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.
• Pregnant women with singleton pregnancies.
Over 18 years old.
Diagnosis of GDM- 3-h 100-g OGTT according to the American College of Obstetricians and Gynecologists supported by the American Diabetes Association, Or Diagnosis of type 1 or 2 diabetes before pregnancy, Or Diagnosis of early GDM by either OGTT in the first trimester or elevated blood glucose measurements in the fasting (above 95mg/dl) or the postprandial (above 140 mg/dl) state.
Are already on or intended to start intensive insulin treatment (at leased 2 injections of insulin per day) or wear an insulin pump.
Placental insufficiency.
Hypertension.
Renal disease.
Thrombophilia
Parallel
Nutritional intervention
Other interventionThe intervention will contain a diet with a reduced amount of carbohydrates compared to the standard treatment today but without caloric restriction.
Time in range
Percentage of time during the day that the patient is in the normal range of glucose balance in pregnancy
Time above range
Percentage of time during the day that the patient is above the normal range of glucose balance in pregnancy
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