Impact of fiber on medication needs in gestational diabetes
Effect of Fiber Supplementation on the Need for Medication With Gestational Diabetes: A Randomized Controlled Trial
NA · Eastern Virginia Medical School · NCT06867861
This study is testing if taking fiber supplements can help women with gestational diabetes need less medication during their pregnancy.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | Eastern Virginia Medical School (other) |
| Locations | 1 site (Norfolk, Virginia) |
| Trial ID | NCT06867861 on ClinicalTrials.gov |
What this trial studies
This study investigates whether fiber supplementation can reduce the need for medication in women diagnosed with gestational diabetes mellitus (GDM). It is a randomized controlled trial where participants with singleton pregnancies and diet-controlled GDM will be assigned to either receive fiber supplements or not. The aim is to evaluate the effects of fiber on both medication requirements and maternal and neonatal health outcomes. Randomization will be conducted using a computer-generated number system to ensure unbiased results.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 to 50 with a singleton pregnancy and a new diagnosis of diet-controlled gestational diabetes.
Not a fit: Patients with known fetal anomalies, bowel disorders, or those who manage diabetes outside the designated medical institution may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help reduce medication use and improve health outcomes for mothers and their babies during pregnancy.
How similar studies have performed: While the approach of using fiber supplementation in gestational diabetes is promising, it is relatively novel and has not been extensively tested in previous studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Norfolk, Virginia
- Macon & Joan Brock Virginia Health Sciences at ODU — Norfolk, Virginia, United States (RECRUITING)
Study contacts
- Principal investigator: Jerri Waller, MD — Macon & Joan Brock Virginia Health Sciences at Old Dominion University
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Gestational Diabetes Mellitus, Fiber, GDM