Ignite Creation Date:
2025-12-26 @ 11:47 AM
Ignite Modification Date:
2026-01-11 @ 10:10 PM
Study NCT ID:
NCT02856516
Status:
COMPLETED
Last Update Posted:
2016-10-11
First Post:
2016-08-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Glycemic Response to Three Oral Nutrition Supplements 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': '2016-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-10', 'studyFirstSubmitDate': '2016-08-02', 'studyFirstSubmitQcDate': '2016-08-02', 'lastUpdatePostDateStruct': {'date': '2016-10-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-08-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', '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 three interventions on three separate study days, 1 week apart.', 'detailedDescription': 'Following consent, subjects will be randomized to one of three arms. After an overnight fast an intravenous line will be placed for blood withdrawal. The subject will then consume the randomly assigned intervention. Blood samples for glucose and insulin levels will be drawn at specified intervals after the product has been consumed.'}, '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/Glucotrol XL) 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* 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* Patients who are pregnant\n* Allergies to milk, soy 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': 'NCT02856516', 'briefTitle': 'Glycemic Response to Three Oral Nutrition Supplements in Persons With Type 2 Diabetes Mellitus', 'organization': {'class': 'INDUSTRY', 'fullName': 'Société des Produits Nestlé (SPN)'}, 'officialTitle': 'Plasma Glucose and Insulin Response to Three Oral Nutrition Supplements in Persons With Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': '15.11.US.HCN'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Boost Glucose Control (A)', 'description': 'Nutritional beverage (Oral Nutrition Supplement) designed for oral consumption in people with Diabetes.', 'interventionNames': ['Other: Boost Glucose Control (A)']}, {'type': 'EXPERIMENTAL', 'label': 'Boost Glucose Control (B)', 'description': 'Nutritional beverage (Oral Nutrition Supplement) designed for oral consumption in people with Diabetes.', 'interventionNames': ['Other: Boost Glucose Control (B)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Boost Original', 'description': 'Nutritional beverage (Oral Nutrition Supplement) designed for oral consumption.', 'interventionNames': ['Other: Boost Original']}], 'interventions': [{'name': 'Boost Glucose Control (A)', 'type': 'OTHER', 'description': 'Oral nutrition supplement', 'armGroupLabels': ['Boost Glucose Control (A)']}, {'name': 'Boost Glucose Control (B)', 'type': 'OTHER', 'description': 'Oral nutrition supplement', 'armGroupLabels': ['Boost Glucose Control (B)']}, {'name': 'Boost Original', 'type': 'OTHER', 'description': 'Oral nutrition supplement', 'armGroupLabels': ['Boost Original']}]}, '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'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data will be presented in a peer reviewed manuscript'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Société des Produits Nestlé (SPN)', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}