Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2026-02-13 @ 12:24 PM
Study NCT ID:
NCT03138902
Status:
COMPLETED
Last Update Posted:
2017-05-03
First Post:
2017-04-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Carbohydrate Intolerance Questionnaire Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C562602', 'term': 'Glucose-Galactose Malabsorption'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 108}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2013-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-02', 'studyFirstSubmitDate': '2017-04-25', 'studyFirstSubmitQcDate': '2017-05-02', 'lastUpdatePostDateStruct': {'date': '2017-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete a Carbohydrate Intolerance Questionnaire (CIQ)', 'timeFrame': '1 day', 'description': 'Primary Outcome'}, {'measure': 'Complete a 2 Hour Oral Glucose Tolerance Test (OGTT) to measure glucose response', 'timeFrame': '2 hours', 'description': 'Primary Outcome'}, {'measure': 'Complete a 2 Hour Oral Glucose Tolerance Test (OGTT) to measure insulin response', 'timeFrame': '2 hours', 'description': 'Primary Outcome'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Carbohydrate Intolerance']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the validity of using a carbohydrate intolerance questionnaire (CIQ) and/or other health markers as a means of predicting response to insulin sensitivity as determined by an oral glucose tolerance test (OGTT).', 'detailedDescription': 'This study will utilize a carbohydrate intolerance questionnaire (CIQ). Responses to a CIQ will be correlated with diet inventories, baseline body composition and health assessments, a standard metabolic panel, fasting glucose and insulin levels, a homeostatic insulin resistance model (HOMA), a two hour oral glucose tolerance test (OGTT), and a carbohydrate sensitivity symptom questionnaire administered during the OGTT.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Females were requested by the Sponsor', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participant is female\n* Participant is between the ages of 18 and 60\n\nExclusion Criteria:\n\n* Participant is pregnant or nursing\n* Participant is diabetic or pre-diabetic\n* Participant has a Body Mass Index (BMI) \\< 22'}, 'identificationModule': {'nctId': 'NCT03138902', 'acronym': 'Curves1', 'briefTitle': 'Carbohydrate Intolerance Questionnaire Study', 'organization': {'class': 'OTHER', 'fullName': 'Texas A&M University'}, 'officialTitle': 'Validation of Carbohydrate Intolerance Questionnaire', 'orgStudyIdInfo': {'id': 'IRB2013-0401'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Glucose Tolerance Beverage', 'description': '75 g. of a fruit punch flavored oral glucose solution', 'interventionNames': ['Dietary Supplement: TRUTOL Glucose Tolerance Beverage']}], 'interventions': [{'name': 'TRUTOL Glucose Tolerance Beverage', 'type': 'DIETARY_SUPPLEMENT', 'description': 'A caffeine-free, non-carbonated, glucose tolerance beverage', 'armGroupLabels': ['Glucose Tolerance Beverage']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Richard B Kreider, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Texas A&M University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Texas A&M University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Curves International', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}