Actively Recruiting
Phase Not Applicable
Age: 18Years - 50Years
FEMALE
ID06867861
Effect of Fiber Supplementation on the Need for Medication With Gestational Diabetes: A Randomized Controlled Trial
Led by Eastern Virginia Medical School · Updated on 2025-03-10
110
Participants Needed
1
Research Sites
26 weeks
Total Duration
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AI-Summary
What this Trial Is 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.
CONDITIONS
Brief Title
Effect of Fiber Supplementation on the Need for Medication With Gestational Diabetes
Who Can Participate
Age: 18Years - 50Years
FEMALE
Eligibility Criteria
You may qualify if you...
- Singleton gestation
- Known or new diagnosis of gestational diabetes without reason for medication
- Age >=18 to <=50
You will not qualify if you...
- - 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.
AI-Screening
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1
2
3
Trial Site Locations
Total: 1 location
1
Macon & Joan Brock Virginia Health Sciences at ODU
Norfolk, Virginia, United States, 23507
Actively Recruiting
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Published Research Related To This Trial
Benefits and harms of treating gestational diabetes mellitus: a systematic review and meta-analysis for the U.S. Preventive Services Task Force and the National Institutes of Health Office of Medical Applications of Research.
Lisa Hartling, Donna M Dryden, Alyssa Guthrie...
https://pubmed.ncbi.nlm.nih.gov/23712381Barriers to insulin initiation: the translating research into action for diabetes insulin starts project.
Andrew J Karter, Usha Subramanian, Chandan Saha...
https://pubmed.ncbi.nlm.nih.gov/20086256Beneficial effects of high dietary fiber intake in patients with type 2 diabetes mellitus.
M Chandalia, A Garg, D Lutjohann...
https://pubmed.ncbi.nlm.nih.gov/10805824Effects of psyllium on glucose and serum lipid responses in men with type 2 diabetes and hypercholesterolemia.
J W Anderson, L D Allgood, J Turner...
https://pubmed.ncbi.nlm.nih.gov/10500014Effects of Additional Dietary Fiber Supplements on Pregnant Women with Gestational Diabetes: A Systematic Review and Meta-Analysis of Randomized Controlled Studies.
Jihan Sun, Jinjing Wang, Wenqing Ma...
https://pubmed.ncbi.nlm.nih.gov/36364883Effect of treatment of gestational diabetes mellitus on pregnancy outcomes.
Caroline A Crowther, Janet E Hiller, John R Moss...
https://pubmed.ncbi.nlm.nih.gov/15951574