Moderate carbohydrate diet effects on pregnant women with diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the impact of a moderate carbohydrate diet (≤120g/day) compared to the standard care diet (≥175g/day) on glycemic control and metabolic outcomes in pregnant women with insulin-treated diabetes. The study aims to determine if the moderate carbohydrate approach can improve glycemic balance and alter metabolomic profiles, potentially leading to better pregnancy outcomes. Participants will be monitored using continuous glucose monitoring systems to assess their metabolic responses throughout the trial.

Why it matters

Who can join: the full rules

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.

Where it's running

• Hadassah Hospital
  Jerusalem, Israel Recruiting

Study contacts

• Study coordinator: Genya Aharon Hananel, DR MD PHD
• Email: Genyah@hadassah.org.il
• Phone: 0525576455

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.