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

Effect of Fiber Supplementation on the Need for Medication with Gestational Diabetes: a Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Gestational Diabetes Mellitus (GDM)
• Intervention / Treatment: Dietary supplement: Fiber

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 Type: Interventional
• Enrollment (Estimated): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Recruiting
      • Macon & Joan Brock Virginia Health Sciences at ODU
      • Contact: Morgan Scaglione, MD; Phone Number: 757-446-7900; Email: scaglima@odu.edu
      • Contact: Kristin Ayers, MPH; Phone Number: 757-446-7900; Email: ayerskl@odu.edu
      • Contact: Jerri Waller, MD
      • Contact: Morgan Scaglione, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fiber; Participants will psyllium fiber supplement capsules, 2g soluble fiber per capsule. They will be instructed to take 4 capsules twice daily for a total of 16g supplemental soluble fiber per day. This will be continued throughout pregnancy.	Dietary supplement: Fiber; Psyllium fiber supplement capsules, 2g soluble fiber per capsule. They will be instructed to take 4 capsules twice daily for a total of 16g supplemental soluble fiber per day. This will be continued throughout pregnancy.
No Intervention: No Fiber; Participants will receive no fiber supplementation capsules.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Need for GDM Medication	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.	From date of randomization until the date of first documented progression (assessed up to 7 months)

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Eastern Virginia Medical School
• Investigators: Principal Investigator: Jerri Waller, MD, Macon & Joan Brock Virginia Health Sciences at Old Dominion University

Publications and helpful links

General Publications

• 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.
• ACOG Practice Bulletin No. 190: Gestational Diabetes Mellitus. Obstet Gynecol. 2018 Feb;131(2):e49-e64. doi: 10.1097/AOG.0000000000002501.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2025
• Primary Completion (Estimated): February 24, 2026
• Study Completion (Estimated): August 26, 2026

Study Registration Dates

• First Submitted: February 28, 2025
• First Submitted That Met QC Criteria: March 5, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 5, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Fiber; GDM; Gestational Diabetes Mellitus
• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Female Urogenital Diseases and Pregnancy Complications; Metabolic Diseases; Pregnancy Complications; Glucose Metabolism Disorders; Diabetes, Gestational; Diabetes Mellitus
• Other Study ID Numbers: 24-08-FB-0214

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No