Actively Recruiting
Effects of Moderate Carbohydrate Consumption on Metabolic and Obstetric Outcomes in Pregnant Women With Insulin-treated Diabetes- A Randomized Controlled Trial
Led by Hadassah Medical Organization · Updated on 2025-10-02
120
Participants Needed
1
Research Sites
192 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effects of Moderate Carbohydrate Consumption on Metabolic and Obstetric Outcomes in Pregnant Women With Insulin-treated Diabetes- A Randomized Controlled Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant women with a single baby
- Age over 18 years and up to 45 years
- Diagnosed with gestational diabetes by 3-hour 100-g OGTT, or type 1 or 2 diabetes before pregnancy, or early gestational diabetes by OGTT or elevated fasting/postprandial glucose
- Already on or planning to start intensive insulin therapy (at least 2 injections per day) or using an insulin pump
- Willing to wear a continuous glucose monitoring system
- Body mass index between 18.5 and 42 kg/m2 at diagnosis
You will not qualify if you...
- Having risk factors for placental insufficiency
- Having high blood pressure
- Having kidney disease
- Having thrombophilia (blood clotting disorder)
- Having rheumatologic diseases
- History of preeclampsia or fetal growth restriction
- History of preterm labor
- Using beta-blockers or glucocorticoids
- Smoking or consuming any alcohol during pregnancy
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Hadassah Hospital
Jerusalem, Israel
Actively Recruiting
Research Team
G
Genya Aharon Hananel, DR MD PHD
CONTACT
N
naama shirazi, mrs
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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