Ignite Creation Date:
2025-12-24 @ 4:34 PM
Ignite Modification Date:
2026-01-24 @ 10:27 PM
Study NCT ID:
NCT02898766
Status:
COMPLETED
Last Update Posted:
2016-10-11
First Post:
2016-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Glycemic Response to Two Enteral Formulas in Persons With Type 2 Diabetes Mellitus
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-10', 'studyFirstSubmitDate': '2016-09-08', 'studyFirstSubmitQcDate': '2016-09-08', 'lastUpdatePostDateStruct': {'date': '2016-10-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-09-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under the blood glucose curve (AUC 0-240)', 'timeFrame': 'Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes'}], 'secondaryOutcomes': [{'measure': 'Area under the insulin curves (AUC 0-240)', 'timeFrame': 'Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes'}, {'measure': 'Insulinogenic index (Ins30/(Glu30))', 'timeFrame': 'Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes'}, {'measure': 'AUC (0-30min) for insulin', 'timeFrame': 'Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes']}, 'descriptionModule': {'briefSummary': 'This will be a randomized, cross-over design. Subjects will be randomized to one of two interventions on two separate study days, 1 week apart.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 20-75 yrs\n* Type 2 diabetes controlled with diet or diet and oral agent, with the exception of sulfonylureas such as glimepiride (Amaryl), glipizide, Glucotrol/GlucotrolXL) and glyburide (DiaBeta, Micronase, (Glynase Prestabs); meglitinides such as reaglinide (Prandin) and nateglinide (Starlix); and alphaglucosidase inhibitors such as acarbose (Precose) and miglitol (Glyset)\n* Hemoglobin A1C less than 9.0%\n* Fasting blood glucose less than 180 mg\n\nExclusion Criteria:\n\n* Abnormal thyroid function\n* Creatinine \\>2.0 mg/dL\n* Potassium \\<3.5 mEq/L\n* Gastrointestinal disease: ulcer, gastritis, diarrhea, gastroparesis, vomiting\n* History of bypass surgery, midface trauma, esophageal varices, coagulation abnormalities\n* Patients currently on any anti-coagulant medication\n* Currently unstable diabetes or under treatment for cancer, heart disease, renal disease\n* Unable to give informed consent or follow instructions\n* Current insulin therapy or insulin therapy within the past month\n* Patient who are pregnant\n* Allergies to milk, fish oil or any component of the test product\n* Patient who in the Investigators assessment cannot be expected to comply with treatment\n* Currently participating or having participated in another clinical trial.'}, 'identificationModule': {'nctId': 'NCT02898766', 'briefTitle': 'Glycemic Response to Two Enteral Formulas in Persons With Type 2 Diabetes Mellitus', 'organization': {'class': 'INDUSTRY', 'fullName': 'Société des Produits Nestlé (SPN)'}, 'officialTitle': 'Plasma Glucose and Insulin Response to Two Enteral Formulas in Persons With Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': '16.17.CLI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Enteral Nutrition Formula 1', 'description': 'Enteral Nutrition Formula', 'interventionNames': ['Other: Enteral Nutrition Formula']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Enteral Nutrition Formula 2', 'description': 'Enteral Nutrition Formula', 'interventionNames': ['Other: Enteral Nutrition Formula']}], 'interventions': [{'name': 'Enteral Nutrition Formula', 'type': 'OTHER', 'armGroupLabels': ['Enteral Nutrition Formula 1', 'Enteral Nutrition Formula 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92780', 'city': 'Tustin', 'state': 'California', 'country': 'United States', 'facility': 'Orange County Research Center', 'geoPoint': {'lat': 33.74585, 'lon': -117.82617}}], 'overallOfficials': [{'name': 'Joel Neutel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Orange County Research Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Société des Produits Nestlé (SPN)', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}