Status:
ACTIVE_NOT_RECRUITING
Myo-inositol for Reduction of Insulin Therapy in Gestational Diabetes Mellitus
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Gestational Diabetes Mellitus
Eligibility:
All Genders
18-45 years
Phase:
NA
Brief Summary
Gestational diabetes mellitus (GDM) is defined as hyperglycemia first-diagnosed during pregnancy. Glycemic control reduces GDM-related complications. With the new diagnostic criteria of GDM, up to 25%...
Detailed Description
Prospective, multicenter, superiority, randomised, double blind study with two arms. 1. In the 23 participating centers selection of women with GDM between 6 to 37 (+6 days) amenorrhea weeks 2. Expla...
Eligibility Criteria
Inclusion
- Age ≥18 years
- Singleton pregnancy
- GDM diagnosed during pregnancy according to IADPSG (International Association of the Diabetes and Pregnancy Study Groups) criteria, i.e.
- fasting plasma glucose between 92 mg/dL (5.1 mmol/L) and 125 mg/dL (6.9 mmol/L)
- and/or 1-hour plasma glucose value after 75 g oral glucose tolerance test (OGTT) ≥ 180 mg/dL (10.0 mmol/L)
- and/or 2-hour plasma glucose value between 153 mg/dL (8.5 mmol/L) and 199 mg/dL ((11.0 mmol/L)
- or overt diabetes according to 2-hours post OGTT plasma glucose value ≥ 200 mg/dl
- 6 to 37 (+6 days) amenorrhea weeks at the time of randomization
- Capacity for self-monitoring of blood glucose
- Signed informed consent
Exclusion
- Insulin use before randomization during this pregnancy
- Use of other oral hypoglycemic agents during this pregnancy
- Long time corticosteroid treatment
- Pre-existing diabetes before pregnancy
- Overt diabetes diagnosed during pregnancy according to fasting plasma glucose ≥ 126 mg/dL (7 mmol/l)
- Lack of Social Insurance
- Insufficient French understanding and speaking
- Participant in another investigational drug study at inclusion visit
- Fetal malformation diagnosed by previous fetal ultrasound
- Personal history of any bariatric surgery
- Hypersensitivity to any ingredient of dietary supplement formulation
Key Trial Info
Start Date :
March 4 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 20 2027
Estimated Enrollment :
1080 Patients enrolled
Trial Details
Trial ID
NCT03875755
Start Date
March 4 2020
End Date
January 20 2027
Last Update
December 29 2025
Active Locations (2)
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1
Hôpital Avicenne
Bobigny, France, 93000
2
Hopital Avicenne
Bobigny, France