Clinical trial NCT06867861: Effect of Fiber Supplementation on the Need for Medication With Gestational Diabetes
Official title: Effect of Fiber Supplementation on the Need for Medication With Gestational Diabetes: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gestational Diabetes Mellitus (GDM)
Keywords: Gestational Diabetes Mellitus
Fiber
GDM
Lead sponsor: Eastern Virginia Medical School
Sponsor class: OTHER
First posted: 2025-03-10
Enrollment: 110
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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.

Primary outcomes:
measure: Number of Participants with Need for GDM Medication
timeFrame: From date of randomization until the date of first documented progression (assessed up to 7 months)
Secondary outcomes:
measure: Hgb A1c at delivery
timeFrame: At delivery
measure: Rate of Fetal Demise
timeFrame: From date of randomization until the date of documented occurrence (assessed up to 7 months)
measure: Number of Participants Diagnosed with Fetal Growth Restriction
timeFrame: From date of randomization until the date of first documented progression (assessed up to 7 months)
measure: Number of Participants Diagnosed with Preeclampsia
timeFrame: From date of randomization until the date of first documented progression (assessed up to 7 months)
measure: Number of Participants with Placental Abruption
timeFrame: From date of randomization until the date of first documented progression (assessed up to 7 months)
measure: Mode of Delivery
timeFrame: At delivery
measure: Indication for Cesarean Delivery
timeFrame: At delivery
measure: Rate of Shoulder Dystocia
timeFrame: At delivery
measure: Quantitative Blood Loss
timeFrame: At delivery
measure: Rate of Postpartum Hemorrhage
timeFrame: At delivery
measure: Rates of Infection
timeFrame: Delivery until discharge (assessed up to 5 days)
measure: Birth Weight
timeFrame: At delivery
measure: Apgar Score
timeFrame: At delivery
measure: Rates of Neonatal Infections
timeFrame: Delivery until discharge (assessed up to 5 days)
measure: Rate of Respiratory Distress Syndrome
timeFrame: At delivery
measure: Rate of Necrotizing Enterocolitis
timeFrame: Delivery until discharge (assessed up to 5 days)
measure: Rate of NICU Admission
timeFrame: Delivery until discharge (assessed up to 5 days)
measure: Days in NICU
timeFrame: Delivery until discharge of the neonate (assessed up to 180 days)
Other outcomes:
Locations:
city: Norfolk
country: United States
facility: Macon & Joan Brock Virginia Health Sciences at ODU
state: Virginia
Study officials:
affiliation: Macon & Joan Brock Virginia Health Sciences at Old Dominion University
name: Jerri Waller, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: ACOG Practice Bulletin No. 190: Gestational Diabetes Mellitus. Obstet Gynecol. 2018 Feb;131(2):e49-e64. doi: 10.1097/AOG.0000000000002501.
citation: Landon MB, Spong CY, Thom E, Carpenter MW, Ramin SM, Casey B, et al. A multicenter, randomized trial of treatment for mild gestational diabetes. Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. N Engl J Med 2009;361:1139-48.
citation: Hartling L, Dryden DM, Guthrie A, Muise M, Vandermeer B, Donovan L. 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. Ann Intern Med. 2013 Jul 16;159(2):123-9. doi: 10.7326/0003-4819-159-2-201307160-00661.
citation: Karter AJ, Subramanian U, Saha C, Crosson JC, Parker MM, Swain BE, Moffet HH, Marrero DG. Barriers to insulin initiation: the translating research into action for diabetes insulin starts project. Diabetes Care. 2010 Apr;33(4):733-5. doi: 10.2337/dc09-1184. Epub 2010 Jan 19.
citation: Chandalia M, Garg A, Lutjohann D, von Bergmann K, Grundy SM, Brinkley LJ. Beneficial effects of high dietary fiber intake in patients with type 2 diabetes mellitus. N Engl J Med. 2000 May 11;342(19):1392-8. doi: 10.1056/NEJM200005113421903.
citation: Anderson JW, Allgood LD, Turner J, Oeltgen PR, Daggy BP. Effects of psyllium on glucose and serum lipid responses in men with type 2 diabetes and hypercholesterolemia. Am J Clin Nutr. 1999 Oct;70(4):466-73. doi: 10.1093/ajcn/70.4.466.
citation: Sun J, Wang J, Ma W, Miao M, Sun G. Effects of Additional Dietary Fiber Supplements on Pregnant Women with Gestational Diabetes: A Systematic Review and Meta-Analysis of Randomized Controlled Studies. Nutrients. 2022 Nov 2;14(21):4626. doi: 10.3390/nu14214626.
citation: Crowther CA, Hiller JE, Moss JR, McPhee AJ, Jeffries WS, Robinson JS; Australian Carbohydrate Intolerance Study in Pregnant Women (ACHOIS) Trial Group. Effect of treatment of gestational diabetes mellitus on pregnancy outcomes. N Engl J Med. 2005 Jun 16;352(24):2477-86. doi: 10.1056/NEJMoa042973. Epub 2005 Jun 12.