Ignite Creation Date:
2025-12-24 @ 7:06 PM
Ignite Modification Date:
2025-12-25 @ 4:40 PM
Study NCT ID:
NCT04413357
Status:
COMPLETED
Last Update Posted:
2024-10-21
First Post:
2020-05-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Glycemic Response in Persons 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C084245', 'term': 'HLA-DM antigens'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Site pharmacy will not be blinded to product assignment, study staff and participants will be blinded to product assignment. Product will be provided in unlabeled cups.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'This will be a randomized crossover design. The subjects will be randomized to one of three interventions on three separate study days, one week apart.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2020-08-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-18', 'studyFirstSubmitDate': '2020-05-29', 'studyFirstSubmitQcDate': '2020-05-29', 'lastUpdatePostDateStruct': {'date': '2024-10-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under the blood glucose curve', 'timeFrame': 'Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes', 'description': 'Area under the blood glucose curve (AUC 0-240 minutes)'}], 'secondaryOutcomes': [{'measure': 'Area under the insulin curves', 'timeFrame': 'Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes', 'description': 'Area under the insulin curves (AUC 0-240)'}, {'measure': 'Insulinogenic index', 'timeFrame': 'Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes', 'description': 'Insulinogenic index \\[Change in Ins30/Change in Glu30\\]'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': 'This will be a randomized crossover design with nutrition supplement interventions.', 'detailedDescription': 'This will be a randomized crossover design with three oral nutrition supplement interventions. The subjects will be randomized to one of three interventions on three separate study days, one 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 years\n* Type 2 diabetes controlled with diet or diet and metformin (Glucophage)\n* Hemoglobin A1C less than 9.0%\n* Fasting blood glucose less than 180 mg\n* Hematocrit levels within normal limits\n* Having obtained his/her informed consent\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* Patient 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\n* Patients with anemia'}, 'identificationModule': {'nctId': 'NCT04413357', 'briefTitle': 'Glycemic Response in Persons with Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Société des Produits Nestlé (SPN)'}, 'officialTitle': 'Plasma Glucose and Insulin Response in Persons with Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': '19.01.US.HCN'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Balanced Nutritional Drink', 'description': 'The study interventions contain protein, carbohydrate and fat and are intended for use as Supplemental Nutrition.', 'interventionNames': ['Other: Balanced Nutritional Drink']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Balanced Nutritional Drink - DMA', 'description': 'The study interventions contain protein, carbohydrate and fat and are intended for use as retail Supplemental Nutrition for people living with diabetes.', 'interventionNames': ['Other: Diabetes Specific, Balanced Nutritional Drink (DMA)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Balanced Nutritional Drink - DMB', 'description': 'The study interventions contain protein, carbohydrate and fat and are intended for use as Supplemental Nutrition for people living with diabetes.', 'interventionNames': ['Other: Diabetes Specific, Balanced Nutritional Drink DMB']}], 'interventions': [{'name': 'Balanced Nutritional Drink', 'type': 'OTHER', 'description': 'Drink 1 cup of liquid nutrition product that contains protein, carbohydrate and fat intended for use as Supplemental Nutrition.', 'armGroupLabels': ['Balanced Nutritional Drink']}, {'name': 'Diabetes Specific, Balanced Nutritional Drink (DMA)', 'type': 'OTHER', 'description': 'Drink 1 cup of liquid nutrition product that contains protein, carbohydrate and fat, designed for people living with diabetes and intended for use as Supplemental Nutrition available in retail setting.', 'armGroupLabels': ['Balanced Nutritional Drink - DMA']}, {'name': 'Diabetes Specific, Balanced Nutritional Drink DMB', 'type': 'OTHER', 'description': 'Drink 1 cup of liquid nutrition product that contains protein, carbohydrate and fat, designed for people living with diabetes and intended for use as Supplemental Nutrition.', 'armGroupLabels': ['Balanced Nutritional Drink - DMB']}]}, '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': 'Krysmaru Araujo Torres, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Nestle Health Science'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Société des Produits Nestlé (SPN)', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}