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NCT06867861 · ClinicalTrials.gov registry record · NA
Effect of Fiber Supplementation on the Need for Medication With Gestational Diabetes
A NA study of Gestational Diabetes Mellitus (GDM), sponsored by Eastern Virginia Medical School.
- Recruiting
- Registry status
- NA
- Development phase
- 110
- Enrollment target
- 1
- Study location
NCT06867861: Recruiting NA study of Gestational Diabetes Mellitus (GDM), sponsored by Eastern Virginia Medical School.
NCT06867861 is a NA study of Gestational Diabetes Mellitus (GDM) that is actively recruiting participants, run by Eastern Virginia Medical School. The registered enrollment target is 110 participants, below the 816-participant average among 4 other Gestational Diabetes Mellitus (GDM) trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06867861, a NA study of Gestational Diabetes Mellitus (GDM), is actively recruiting participants, sponsored by Eastern Virginia Medical School.
- RECRUITING
- Registry status
- NA
- Development phase
- 110 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Fiber
Study Locations (1)
Virginia
- Macon & Joan Brock Virginia Health Sciences at ODU - Norfolk
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 110 participants |
| Start Date | 2025-02-24 |
| Est. Completion | 2026-08-26 |
| Phase | NA |
What NCT06867861 shows while recruiting
NCT06867861 is an interventional study that assigns participants to a tested intervention. The registered 110 participants enrollment target is mid-sized for trials with a published cap, below the 816-participant average among 4 other Gestational Diabetes Mellitus (GDM) trials with a reported enrollment target (87% lower).
The record links to 1 condition, with Gestational Diabetes Mellitus (GDM) appearing as the primary indexed condition, and to 1 intervention - of which Fiber is the first listed.
NCT06867861 reports a single indexed study location in Virginia.
Frequently Asked Questions
What is clinical trial NCT06867861 about?
NCT06867861 is a clinical study titled "Effect of Fiber Supplementation on the Need for Medication With Gestational Diabetes". 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 contro...
What is the current status of trial NCT06867861?
This trial is currently recruiting. It is a NA study. The enrollment target is 110 participants. The study started on 2025-02-24. Estimated completion is 2026-08-26.
What conditions does trial NCT06867861 study?
This clinical trial studies the following conditions: Gestational Diabetes Mellitus (GDM).
What interventions are being tested in trial NCT06867861?
The interventions under investigation include: Fiber (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT06867861?
This trial is sponsored by Eastern Virginia Medical School, which has 36 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06867861 being conducted?
This trial has 1 study location across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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