Ignite Creation Date:
2025-12-24 @ 12:36 PM
Ignite Modification Date:
2025-12-27 @ 10:43 PM
Study NCT ID:
NCT06867861
Status:
RECRUITING
Last Update Posted:
2025-03-10
First Post:
2025-02-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Fiber Supplementation on the Need for Medication With Gestational Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016640', 'term': 'Diabetes, Gestational'}], 'ancestors': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004043', 'term': 'Dietary Fiber'}], 'ancestors': [{'id': 'D004040', 'term': 'Dietary Carbohydrates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 110}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-08-26', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-05', 'studyFirstSubmitDate': '2025-02-28', 'studyFirstSubmitQcDate': '2025-03-05', 'lastUpdatePostDateStruct': {'date': '2025-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-24', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with Need for GDM Medication', 'timeFrame': 'From date of randomization until the date of first documented progression (assessed up to 7 months)', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Hgb A1c at delivery', 'timeFrame': 'At delivery', 'description': 'Measurement of Hgb A1c'}, {'measure': 'Rate of Fetal Demise', 'timeFrame': 'From date of randomization until the date of documented occurrence (assessed up to 7 months)', 'description': 'Rate of fetal demise'}, {'measure': 'Number of Participants Diagnosed with Fetal Growth Restriction', 'timeFrame': 'From date of randomization until the date of first documented progression (assessed up to 7 months)', 'description': 'Number of participants diagnosed with fetal growth restriction'}, {'measure': 'Number of Participants Diagnosed with Preeclampsia', 'timeFrame': 'From date of randomization until the date of first documented progression (assessed up to 7 months)', 'description': 'Number of participants diagnosed with preeclampsia'}, {'measure': 'Number of Participants with Placental Abruption', 'timeFrame': 'From date of randomization until the date of first documented progression (assessed up to 7 months)', 'description': 'Number of participants with placental abruption'}, {'measure': 'Mode of Delivery', 'timeFrame': 'At delivery', 'description': 'Rates of cesarean and vaginal deliveries'}, {'measure': 'Indication for Cesarean Delivery', 'timeFrame': 'At delivery', 'description': 'Rates of each indication for cesarean delivery'}, {'measure': 'Rate of Shoulder Dystocia', 'timeFrame': 'At delivery', 'description': 'Rate of shoulder dystocia'}, {'measure': 'Quantitative Blood Loss', 'timeFrame': 'At delivery', 'description': 'Blood loss in mL'}, {'measure': 'Rate of Postpartum Hemorrhage', 'timeFrame': 'At delivery', 'description': 'Rates of patients with quantitative blood loss \\> 1000mL'}, {'measure': 'Rates of Infection', 'timeFrame': 'Delivery until discharge (assessed up to 5 days)', 'description': 'Rates of infection'}, {'measure': 'Birth Weight', 'timeFrame': 'At delivery', 'description': 'Birth weight'}, {'measure': 'Apgar Score', 'timeFrame': 'At delivery', 'description': 'Apgar scores at delivery on a scale of 0 to 10, with higher scores meaning a better outcome'}, {'measure': 'Rates of Neonatal Infections', 'timeFrame': 'Delivery until discharge (assessed up to 5 days)', 'description': 'Rates of neonatal infections'}, {'measure': 'Rate of Respiratory Distress Syndrome', 'timeFrame': 'At delivery', 'description': 'Rate of respiratory distress syndrome'}, {'measure': 'Rate of Necrotizing Enterocolitis', 'timeFrame': 'Delivery until discharge (assessed up to 5 days)', 'description': 'Rate of necrotizing enterocolitis'}, {'measure': 'Rate of NICU Admission', 'timeFrame': 'Delivery until discharge (assessed up to 5 days)', 'description': 'Rate of admission to NICU'}, {'measure': 'Days in NICU', 'timeFrame': 'Delivery until discharge of the neonate (assessed up to 180 days)', 'description': 'Days spent in NICU'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gestational Diabetes Mellitus', 'Fiber', 'GDM'], 'conditions': ['Gestational Diabetes Mellitus (GDM)']}, 'referencesModule': {'references': [{'pmid': '29370047', 'type': 'BACKGROUND', 'citation': 'ACOG Practice Bulletin No. 190: Gestational Diabetes Mellitus. Obstet Gynecol. 2018 Feb;131(2):e49-e64. doi: 10.1097/AOG.0000000000002501.'}, {'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '23712381', 'type': 'BACKGROUND', 'citation': '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': '20086256', 'type': 'BACKGROUND', 'citation': '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': '10805824', 'type': 'BACKGROUND', 'citation': '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': '10500014', 'type': 'BACKGROUND', 'citation': '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': '36364883', 'type': 'BACKGROUND', 'citation': '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': '15951574', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Singleton gestation\n* Known or new diagnosis of gestational diabetes without reason for medication\n* Age \\>=18 to \\<=50\n\nExclusion Criteria:\n\n* \\- Non-English as primary language.\n* Known or suspected fetal anomaly or aneuploidy.\n* Known lower bowel disorder\n* Known phenylketonuria\n* Prisoners.\n* Management of diabetes outside of Eastern Virginia Medical School Maternal Fetal Medicine.'}, 'identificationModule': {'nctId': 'NCT06867861', 'briefTitle': 'Effect of Fiber Supplementation on the Need for Medication With Gestational Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Eastern Virginia Medical School'}, 'officialTitle': 'Effect of Fiber Supplementation on the Need for Medication With Gestational Diabetes: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '24-08-FB-0214'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fiber', 'description': '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.', 'interventionNames': ['Dietary Supplement: Fiber']}, {'type': 'NO_INTERVENTION', 'label': 'No Fiber', 'description': 'Participants will receive no fiber supplementation capsules.'}], 'interventions': [{'name': 'Fiber', 'type': 'DIETARY_SUPPLEMENT', 'description': '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.', 'armGroupLabels': ['Fiber']}]}, 'contactsLocationsModule': {'locations': [{'zip': '23507', 'city': 'Norfolk', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Morgan Scaglione, MD', 'role': 'CONTACT', 'email': 'scaglima@odu.edu', 'phone': '757-446-7900'}, {'name': 'Kristin Ayers, MPH', 'role': 'CONTACT', 'email': 'ayerskl@odu.edu', 'phone': '757-446-7900'}, {'name': 'Jerri Waller, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Morgan Scaglione, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Macon & Joan Brock Virginia Health Sciences at ODU', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}], 'overallOfficials': [{'name': 'Jerri Waller, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Macon & Joan Brock Virginia Health Sciences at Old Dominion University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eastern Virginia Medical School', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Jerri Waller', 'investigatorAffiliation': 'Eastern Virginia Medical School'}}}}