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

RecruitingNAAges 18 Years - 45 YearsFemaleHadassah Medical Organization
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In plain words

What the trial is, and whether it could suit you

Diabetes during pregnancy increases maternal and fetal complications, necessitating optimal glycemic control. The standard care diet (SCD, โ‰ฅ175g/day carbohydrate) lacks robust evidence, particularly for pregnancies requiring intensive insulin treatment (IIT). This RCT investigates whether a moderate carbohydrate diet (MCD, โ‰ค120g/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.

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * โ€ข 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 ฮฒ-blockers or glucocorticoids. * Individuals who smoke and/or consume any amount of alcohol during pregnancy.
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What it tests

  • Nutritional intervention
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Where

1 site
Hadassah Hospital
Jerusalem, Israel
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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