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Gestational Diabetes Mellitus (GDM)NCT06867861

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

A study testing Fiber in people with Gestational Diabetes Mellitus (GDM), run by Eastern Virginia Medical School at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 years, women only
Conditions the study is for
Gestational Diabetes Mellitus (GDM)
What is being tested?
Fiber
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
1 siteUnited States
Study dates
24 Feb 2025to 26 Aug 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

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

Who cannot join

  • - 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site, 1 recruiting

  • Macon & Joan Brock Virginia Health Sciences at ODU

    Norfolk, Virginia, 23507

    Morgan Scaglione, MD, 757-446-7900, scaglima@odu.edu

    Kristin Ayers, MPH, 757-446-7900, ayerskl@odu.edu

    Recruiting

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Fiber
Keywords
Gestational Diabetes Mellitus, Fiber, GDM
Medical subject headings
Diabetes, Gestational

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT06867861
Study groupRoleWhat they receive
FiberExperimentalParticipants 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.
Receives: Dietary Supplement: Fiber
No FiberNo interventionParticipants will receive no fiber supplementation capsules.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (18)

  1. Hgb A1c at delivery

    Measurement of Hgb A1c

    Measured: At delivery

  2. Rate of Fetal Demise

    Rate of fetal demise

    Measured: From date of randomization until the date of documented occurrence (assessed up to 7 months)

  3. Number of Participants Diagnosed with Fetal Growth Restriction

    Number of participants diagnosed with fetal growth restriction

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

  4. Number of Participants Diagnosed with Preeclampsia

    Number of participants diagnosed with preeclampsia

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

  5. Number of Participants with Placental Abruption

    Number of participants with placental abruption

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

  6. Mode of Delivery

    Rates of cesarean and vaginal deliveries

    Measured: At delivery

  7. Indication for Cesarean Delivery

    Rates of each indication for cesarean delivery

    Measured: At delivery

  8. Rate of Shoulder Dystocia

    Rate of shoulder dystocia

    Measured: At delivery

  9. Quantitative Blood Loss

    Blood loss in mL

    Measured: At delivery

  10. Rate of Postpartum Hemorrhage

    Rates of patients with quantitative blood loss > 1000mL

    Measured: At delivery

  11. Rates of Infection

    Rates of infection

    Measured: Delivery until discharge (assessed up to 5 days)

  12. Birth Weight

    Birth weight

    Measured: At delivery

  13. Apgar Score

    Apgar scores at delivery on a scale of 0 to 10, with higher scores meaning a better outcome

    Measured: At delivery

  14. Rates of Neonatal Infections

    Rates of neonatal infections

    Measured: Delivery until discharge (assessed up to 5 days)

  15. Rate of Respiratory Distress Syndrome

    Rate of respiratory distress syndrome

    Measured: At delivery

  16. Rate of Necrotizing Enterocolitis

    Rate of necrotizing enterocolitis

    Measured: Delivery until discharge (assessed up to 5 days)

  17. Rate of NICU Admission

    Rate of admission to NICU

    Measured: Delivery until discharge (assessed up to 5 days)

  18. Days in NICU

    Days spent in NICU

    Measured: Delivery until discharge of the neonate (assessed up to 180 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2025
  2. Study start24 Feb 2025
  3. Primary completion24 Feb 2026 (estimated)
  4. Study completion26 Aug 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
110 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06867861
Sponsor's protocol ID
24-08-FB-0214
Status last verified
Mar 2025
First submitted
28 Feb 2025
Last updated
10 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

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

    PubMed 29370047

  • 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.

  • 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.

    PubMed 23712381

  • 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.

    PubMed 20086256

  • 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.

    PubMed 10805824

  • 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.

    PubMed 10500014

  • 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.

    PubMed 36364883

  • 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.

    PubMed 15951574

Questions about this trial

What is this clinical trial studying?

A study testing Fiber in people with Gestational Diabetes Mellitus (GDM), run by Eastern Virginia Medical School at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Need for GDM Medication (time frame: From date of randomization until the date of first documented progression (assessed up to 7 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06867861, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2025.

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