Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2025-12-25 @ 8:49 PM
Study NCT ID:
NCT00797069
Status:
COMPLETED
Last Update Posted:
2010-07-30
First Post:
2008-11-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Nutritional Products for People 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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-03', 'completionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-07-29', 'studyFirstSubmitDate': '2008-11-23', 'studyFirstSubmitQcDate': '2008-11-24', 'lastUpdatePostDateStruct': {'date': '2010-07-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-11-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To compare the postprandial glycemic response of patients with type 2 diabetes consuming single servings of a standard liquid nutrition product and two diabetes-specific liquid nutrition products.', 'timeFrame': 'Three crossover periods'}], 'secondaryOutcomes': [{'measure': 'To compare the postprandial insulinemic response of patients with type 2 diabetes consuming single servings of a standard liquid nutrition product and two diabetes-specific liquid nutrition products.', 'timeFrame': 'Three crossover periods'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': 'Compare the glycemic and insulinemic responses of a standard nutritional product with two diabetes-specific nutritional products in patients with type 2 diabetes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Subject states that he/she has type 2 diabetes (as evidenced by use of oral hypoglycemic medication for at least two months).\n2. Subject is between 18 and 75 years of age, inclusive.\n3. Subject is a male or a non-pregnant, non-lactating female, at least 6 weeks postpartum prior to screening visit.\n4. If female is of childbearing potential, is practicing a method of birth control.\n5. Subject's BMI is \\> 18.5 kg/m2 and \\< 35 kg/m2.\n6. If on a chronic medication such as anti-hypertensive, lipid-lowering, thyroid medication or hormone therapy, subject has been on constant dosage for at least two months prior to screening visit.\n\nExclusion Criteria:\n\n1. Subject uses exogenous insulin for glucose control.\n2. Subject states that he/she has type 1 diabetes.\n3. Subject states that he/she has a history of diabetic ketoacidosis.\n4. Subject takes an alpha-glucosidase inhibitor.\n5. Subject states that he/she has a current infection ; has had inpatient surgery, or corticosteroid treatment in the last 3 months or antibiotics in the last 3 weeks prior to screening visit.\n6. Subject states that he/she has an active malignancy (excluding the following dermal malignancies: basal cell carcinoma, squamous cell carcinoma, carcinoma in-situ of the cervix).\n7. Subject states that he/she has had a significant cardiovascular event ≤ six months prior to screening visit; or stated history of congestive heart failure.\n8. Subject states that he/she has end stage organ failure or is status post organ transplant.\n9. Subject states that he/she has a history of renal disease.\n10. Subject states that he/she has current hepatic disease.\n11. Subject states that he/she has a history of severe gastroparesis.\n12. Subject states that he/she has a chronic, contagious, infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV.\n13. Subject has taken/is currently taking any herbals, dietary supplements, or medications, other than oral hypoglycemic medications, during the past four weeks prior to screening visit that could profoundly affect blood glucose.\n14. Subject states that he/she has clotting or bleeding disorders.\n15. Subject is known to be allergic or intolerant to any ingredient found in the study products."}, 'identificationModule': {'nctId': 'NCT00797069', 'briefTitle': 'Comparison of Nutritional Products for People With Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Nutrition'}, 'officialTitle': 'Comparison of Nutritional Products for People With Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'BK20'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'standard nutritional product', 'description': 'Standard nutritional product not specific for diabetes', 'interventionNames': ['Other: standard nutritional product (medical food)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'diabetes specific product', 'description': 'Diabetes specific nutritional product', 'interventionNames': ['Other: nutritional product for diabetes (medical food)']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental diabetes specific product', 'description': 'Diabetes specific experimental nutritional product', 'interventionNames': ['Other: diabetes specific experimental nutritional product (medical food)']}], 'interventions': [{'name': 'standard nutritional product (medical food)', 'type': 'OTHER', 'description': 'once during crossover', 'armGroupLabels': ['standard nutritional product']}, {'name': 'nutritional product for diabetes (medical food)', 'type': 'OTHER', 'description': 'once during crossover', 'armGroupLabels': ['diabetes specific product']}, {'name': 'diabetes specific experimental nutritional product (medical food)', 'type': 'OTHER', 'description': 'once during crossover', 'armGroupLabels': ['Experimental diabetes specific product']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28040', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Clinico San Carlos', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '29010', 'city': 'Málaga', 'country': 'Spain', 'facility': 'Hospital Universitario Virgen de la Victoria', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'zip': '50009', 'city': 'Zaragoza', 'country': 'Spain', 'facility': 'Hospital Universitario Miguel Servet', 'geoPoint': {'lat': 41.65606, 'lon': -0.87734}}], 'overallOfficials': [{'name': 'Jennifer Williams, MS', 'role': 'STUDY_CHAIR', 'affiliation': 'Abbott Nutrition'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Nutrition', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Bobbie Swearengin, Director Clinical Research', 'oldOrganization': 'Abbott Nutrition'}}}}