Status:
COMPLETED
Abnormal Post-partum Glucose Metabolism After Gestational Diabetes Diagnosed Before or After 24 Weeks of Gestation
Lead Sponsor:
Centre Hospitalier Universitaire de Nīmes
Conditions:
Gestational Diabetes
Type 2 Diabetes
Eligibility:
FEMALE
18+ years
Brief Summary
The main objective of the study is to estimate and compare the percentage of patients with abnormal glucose metabolism at 4-12 weeks postpartum between two groups: patients diagnosed with gestational ...
Detailed Description
The secondary objectives of this study are to compare between the two groups: A. the rate of type 2 diabetes only, glucose intolerance only, impaired fasting glucose only, and patients requiring insu...
Eligibility Criteria
Inclusion
- The patient must have given her informed and signed consent
- The patient must be insured or beneficiary of a health insurance plan
- The patient is available for 10 months of follow-up
- The patient is pregnant and consulting before 24 weeks of amenorrhea AND has at least one of the following risk factors: age \> 35 years; body mass index \> 25; family history of type 2 diabetes; history of gestational diabetes; history of macrosomia.
- The patient has a fasting blood glucose level \>= 0.92 g/l before 24 weeks of amenorrhea OR a fasting blood glucose level \< 0.92 g/l before 24 weeks of amenorrhea AND an abnormal oral glucose tolerance test (75 g of glucose) between 24 and 28 weeks of amenorrhea (normal values are set at T0 \< 0.92 g/l; T60 \< 1.80 g/l; T120 \< 1.53 g/l).
Exclusion
- The patient is participating in another study
- The patient is in an exclusion period determined by a previous study, with the exception of the following studies: Papillo PMA (RCB 2013-A00538-37), LXRs (RCB 2009-A00968-49), GrossPath (RCB 2014-A01120-47), BAKRI (RCB 2013-A00914-41), OASIS II (RCB 2013-A00773-42), ElastoMAP (RCB 2013-A01148-37), ElastoDéclench (RCB 2014-A00828-39) and UpSideDown (RCB 2014-A01921-46).
- The patient is under judicial protection, under tutorship or curatorship
- The patient refuses to sign the consent
- It is impossible to correctly inform the patient
- The patient cannot read French
- The patient has a known history of type 2 diabetes
- The patient is diagnosed with type 2 diabetes during pregnancy (fasting blood glucose level \> 1.26 g/l)
- The patient has a contra-indication for a treatment necessary for this study
- The patient is taking chronic or intermittent oral or inhaled corticosteroids, or a β2 agonist treatment for a previous disease or a disease discovered during pregnancy within one week preceding the fasting glucose or oral glucose tolerance test.
Key Trial Info
Start Date :
March 27 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 12 2016
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT01839448
Start Date
March 27 2014
End Date
October 12 2016
Last Update
November 19 2025
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
CH d'Arles - Hôpital Joseph Imbert
Arles, France, 13637
2
CHU de Montpellier - Hôpital Arnaud de Villeneuve
Montpellier, France, 34295
3
CHU de Montpellier - Hôpital Lapeyronie
Montpellier, France, 34295
4
CHU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, France, 30029