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RECRUITING
NCT06355154
NA

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

View on ClinicalTrials.gov

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

Interventions

OTHER

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