Moderate carbohydrate diet effects on pregnant women with diabetes
Effects of Moderate Carbohydrate Consumption on Metabolic and Obstetric Outcomes in Pregnant Women With Insulin-treated Diabetes- A Randomized Controlled Trial
This study tests if a moderate carbohydrate diet can help pregnant women with diabetes manage their blood sugar better than the standard diet.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Hadassah Medical Organization Academic / other |
| Locations | 1 site (Jerusalem) |
| Trial ID | NCT06355154 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include pregnant women over 18 years old with singleton pregnancies who are on intensive insulin treatment for diabetes.
Not a fit: Patients with risk factors for placental insufficiency, hypertension, renal disease, or a history of preeclampsia may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved glycemic control and reduced complications for pregnant women with diabetes.
How similar studies have performed: While some studies have explored carbohydrate restriction during pregnancy, this specific approach is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Jerusalem
- Hadassah Hospital — Jerusalem, Israel (Recruiting)
Study contacts
- Study coordinator: Genya Aharon Hananel, DR MD PHD
- Email: Genyah@hadassah.org.il
- Phone: 0525576455
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.