Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-25 @ 11:53 PM
Study NCT ID:
NCT04003194
Status:
COMPLETED
Last Update Posted:
2019-07-01
First Post:
2019-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pinto Beans and Glycemic Control in Adults With Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Crossover Assignment Crossover design with 2-12 week intervention and comparator phases separated by a 4-week washout.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2010-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-28', 'studyFirstSubmitDate': '2019-06-24', 'studyFirstSubmitQcDate': '2019-06-28', 'lastUpdatePostDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2010-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Glucose', 'timeFrame': '12 weeks pre and post', 'description': 'Change in fasting blood glucose levels'}], 'secondaryOutcomes': [{'measure': 'Postprandial glucose', 'timeFrame': '1 time per week from week 1 of each intervention to week 12 of each intervention', 'description': '1 time per week from week 1 of each intervention to week 12 of each intervention'}, {'measure': 'Change in Hemoglobin A1c', 'timeFrame': '12 weeks pre and post', 'description': 'Change in Blood hemoglobin A1c'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pulses', 'legumes', 'Phaseolus vulgaris L.', 'glycemic response'], 'conditions': ['Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'This study examines the impact of daily consumption of ½ c pinto beans, compared to a control (½ c green beans), on fasting glucose, postprandial glucose and HbA1c concentrations in adults with type 2 diabetes mellitus (T2DM).', 'detailedDescription': 'This study utilized a randomized, pretest-posttest, crossover (within-group) design, that includes two treatment periods \\[control period (½ c. green beans each day) and pinto beans (½ c each day)\\], each 12-weeks in duration with a 4- week wash-out period to determine the impact on fasting glucose, postprandial glucose and HbA1c concentrations. After a baseline wash-in period, 16 participants are randomly assigned to 2 treatment periods \\[control period and pinto beans\\], each 12-weeks in duration. On 28 randomized days during the wash-in period and interventions, participants keep diet records and measure a postprandial capillary glucose concentration using a glucometer 1 hour after the meal during which the pinto beans or control are consumed. Before and after each 12-week intervention, participants provide a fasted venous blood sample for glucose and HbA1c analyses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosis of T2DM by a physician;\n* currently attempting control of T2DM by diet or metformin;\n* fasting glucose ≥ 90 mg/dL (confirmed by fasting blood draw or potential participant provided lab analysis conducted within last 30 days) and/or hemoglobin A1C ≥ 6.5% (confirmed by blood draw or potential participant provided lab analysis conducted within last 30 days);\n* body mass index (BMI) of 22-40 kg/m2;\n* no unresolved health conditions and no diagnosis of gastrointestinal disease;\n* limited history of legume intake;\n* willingness to follow study protocol, scheduling, and ability to come to the testing location;\n* no recent weight gain or loss (\\>10% over 6 months);\n* no use of medications and/or dietary supplements other than metformin that affected glucose;\n* women could not be pregnant or breastfeeding;\n* habitual alcohol consumption had to be less than 2 drinks per day (specifically ≤ 720 ml of beer, 240 ml of wine, or 90 ml of hard liquor).\n\nExclusion Criteria:\n\n* Non compliance with above inclusion criteria.'}, 'identificationModule': {'nctId': 'NCT04003194', 'briefTitle': 'Pinto Beans and Glycemic Control in Adults With Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Colorado Springs'}, 'officialTitle': 'Impact of Pinto Beans as Part of a Normal Diet on Glycemic Control in Adults With Type 2 Diabetes: a Randomized Trial', 'orgStudyIdInfo': {'id': 'UCCS09-028'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pinto beans', 'description': '1/2 cup pinto beans eaten daily by free-living individuals for 12 consecutive weeks.', 'interventionNames': ['Other: Pinto Beans']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Green beans', 'description': '1/2 cup green beans eaten daily by free-living individuals for 12 consecutive weeks.', 'interventionNames': ['Other: Green Beans - control']}], 'interventions': [{'name': 'Pinto Beans', 'type': 'OTHER', 'otherNames': ['Pinto Beans - intervention'], 'description': 'The intervention was 1/2 cup of pinto beans each day.', 'armGroupLabels': ['Pinto beans']}, {'name': 'Green Beans - control', 'type': 'OTHER', 'otherNames': ['Control'], 'description': 'The control was 1/2 cup of green beans each day.', 'armGroupLabels': ['Green beans']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Colorado Springs', 'class': 'OTHER'}, 'collaborators': [{'name': 'Iowa State University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Andrea Hutchins', 'investigatorAffiliation': 'University of Colorado, Colorado Springs'}}}}