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Effects of Moderate Carbohydrate Consumption on Metabolic and Obstetric Outcomes in Pregnant Women With Insulin-treated Diabetes- A Randomized Controlled Trial
Sponsor: Hadassah Medical Organization
Summary
Diabetes during pregnancy increases maternal and fetal complications, necessitating optimal glycemic control. The standard care diet (SCD, ≥175g/day carbohydrate) lacks robust evidence, particularly for pregnancies requiring intensive insulin treatment (IIT). This RCT investigates whether a moderate carbohydrate diet (MCD, ≤120g/day) versus SCD improves glycemic control and alters metabolomic profiles in pregnant individuals on IIT. Aims: To compare the efficacy and safety of a SCD versus MCD on glycemic control, metabolomic signatures, and pregnancy outcomes in pregnant individuals on IIT.
Key Details
Gender
FEMALE
Age Range
18 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2024-05-28
Completion Date
2028-02-01
Last Updated
2025-10-02
Healthy Volunteers
No
Conditions
Interventions
Nutritional intervention
The intervention will contain a diet with a reduced amount of carbohydrates compared to the standard treatment today but without caloric restriction.
Locations (1)
Hadassah Hospital
Jerusalem, Israel