Health TrialsbyHealthPanel

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

ConditionGestational Diabetes Mellitus (GDM)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorEastern Virginia Medical School

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Singleton gestation

Known or new diagnosis of gestational diabetes without reason for medication

Age >=18 to <=50

Disqualifiers

- Non-English as primary language.

Known or suspected fetal anomaly or aneuploidy.

Known lower bowel disorder

Known phenylketonuria

Trial design

Design model

Parallel

Treatments tested in this trial

  • Fiber

    Dietary supplement

    Psyllium fiber supplement capsules, 2g soluble fiber per capsule. They will be instructed to take 4 capsules twice daily for a total of 16g supplemental soluble fiber per day. This will be continued throughout pregnancy.

Treatment groups

110 Participants
are divided into 2 treatment groups
Group A: FiberExperimental treatment 1 intervention
Group B: No FiberNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Number of Participants with Need for GDM Medication

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.

Time frame
From date of randomization until the date of first documented progression (assessed up to 7 months)

Secondary outcomes

1

Hgb A1c at delivery

Measurement of Hgb A1c

Time frame
At delivery
2

Rate of Fetal Demise

Rate of fetal demise

Time frame
From date of randomization until the date of documented occurrence (assessed up to 7 months)
3

Number of Participants Diagnosed with Fetal Growth Restriction

Number of participants diagnosed with fetal growth restriction

Time frame
From date of randomization until the date of first documented progression (assessed up to 7 months)
4

Number of Participants Diagnosed with Preeclampsia

Number of participants diagnosed with preeclampsia

Time frame
From date of randomization until the date of first documented progression (assessed up to 7 months)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Eastern Virginia Medical School

Lead sponsor

Source ClinicalTrials.gov
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