Ignite Creation Date:
2025-12-25 @ 2:39 AM
Ignite Modification Date:
2026-03-01 @ 12:32 PM
Study NCT ID:
NCT01850134
Status:
WITHDRAWN
Last Update Posted:
2016-07-13
First Post:
2013-05-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of a Nutritional Supplement for People With Type 2 Diabetes.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'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': 'D019587', 'term': 'Dietary Supplements'}], 'ancestors': [{'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'}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2013-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-07-12', 'studyFirstSubmitDate': '2013-05-07', 'studyFirstSubmitQcDate': '2013-05-07', 'lastUpdatePostDateStruct': {'date': '2016-07-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-05-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hunger', 'timeFrame': 'Treatment Visit 1 and Treatment Visit 2', 'description': 'An appetite questionnaire evaluating change from baseline during each study visit.'}], 'secondaryOutcomes': [{'measure': 'Fullness', 'timeFrame': 'Treatment Visit 1 and Treatment Visit 2', 'description': 'An appetite questionnaire evaluating change from baseline during each study visit.'}, {'measure': 'Desire to Eat', 'timeFrame': 'Treatment Visit 1 and Treatment Visit 2', 'description': 'An appetite questionnaire evaluating change from baseline during each study visit.'}, {'measure': 'Prospective Consumption', 'timeFrame': 'Treatment Visit 1 and Treatment Visit 2', 'description': 'An appetite questionnaire evaluating change from baseline during each study visit.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes']}, 'descriptionModule': {'briefSummary': 'The objective of this trial is to evaluate a nutritional supplement for people with Diabetes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects will be eligible for the study if they meet all of the following inclusion criteria:\n\n 1. Diagnosis of Type 2 Diabetes.\n 2. Age between 18 and 75 years.\n 3. HbA1c \\> 6.0 but ≤ 8.5\n 4. If female and of childbearing potential , subject is non-pregnant, non- lactating, at least 6 weeks postpartum and agrees to practice birth control throughout study duration.\n 5. BMI \\> 18.5 kg/m2 and \\< 40.0 kg/m2.\n 6. Chronic medication dosage must be stable for at least two months prior to Screening Visit.\n 7. Subject states that they are a habitual consumer of a morning meal.\n\nExclusion Criteria:\n\n* Subjects will be excluded from the study if they meet any of the following criteria:\n\n 1. Use of exogenous insulin or GLP-1 agonists for glucose control.\n 2. Diagnosis of Type 1 diabetes.\n 3. History of diabetic ketoacidosis.\n 4. Current infection (requiring medication or hospitalization), has received corticosteroid treatment in the last 3 months, or has had surgery or received antibiotics in the last 3 weeks.\n 5. Active malignancy.\n 6. Significant cardiovascular event \\< 12 weeks prior to study entry.\n 7. End stage organ failure or status post organ transplant.\n 8. Active metabolic, hepatic, or gastrointestinal disease.\n 9. Chronic, contagious, infectious disease.\n 10. Currently taking herbals, dietary supplements, or medications (other than antihyperglycemic medications) that could profoundly affect blood glucose.\n 11. History of fainting or other adverse reactions in response to blood collection.\n 12. Clotting or bleeding disorders.\n 13. Allergy or intolerance to study product ingredient.'}, 'identificationModule': {'nctId': 'NCT01850134', 'briefTitle': 'Evaluation of a Nutritional Supplement for People With Type 2 Diabetes.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Nutrition'}, 'officialTitle': 'Evaluation of a Nutritional Supplement for People With Type 2 Diabetes (T2DM).', 'orgStudyIdInfo': {'id': 'BL18'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control Study Product', 'description': '1 serving of control beverage.', 'interventionNames': ['Other: Control Study Product']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental Study Product', 'description': '1 serving of a nutritional supplement for people with diabetes.', 'interventionNames': ['Other: Experimental Study Product']}], 'interventions': [{'name': 'Experimental Study Product', 'type': 'OTHER', 'otherNames': ['Oral nutritional supplement for people with Diabetes.'], 'armGroupLabels': ['Experimental Study Product']}, {'name': 'Control Study Product', 'type': 'OTHER', 'otherNames': ['Water beverage.'], 'armGroupLabels': ['Control Study Product']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60101', 'city': 'Addison', 'state': 'Illinois', 'country': 'United States', 'facility': 'Biofortis Clinical Research', 'geoPoint': {'lat': 41.9317, 'lon': -87.98896}}, {'zip': '45249', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Radiant Research', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], 'overallOfficials': [{'name': 'Amy Devitt-Maicher, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Abbott Nutrition'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Nutrition', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}