Choline Supplementation on Fetal Growth in Gestational Diabetes Mellitus
Gestational diabetes mellitus (GDM), characterized by maternal high blood sugar, affects up to 15% of pregnancies worldwide. GDM doubles the risk of fetal growth (i.e. macrosomia, large fetus,) which further predisposes the affected fetus to elevated risks of obesity, diabetes and cardiovascular disease later in life. The placenta mediates macrosomia by increasing fat and glucose transport to the fetus during GDM. Effective methods to normalize placental nutrient transport and prevent macrosomia are lacking. Choline is a semi-essential nutrient found in egg yolks, meat, fish and cruciferous vegetables. The demand for this nutrient increases substantially during pregnancy. Previous research demonstrated that maternal choline supplementation (MCS) normalized placental fat and glucose transport as well as fetal growth and fat mass in GDM mice. In this study, the investigators will recruit pregnant women with GDM and randomized them to receive a choline supplement (470mg/day, a dose with demonstrated safety), or a placebo for 8 weeks, starting after gestational week 28. The investigators will determine the effects of choline on fetal growth as well as the influence of choline on placental transport and epigenetic modifications in growth-related genes in the placenta and umbilical cord. Successful completion of this study will provide valuable insights into the use of choline supplement as a modifier of placental macronutrient homeostasis in GDM to improve fetal growth outcomes.
Conditions:
🦠 Gestational Diabetes
🗓️ Study Start (Actual) 1 April 2020
🗓️ Primary Completion (Estimated) 30 June 2024
✅ Study Completion (Estimated) 31 December 2024
👥 Enrollment (Estimated) 60
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Brooklyn, New York, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * GDM pregnant women before gestational week 28.
    • * English or Spanish speaking, over 18 years of age
    • * singleton pregnancy
    • * intending to deliver their babies at Maimonides Medical Center

    Exclusion Criteria:

    • * pre-existing hyperglycemia
    • * diabetes
    • * cardiovascular conditions and liver disease prior to pregnancy.
Ages Eligible for Study: 18 Years to 50 Years (ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 6 March 2020
  • First Submitted that Met QC Criteria 6 March 2020
  • First Posted 10 March 2020

Study Record Updates

  • Last Update Submitted that Met QC Criteria 21 October 2023
  • Last Update Posted 24 October 2023
  • Last Verified October 2023