Effect of Fiber Supplementation on the Need for Medication With Gestational Diabetes: A Randomized Controlled Trial
Eastern Virginia Medical School
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.
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.
Eligibility
- Age range
- 18–50 years
- Sex
- Female
- Healthy volunteers
- No
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.
Interventions
- Dietary SupplementFiber
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.
Location
- Macon & Joan Brock Virginia Health Sciences at ODUNorfolk, Virginia