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

Last updated: March 5, 2025
Sponsor: Eastern Virginia Medical School
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes And Hypertension

Diabetes Prevention

Treatment

Fiber

Clinical Study ID

NCT06867861
24-08-FB-0214
  • Ages 18-50
  • Female

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Singleton gestation

  • Known or new diagnosis of gestational diabetes without reason for medication

  • Age >=18 to <=50

Exclusion

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 FetalMedicine.

Study Design

Total Participants: 110
Treatment Group(s): 1
Primary Treatment: Fiber
Phase:
Study Start date:
February 24, 2025
Estimated Completion Date:
August 26, 2026

Study 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.

Connect with a study center

  • Macon & Joan Brock Virginia Health Sciences at ODU

    Norfolk, Virginia 23507
    United States

    Active - Recruiting

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