Last updated: January 26, 2023
Sponsor: University Hospital, Lille
Overall Status: Active - Recruiting
Phase
N/A
Condition
Diabetes Prevention
Diabetes (Pediatric)
Pregnancy Complications
Treatment
N/AClinical Study ID
NCT04451915
2017_76
2018-A00794-51
PHRC-17-008
Ages > 18 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Pregnant woman
- Singleton pregnancy
- Early GDM defined by a fasting plasma glucose between 5.1 mmol/l and 6.1 mmol/ with atleast one risk factor (age ≥35 years and/or BMI ≥ 25 kg/m2 and/or familial history ofdiabetes and/or personal history of GDM and/or personal history of macrosomia).
- First prenatal visit prior 20 weeks of gestation at the time of randomization.
- Signed informed consent
Exclusion
Exclusion Criteria: Diabetic follow-up started at time of inclusion
- Pre-existing diabetes in pregnancy
- Renal impairment
- Hepatic insufficiency
- History of bariatric surgery
- Long time corticosteroids treatment
- Insufficient understanding
- Language difficulties
- Lack of social Insurance
- Person in emergency situation
- Person under the protection of justice (tutelage/ curatorship)
- Persons deprived of their liberty
Study Design
Total Participants: 2010
Study Start date:
November 30, 2020
Estimated Completion Date:
December 31, 2023
Connect with a study center
CH ARRAS
Arras,
FranceActive - Recruiting
Hopital Estaing - Chu63 - Clermont Ferrand
Clermont-Ferrand,
FranceActive - Recruiting
Hop Claude Huriez Chu Lille
Lille, 59037
FranceActive - Recruiting
Hopital Saint Vincent - Saint Antoine - Lille
Lille, 59037
FranceActive - Recruiting
Chu Nimes Caremeau - Nimes 9
Nîmes,
FranceActive - Recruiting
Hopital Haut-Leveque - Chu - Pessac
Pessac, 33604
FranceActive - Recruiting
Ch Rene Dubos - Pontoise
Pontoise,
FranceActive - Recruiting
Chu Site Sud (Saint Pierre) - St Pierre
Saint-Pierre,
FranceActive - Recruiting
Csapa / Hus / Hopital Civil - Strasbourg
Strasbourg, 67091
FranceActive - Recruiting
Hopital de Rangueil Chu Toulouse
Toulouse, 31300
FranceActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.