Ignite Creation Date:
2025-12-24 @ 7:59 PM
Ignite Modification Date:
2025-12-29 @ 9:14 AM
Study NCT ID:
NCT00911404
Status:
COMPLETED
Last Update Posted:
2016-08-23
First Post:
2009-05-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Carbohydrate Restriction for Gestational Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016640', 'term': 'Diabetes, Gestational'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], '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'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 152}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-20', 'studyFirstSubmitDate': '2009-05-28', 'studyFirstSubmitQcDate': '2009-05-28', 'lastUpdatePostDateStruct': {'date': '2016-08-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-06-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Need of insulin treatment for GDM', 'timeFrame': 'Day of delivery'}], 'secondaryOutcomes': [{'measure': 'Time from GDM diagnosis free of insulin treatment', 'timeFrame': 'Day of delivery'}, {'measure': 'Maternal ketonemia and/or ketonuria', 'timeFrame': 'Day of delivery'}, {'measure': 'Maternal morbidity', 'timeFrame': 'Day of delivery'}, {'measure': 'Fetal morbidity', 'timeFrame': '1 month after delivery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Gestational diabetes', 'Carbohydrate', 'Diet', 'Insulin'], 'conditions': ['Gestational Diabetes Mellitus (GDM)']}, 'referencesModule': {'references': [{'pmid': '18058723', 'type': 'BACKGROUND', 'citation': 'Cypryk K, Kaminska P, Kosinski M, Pertynska-Marczewska M, Lewinski A. A comparison of the effectiveness, tolerability and safety of high and low carbohydrate diets in women with gestational diabetes. Endokrynol Pol. 2007 Jul-Aug;58(4):314-9.'}, {'pmid': '1748252', 'type': 'BACKGROUND', 'citation': 'Peterson CM, Jovanovic-Peterson L. Percentage of carbohydrate and glycemic response to breakfast, lunch, and dinner in women with gestational diabetes. Diabetes. 1991 Dec;40 Suppl 2:172-4. doi: 10.2337/diab.40.2.s172.'}, {'pmid': '9540949', 'type': 'BACKGROUND', 'citation': 'Major CA, Henry MJ, De Veciana M, Morgan MA. The effects of carbohydrate restriction in patients with diet-controlled gestational diabetes. Obstet Gynecol. 1998 Apr;91(4):600-4. doi: 10.1016/s0029-7844(98)00003-9.'}, {'pmid': '23564917', 'type': 'DERIVED', 'citation': 'Moreno-Castilla C, Hernandez M, Bergua M, Alvarez MC, Arce MA, Rodriguez K, Martinez-Alonso M, Iglesias M, Mateu M, Santos MD, Pacheco LR, Blasco Y, Martin E, Balsells N, Aranda N, Mauricio D. Low-carbohydrate diet for the treatment of gestational diabetes mellitus: a randomized controlled trial. Diabetes Care. 2013 Aug;36(8):2233-8. doi: 10.2337/dc12-2714. Epub 2013 Apr 5.'}]}, 'descriptionModule': {'briefSummary': "There is evidence that controlling total amount of carbohydrates is a strategy for controlling glucose levels in diabetes mellitus. There is not major evidence that any given macronutrient percentage may be recommended to treat a woman with Gestational Diabetes Mellitus (GDM). In the investigators' country, insulin is the second-line treatment once medical nutrition therapy (MNT) has failed to control glucose levels during pregnancy. Insulin treatment is more expensive and not as well accepted as MNT. The investigators have designed a randomized-controlled trial to assess whether a diet with 40% total calories from carbohydrates may reduce the need of insulin treatment in women with gestational diabetes, without having unfavourable pregnancy outcomes, in comparison with a diet with 55% total calories from carbohydrates."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Gestational diabetes mellitus\n* Single pregnancy\n\nExclusion Criteria:\n\n* Multiple pregnancy\n* High risk pregnancy (any other concomitant illness, excluding hypertension and obesity)\n* Low ability to understand and follow a diet\n* Need to use insulin different from regular insulin'}, 'identificationModule': {'nctId': 'NCT00911404', 'acronym': 'LO-CA', 'briefTitle': 'Carbohydrate Restriction for Gestational Diabetes Mellitus', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Arnau de Vilanova'}, 'officialTitle': 'Comparison of Two Different Diets Containing Different Proportions of Carbohydrates in the Treatment of Gestational Diabetes Mellitus: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'CEIC-670'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low CHO', 'description': 'Diet with 40% total calories from carbohydrates.', 'interventionNames': ['Behavioral: Low CHO']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'High CHO', 'description': 'Diet with 55% total calories from carbohydrates.', 'interventionNames': ['Dietary Supplement: High CHO diet']}], 'interventions': [{'name': 'Low CHO', 'type': 'BEHAVIORAL', 'description': 'Diet with 40% total calories from carbohydrates. In the "Low-CHO" arm, 15% of calories from carbohydrates will be substituted by monounsaturated fat.', 'armGroupLabels': ['Low CHO']}, {'name': 'High CHO diet', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Diet with 55% total calories from carbohydrates.', 'armGroupLabels': ['High CHO']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25198', 'city': 'Lleida', 'state': 'Lleida', 'country': 'Spain', 'facility': 'Hospital Universitari Arnau de Vilanova', 'geoPoint': {'lat': 41.61674, 'lon': 0.62218}}], 'overallOfficials': [{'name': 'Didac Mauricio, MD PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hospital Universitari Arnau de Vilanova'}, {'name': 'Marta Hernández, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitari Arnau de Vilanova'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Arnau de Vilanova', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Marta Hernández García', 'investigatorAffiliation': 'Hospital Arnau de Vilanova'}}}}