Effects of Moderate Carbohydrate Consumption on Metabolic and Obstetric Outcomes in Pregnant Women With Insulin-treated Diabetes- A Randomized Controlled Trial

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.

Eligibility

Inclusion Criteria:

* • 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.
  * Are willing to wear a continuous glucose monitoring system.
  * BMI of 18.5-42 kg/m2 at the time of diagnosis.

Exclusion Criteria:

* Individual with risk factors for:

  * Placental insufficiency.
  * Hypertension.
  * Renal disease.
  * Thrombophilia
  * Rheumatologic disease.
  * A history of preeclampsia, or fetal growth restriction (IUGR).
  * Individuals with a history of preterm labor, or concomitant therapy with β-blockers or glucocorticoids.
  * Individuals who smoke and/or consume any amount of alcohol during pregnancy.

Conditions2

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