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

Overview

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.

Interventions

• 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.

Primary outcome measures

• 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)]

Secondary outcome measures (12)

• Hgb A1c at delivery [Time frame: At delivery]
• Rate of Fetal Demise [Time frame: From date of randomization until the date of documented occurrence (assessed up to 7 months)]
• Number of Participants Diagnosed with Fetal Growth Restriction [Time frame: From date of randomization until the date of first documented progression (assessed up to 7 months)]
• Number of Participants Diagnosed with Preeclampsia [Time frame: From date of randomization until the date of first documented progression (assessed up to 7 months)]
• Number of Participants with Placental Abruption [Time frame: From date of randomization until the date of first documented progression (assessed up to 7 months)]
• Mode of Delivery [Time frame: At delivery]
• Indication for Cesarean Delivery [Time frame: At delivery]
• Rate of Shoulder Dystocia [Time frame: At delivery]
• Quantitative Blood Loss [Time frame: At delivery]
• Rate of Postpartum Hemorrhage [Time frame: At delivery]
• Rates of Infection [Time frame: Delivery until discharge (assessed up to 5 days)]
• Birth Weight [Time frame: At delivery]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Prevention

Study locations

United States · 1 center

• Macon & Joan Brock Virginia Health Sciences at ODU — Norfolk

Publications

• ACOG Practice Bulletin No. 190: Gestational Diabetes Mellitus. Obstet Gynecol. 2018 Feb;131(2):e49-e64. doi: 10.1097/AOG.0000000000002501. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 15951574

Identifiers

NCT: NCT06867861 · 24-08-FB-0214

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗