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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| No Fiber | No Intervention | Participants will receive no fiber supplementation capsules. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fiber | Dietary 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. |
| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jerri Waller, MD | Macon & Joan Brock Virginia Health Sciences at Old Dominion University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Macon & Joan Brock Virginia Health Sciences at ODU | Recruiting | Norfolk | Virginia | 23507 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29370047 | Background | ACOG Practice Bulletin No. 190: Gestational Diabetes Mellitus. Obstet Gynecol. 2018 Feb;131(2):e49-e64. doi: 10.1097/AOG.0000000000002501. | |
| Background | 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. | ||
| 23712381 |
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| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003920 | Diabetes Mellitus |
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| ID | Term |
|---|---|
| D004043 | Dietary Fiber |
| ID | Term |
|---|---|
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
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| 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) |
| 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. |
| 20086256 | Background | 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. |
| 10805824 | Background | 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. |
| 10500014 | Background | 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. |
| 36364883 | Background | 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. |
| 15951574 | Background | 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. |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D010829 |
| Physiological Phenomena |
| D019602 | Food and Beverages |