NCT06867861

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
3mo left

Started Feb 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress80%
Feb 2025Aug 2026

Study Start

First participant enrolled

February 24, 2025

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

February 28, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 10, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 24, 2026

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 26, 2026

Expected
Last Updated

March 10, 2025

Status Verified

March 1, 2025

Enrollment Period

1 year

First QC Date

February 28, 2025

Last Update Submit

March 5, 2025

Conditions

Gestational Diabetes Mellitus (GDM)

Keywords

Gestational Diabetes MellitusFiberGDM

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (18)

  • Hgb A1c at delivery

    At delivery

  • 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

    From date of randomization until the date of first documented progression (assessed up to 7 months)

  • 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

    From date of randomization until the date of first documented progression (assessed up to 7 months)

  • +13 more secondary outcomes

Study Arms (2)

Fiber

EXPERIMENTAL

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

No Fiber

NO INTERVENTION

Participants will receive no fiber supplementation capsules.

Interventions

FiberDIETARY_SUPPLEMENT

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.

Fiber

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Singleton gestation
  • Known or new diagnosis of gestational diabetes without reason for medication
  • Age \>=18 to \<=50

You may not qualify if:

  • \- 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Macon & Joan Brock Virginia Health Sciences at ODU

Norfolk, Virginia, 23507, United States

RECRUITING

Related Publications (8)

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

    PMID: 29370047BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 23712381BACKGROUND

  • 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.

    PMID: 20086256BACKGROUND

  • 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.

    PMID: 10805824BACKGROUND

  • 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.

    PMID: 10500014BACKGROUND

  • 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.

    PMID: 36364883BACKGROUND

  • 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.

    PMID: 15951574BACKGROUND

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

Dietary Fiber

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Dietary CarbohydratesCarbohydratesFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Jerri Waller, MD

    Macon & Joan Brock Virginia Health Sciences at Old Dominion University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 28, 2025

First Posted

March 10, 2025

Study Start

February 24, 2025

Primary Completion

February 24, 2026

Study Completion (Estimated)

August 26, 2026

Last Updated

March 10, 2025

Record last verified: 2025-03

Locations

US(1)