Ignite Creation Date:
2025-12-25 @ 4:10 AM
Ignite Modification Date:
2025-12-26 @ 3:07 AM
Study NCT ID:
NCT03766620
Status:
COMPLETED
Last Update Posted:
2020-07-24
First Post:
2018-12-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Tube Feeding Study in Malnourished Population With Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 49}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-23', 'studyFirstSubmitDate': '2018-12-05', 'studyFirstSubmitQcDate': '2018-12-05', 'lastUpdatePostDateStruct': {'date': '2020-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Functionality', 'timeFrame': 'Baseline to Study Exit Week 12', 'description': 'Barthel Index of Activities of Daily Living; Subject completed assessment of 10 functions; Sum of scores range from 0-20 scaled in positive direction'}, {'measure': 'Physician Product Satisfaction', 'timeFrame': 'Baseline to Study Exit Week 12', 'description': 'Physician Completed Questionnaire; 3 to 5 category responses scaled in negative direction'}], 'primaryOutcomes': [{'measure': 'Body Weight Change', 'timeFrame': 'Baseline to Study Exit Week 12', 'description': 'Measured in Kg'}], 'secondaryOutcomes': [{'measure': 'Malnutrition Universal Screening Tool (MUST)', 'timeFrame': 'Baseline to Study Exit Week 12', 'description': 'HCP completed screening tool'}, {'measure': 'Subjective Global Assessment (SGA)', 'timeFrame': 'Baseline to Study Exit Week 12', 'description': 'HCP completed nutrition assessment'}, {'measure': 'Quality of life (EuroQol EQ-5D-5L)', 'timeFrame': 'Baseline to Study Exit Week 12', 'description': 'Subject rated health state of 5 dimensions. Each dimension has 5-levels scaled in negative direction resulting in an overall 5-digit number describing the health state; EQ VAS Score 0-100 points scaled in positive direction'}, {'measure': 'Glucose control', 'timeFrame': 'Baseline to Study Exit Week 12', 'description': 'HbA1c levels'}, {'measure': 'Body Mass Index', 'timeFrame': 'Baseline to Study Exit Week 12', 'description': 'BMI calculated Weight (kg)/Height (m)2'}, {'measure': 'Product Compliance', 'timeFrame': 'Baseline to Study Exit Week 12', 'description': 'Product consumption diary'}, {'measure': 'Albumin Levels', 'timeFrame': 'Baseline to Study Exit Week 12', 'description': 'Nutrition status parameter collected per standard of care'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Malnutrition; Diabetes']}, 'descriptionModule': {'briefSummary': 'This is a prospective, non-interventional, observational study. Malnourished subjects with diabetes, who are receiving a high calorie, high protein tube feeding with slow release carbohydrates and MUFA by their health care professional (HCP) per standard of care will be enrolled into the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects, men and women who meet all enrollment criteria, will be enrolled from study centers in Spain.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Voluntarily signed and dated an informed consent form, approved by an Independent Ethics Committee, prior to any participation in the study\n* Considered malnourished, or at risk for malnutrition\n* Diagnosed with diabetes mellitus type 1 or 2 and treated with oral hypoglycemic medications and/or exogenous insulin\n* Conforms to the requirements set forth on the study product label\n* Under the care of a health care professional for malnutrition and has recently been prescribed tube feeding as a sole-source of nutrition by their health care professional\n* Free living, residing in a nursing home or admitted to the hospital and has anticipated length of hospital stay \\> 3 days and \\< 12 days\n\nExclusion Criteria:\n\n* Severe dementia or delirium, eating disorder, history of significant neurological or psychiatric disorder, alcoholism, substance abuse or other conditions that may interfere with study product consumption or compliance with study protocol procedures\n* Cannot safely consume the study product, or known to be allergic or intolerant to any ingredient found in the study product\n* Renal or liver failure\n* Participates in another study that has not been approved as a concomitant study by AN'}, 'identificationModule': {'nctId': 'NCT03766620', 'briefTitle': 'A Tube Feeding Study in Malnourished Population With Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Nutrition'}, 'officialTitle': 'A Prospective, Observational Study, of a High Calorie, High Protein Tube Feeding With Slow Release Carbohydrates and Monounsaturated Fatty Acids (MUFA), in a Malnourished Population With Diabetes', 'orgStudyIdInfo': {'id': 'DA14'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Tube Fed Participants', 'description': 'Individuals with diabetes and malnutrition receiving tube feed as sole source nutrition.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '26006', 'city': 'Logroño', 'state': 'La Rioja', 'country': 'Spain', 'facility': 'Hospital San Pedro', 'geoPoint': {'lat': 42.46615, 'lon': -2.45115}}, {'zip': '29603', 'city': 'Marbella', 'state': 'Málaga', 'country': 'Spain', 'facility': 'Hospital Costa del Sol 3095', 'geoPoint': {'lat': 36.51543, 'lon': -4.88583}}, {'zip': '29603', 'city': 'Marbella', 'state': 'Málaga', 'country': 'Spain', 'facility': 'Hospital Costa del Sol 3178', 'geoPoint': {'lat': 36.51543, 'lon': -4.88583}}, {'zip': '28046', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario La Paz', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28047', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Gomez-Ulla', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '29007', 'city': 'Málaga', 'country': 'Spain', 'facility': 'Centro Médico San juan de la Cruz', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'zip': '46014', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Hospital General Universitario de Valencia', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '47003', 'city': 'Valladolid', 'country': 'Spain', 'facility': 'Hospital Clínico Universitario de Valladolid', 'geoPoint': {'lat': 41.65541, 'lon': -4.72353}}], 'overallOfficials': [{'name': 'Maria Camprubi Robles, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Abbott'}, {'name': 'Angela M Palmero, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital San Pedro de La Rioja'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Nutrition', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}