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Fiber Supplementation for Gestational Diabetes

This study is looking at whether taking a psyllium fiber supplement can reduce the need for medication in women with gestational diabetes (diabetes that develops during pregnancy). Researchers want to see if 16 grams of psyllium fiber per day, taken as capsules throughout pregnancy, can help manage blood sugar levels. You might be able to join if you are a woman between 18 and 50 years old, have a single pregnancy, and have a new diagnosis of gestational diabetes that doesn't yet require medication. The main goal is to see how many participants need medication for their gestational diabetes up to 7 months after starting the study. The current recruitment status is unclear.

Study design
This is an interventional study that will randomly assign 110 participants to either receive the fiber supplement or no fiber supplement. This helps to limit bias in evaluating the study's hypotheses.
What's involved
You would be instructed to take 4 psyllium fiber capsules twice daily for a total of 16g of soluble fiber per day, continuing throughout your pregnancy.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed from the date of randomization until the date of first documented progression, assessed up to 7 months.

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NCT06867861

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

Recruiting
NAAges 18–50InterventionalPrevention
Eastern Virginia Medical School
~110 participants
Updated 2025-03-10 on ClinicalTrials.gov
What's tested:Fiber

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants with Need for GDM Medication
Measured over From date of randomization until the date of first documented progression (assessed up to 7 months)

Conditions

Gestational Diabetes Mellitus (GDM)

Explore related trials

Gestational Diabetes

Where it's being run

1 sites across 1 states
Virginia1

Study leadership

  • Jerri Waller, MD · PRINCIPAL_INVESTIGATOR · Macon & Joan Brock Virginia Health Sciences at Old Dominion University

Who to contact

Morgan Scaglione, MD
[email protected]
757-446-7900
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

\- 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.

What this trial measures

  • Number of Participants with Need for GDM MedicationFrom date of randomization until the date of first documented progression (assessed up to 7 months)

    The primary outcome is the need for medication (either insulin or oral hypoglycemic agents) for management of gestational diabetes (progression from GDMA1 to GDMA2). We chose this primary outcome because the need for medication is associated with the need for significantly more antenatal interventions due to increased adverse pregnancy outcomes.