Status:
UNKNOWN
Carbohydrate Restriction in Pregnant Women With Gestation Diabetes Mellitus
Lead Sponsor:
Tel-Aviv Sourasky Medical Center
Conditions:
Gestational Diabetes
Eligibility:
FEMALE
18-45 years
Phase:
NA
Brief Summary
The purpose of this controlled, randomized intervention is to investigate whether a carbohydrate-restricted diet, having a positive effect on blood sugar and weigh maintaining in diabetes, is effectiv...
Detailed Description
Increasing prevalence of obesity and tendency to become pregnant later in life can explain rising prevalence of gestation diabetes (GDM) (1). Diabetes in pregnancy is a major public health issue: it h...
Eligibility Criteria
Inclusion
- Ages 18-45 years
- GDM diagnosed between 12 and 34 weeks gestation according to Carpenter and Coustan criteria (13)
- BMI 20-35 kg/m2
- Singleton pregnancy
- Willing to perform self-monitoring of blood glucose at least 4 times a day
- Self-monitoring of blood glucose
- 12 to 34 weeks of gestation at the time of randomization
- Signed informed consent
Exclusion
- Pre-existing diabetes in pregnancy, including first trimester fasting glucose ≥105 mg/dL
- Use of other oral hypoglycemic agents during this pregnancy
- Multiple pregnancy
- Known hepatic insufficiency (bilirubin \>50 µmol/L and/or protrombin time \<50 %)
- Insufficient understanding
- Participant in another investigational drug study at inclusion visits
- Fetal malformation diagnosed by previous fetal ultrasound
Key Trial Info
Start Date :
August 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 15 2021
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT04051359
Start Date
August 15 2019
End Date
August 15 2021
Last Update
August 9 2019
Active Locations (1)
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1
Department of Endocrinology, Metabolism and Hypertension, Tel-Aviv Sourasky Medical Center
Tel Aviv, Israel, 64239