before and during pregnancy
umbilical cord blood collectOther
collected at the delivery
placenta collectOther
collected at the delivery
| Study group | Role | What they receive |
|---|---|---|
| type 1 diabetic pregnant women | Other | type 1 diabetic pregnant women Receives: Other: blood tests; Other: diet questionnaire; Other: umbilical cord blood collect; Other: placenta collect |
| type 2 diabetic pregnant women | Other | type 2 diabetic pregnant women Receives: Other: blood tests; Other: diet questionnaire; Other: umbilical cord blood collect; Other: placenta collect |
| healthy pregnant women | Other | healthy pregnant women with normal glucose tolerance Receives: Other: blood tests; Other: diet questionnaire; Other: umbilical cord blood collect; Other: placenta collect |
What is being measured
The primary outcome is the main question the study is designed to answer.
fetal weight corrected by gestational age
Measured: just after delivery
Secondary outcomes (4)
cholesterol (total, HDL, LDL)
Measured: 3 measures during pregnancy and 1 at post partum, 1 measure at time of delivery from fetal cord
triglycerides
Measured: 3 measures during pregnancy and 1 at post partum, 1 measure at time of delivery from fetal cord
Apolipoprotein A/B rate
Measured: 3 measures during pregnancy and 1 at post partum, 1 measure at time of delivery from fetal cord
erythrocytary and plasmatic fatty acid distribution
Measured: 3 measures during pregnancy and 1 at post partum, 1 measure at time of delivery from fetal cord
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2008 (estimated)
- Study startJan 2008
- Primary completionJan 2012
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Anne VAMBERGUE, MDPHD, Study director, University Hospital, LilleIsabelle FAJARDY, PharmD, Principal investigator, Univesity Hospital, LilleAnnie MARTIN, PharmD PhD, Principal investigator, University Hospital, LilleGilbert BRIAND, PhD, Principal investigator, University Hospital, LilleJean ROUSSEAUX, MDPhD, Principal investigator, University Hospital, LilleDamien SUBTIL, MD, Principal investigator, University Hospital, LillePhilippe DUFOUR, MD, Principal investigator, University Hospital, LillePierre FONTAINE, MDPHD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00639964
- Sponsor's protocol ID
- 2007/0714
- Other IDs
- 2007-A00534-49, PHRC 2007/R1901, DGS 2007-0340
- Acronym
- DIAMANT
- Status last verified
- May 2016
- First submitted
- 14 Mar 2008
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 26207951
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration of the Lipid Metabolism During the Diabetic Pregnancies and Research for New Biological Predictors to Nutritional Interventions
- ClinicalTrials.gov ID
- NCT00639964
- Acronym / sponsor ID
- DIAMANT / 2007/0714
- Keywords
- diabetes, pregnancy, macrosomia, lipidics markers, nutritional factors, placenta, umbilical blood cord
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- Jan 2008
- Primary completion
- Jan 2012 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 20 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| type 1 diabetic pregnant women | Other | Other: blood tests, Other: diet questionnaire, Other: umbilical cord blood collect, Other: placenta collecttype 1 diabetic pregnant women |
| type 2 diabetic pregnant women | Other | Other: blood tests, Other: diet questionnaire, Other: umbilical cord blood collect, Other: placenta collecttype 2 diabetic pregnant women |
| healthy pregnant women | Other | Other: blood tests, Other: diet questionnaire, Other: umbilical cord blood collect, Other: placenta collecthealthy pregnant women with normal glucose tolerance |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- pregnant women included before 16 amenorrhea weeks
Key exclusion criteria (4 listed)
- obesity (BMI > 40kg/m2)
- subject became pregnant with medical infertility treatment
- tobacco > 10
- suspected abuse of alcohol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood tests3 measures during pregnancy and 1 at post partum, 1 measure at time of delivery from fetal cord | Other | healthy pregnant women, type 1 diabetic pregnant women, type 2 diabetic pregnant women |
| diet questionnairequestions about nutrition before and during pregnancy | Other | healthy pregnant women, type 1 diabetic pregnant women, type 2 diabetic pregnant women |
| umbilical cord blood collectcollected at the delivery | Other | healthy pregnant women, type 1 diabetic pregnant women, type 2 diabetic pregnant women |
| placenta collectcollected at the delivery | Other | healthy pregnant women, type 1 diabetic pregnant women, type 2 diabetic pregnant women |
Primary outcome
fetal weight corrected by gestational age
Time frame: just after delivery
4 secondary outcomes
cholesterol (total, HDL, LDL)
Time frame: 3 measures during pregnancy and 1 at post partum, 1 measure at time of delivery from fetal cord
triglycerides
Time frame: 3 measures during pregnancy and 1 at post partum, 1 measure at time of delivery from fetal cord
Apolipoprotein A/B rate
Time frame: 3 measures during pregnancy and 1 at post partum, 1 measure at time of delivery from fetal cord
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Results publication: PubMed 26207951Bouvier 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne VAMBERGUE, MDPHD study director
University Hospital, Lille
Isabelle FAJARDY, PharmD principal investigator
Univesity Hospital, Lille
Annie MARTIN, PharmD PhD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood tests, diet questionnaire and umbilical cord blood collect in people with Pregnancy and Pregnancy in Diabetes, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fetal weight corrected by gestational age (time frame: just after delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00639964, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.