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Effect of Fiber Supplementation on the Need for Medication With Gestational Diabetes

Effect of Fiber Supplementation on the Need for Medication With Gestational Diabetes

Recruiting
18-50 years
Female
Phase N/A

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Overview

The hypotheses to be tested are 1) Fiber supplementation will decrease the need for medication in patients with gestational diabetes, and 2) Fiber supplementation will decrease adverse maternal and neonatal outcomes in these patients. In this study, the investigators will conduct a randomized controlled trial to limit bias in evaluating these hypotheses.

Description

The study team proposes a randomized controlled trial of women with singleton pregnancies who present with a new diagnosis of diet-controlled gestational diabetes (previously referred to as GDMA1). The participants will be randomized to the intervention group (fiber supplementation) or control group (no fiber supplementation) in 1:1 fashion. The participant will be randomized by a number-generating computer software after recruitment at the new gestational diabetes education class.

Eligibility

Inclusion Criteria:

  • Singleton gestation
  • Known or new diagnosis of gestational diabetes without reason for medication
  • Age >=18 to <=50

Exclusion Criteria:

-

  • Non-English as primary language.
    • Known or suspected fetal anomaly or aneuploidy.
    • Known lower bowel disorder
    • Known phenylketonuria
    • Prisoners.
    • Management of diabetes outside of Eastern Virginia Medical School Maternal Fetal Medicine.

Study details
    Gestational Diabetes Mellitus (GDM)

NCT06867861

Eastern Virginia Medical School

6 September 2025

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