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

Eastern Virginia Medical School110 enrolled

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

110

Conditions

Gestational Diabetes Mellitus (GDM)

Interventions

FiberDIETARY_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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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.

Locations (1)

Macon & Joan Brock Virginia Health Sciences at ODU

Norfolk, Virginia, United States

RECRUITING

Outcomes

Primary Outcomes

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

Hgb A1c at delivery

Measurement of Hgb A1c

Time frame: At delivery

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)

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)

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)

Number of Participants with Placental Abruption

Number of participants with placental abruption

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

Mode of Delivery

Data from ClinicalTrials.gov

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