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

Not Applicable

Recruiting

• Conditions: Gestational Diabetes Mellitus (GDM)

• Registration Number: NCT06867861
• Lead Sponsor: Eastern Virginia Medical School

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2025-02-24
• Study First Submitted: 2025-02-28
• Status Verified: 2025-03
• Study First Submitted QC: 2025-03-05
• Last Update Submitted: 2025-03-05
• Study First Posted: 2025-03-10
• Last Update Posted: 2025-03-10
• Primary Completion: 2026-02-24
• Study Completion: 2026-08-26

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 110

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of Participants with Need for GDM Medication	From 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.

Secondary Outcome Measures

Name	Time	Method
Hgb A1c at delivery	At delivery	Measurement of Hgb A1c
Rate of Fetal Demise	From date of randomization until the date of documented occurrence (assessed up to 7 months)	Rate of fetal demise
Number of Participants Diagnosed with Fetal Growth Restriction	From date of randomization until the date of first documented progression (assessed up to 7 months)	Number of participants diagnosed with fetal growth restriction
Number of Participants Diagnosed with Preeclampsia	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 with Placental Abruption	From date of randomization until the date of first documented progression (assessed up to 7 months)	Number of participants with placental abruption
Mode of Delivery	At delivery	Rates of cesarean and vaginal deliveries
Indication for Cesarean Delivery	At delivery	Rates of each indication for cesarean delivery
Quantitative Blood Loss	At delivery	Blood loss in mL
Rate of Postpartum Hemorrhage	At delivery	Rates of patients with quantitative blood loss \> 1000mL
Rate of Shoulder Dystocia	At delivery	Rate of shoulder dystocia
Rates of Infection	Delivery until discharge (assessed up to 5 days)	Rates of infection
Birth Weight	At delivery	Birth weight
Apgar Score	At delivery	Apgar scores at delivery on a scale of 0 to 10, with higher scores meaning a better outcome
Rates of Neonatal Infections	Delivery until discharge (assessed up to 5 days)	Rates of neonatal infections
Rate of Respiratory Distress Syndrome	At delivery	Rate of respiratory distress syndrome
Rate of Necrotizing Enterocolitis	Delivery until discharge (assessed up to 5 days)	Rate of necrotizing enterocolitis
Rate of NICU Admission	Delivery until discharge (assessed up to 5 days)	Rate of admission to NICU
Days in NICU	Delivery until discharge of the neonate (assessed up to 180 days)	Days spent in NICU

Trial Locations

Locations (1)

Macon & Joan Brock Virginia Health Sciences at ODU; 🇺🇸 Norfolk, Virginia, United States