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

Eastern Virginia Medical School (EVMS)

Status: Enrolling

Conditions: Gestational Diabetes Mellitus (GDM)

Treatments: Dietary Supplement: Fiber

Study type: Interventional

Funder types: Other

Identifiers

NCT06867861

24-08-FB-0214

Details and patient eligibility

About

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.

Full 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.

Enrollment: 110 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 2 patient groups

Fiber

Experimental group

Description:

Participants will 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:

Dietary Supplement: Fiber

No Fiber

No Intervention group

Description:

Participants will receive no fiber supplementation capsules.