Ignite Creation Date:
2025-12-25 @ 12:59 AM
Ignite Modification Date:
2025-12-25 @ 11:13 PM
Study NCT ID:
NCT05913193
Status:
COMPLETED
Last Update Posted:
2025-08-28
First Post:
2023-05-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Oral Nutritional Supplement in Type 2 Diabetes Subjects With or at Risk of Malnutrition
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019587', 'term': 'Dietary Supplements'}], 'ancestors': [{'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 231}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-12-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-06-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-27', 'studyFirstSubmitDate': '2023-05-30', 'studyFirstSubmitQcDate': '2023-06-21', 'lastUpdatePostDateStruct': {'date': '2025-08-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-06-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Study Product Compliance', 'timeFrame': 'Baseline to Day 90', 'description': 'Participant completed daily record of nutritional support program'}, {'measure': 'Participant Satisfaction Survey', 'timeFrame': 'Day 90 or Early Exit', 'description': 'Participant assessed 4 questions related to the nutritional support program scored from 1 to 10 where higher number is more favorable'}, {'measure': 'Health Care Professional Satisfaction Survey', 'timeFrame': 'Day 90 or Early Exit', 'description': "Health Care Professional assessed 8 questions related to each Participant's study experience"}, {'measure': 'Medication Usage', 'timeFrame': 'Baseline to Day 60 to Day 90', 'description': 'Medications prescribed for glucose or appetite control'}, {'measure': 'Body Mass Index', 'timeFrame': 'Baseline to Day 90', 'description': 'As calculated from Height and Weight'}, {'measure': 'Calf Circumference', 'timeFrame': 'Baseline to Day 90', 'description': 'Measured in cm'}], 'primaryOutcomes': [{'measure': 'Nutritional status risk by MUST', 'timeFrame': 'Baseline to Day 90', 'description': 'Change in status as assessed by the Malnutrition Universal Screening Tool (MUST); Higher score indicates greater risk of malnutrition'}], 'secondaryOutcomes': [{'measure': 'Blood Glycemic Measurement', 'timeFrame': 'Baseline to Day 90', 'description': 'Change in glycemic control markers where lower levels are associated with improved control'}, {'measure': 'Handgrip Strength', 'timeFrame': 'Baseline to Day 90', 'description': 'Change in handgrip as measured in kg'}, {'measure': 'Chair Stand Test', 'timeFrame': 'Baseline to Day 90', 'description': 'Change in test score where higher number of times completed is more favorable'}, {'measure': 'Body Composition', 'timeFrame': 'Baseline to Day 90', 'description': 'Change in body composition where increased fat free mass is more favorable'}, {'measure': 'EQ-5D Quality of Life', 'timeFrame': 'Baseline to Day 90', 'description': 'Participant assessed 5 Domains; Each Domain scored from 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.'}, {'measure': 'Diabetes Distress Scale', 'timeFrame': 'Baseline to Day 90', 'description': 'Participant assessed 29 questions rated from 1 to 5 where higher number if less favorable'}, {'measure': 'Subjective Global Assessment', 'timeFrame': 'Baseline to Day 90', 'description': 'Healthcare Professional completed assessment of 4 components resulting in score where A = Well Nourished, B = Moderately Malnourished, and C = Severely Malnourished'}, {'measure': 'Global Leadership Initiative on Malnutrition (GLIM) Diagnosis of Malnutrition', 'timeFrame': 'Baseline to Day 90', 'description': 'Change in GLIM as calculated from MUST malnutrition risk and Phenotypic and Etiological Criteria'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Malnutrition', 'Diabetes']}, 'descriptionModule': {'briefSummary': 'This multicenter, prospective study will evaluate the use of a nutritional support program including an oral diabetes-specific nutritional supplement consumed twice a day on the nutritional status of patients with T2D with or at risk of malnutrition.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Adult participants with type 2 diabetes receiving an oral nutritional supplement as standard of care will be recruited from the investigator's community population.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 diabetes on treatment with one or more oral antidiabetics/insulin and constant dose for at least 2 months\n* Has HbA1c \\< 9.0% based on recent (30 days prior to Baseline visit) laboratory value or analysis of blood sample obtained at Baseline Visit\n* Adult population with age ≥30 years\n* Willing to follow the protocol as described\n* Voluntarily signed and dated an informed consent form (ICF), approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to any participation in the study to allow their data to be collected\n* Subject is under the care of a health care professional for malnutrition, or is at risk for malnutrition (MUST≥1), and has recently (within the last 7 days prior to participating in this study) been prescribed study oral nutritional supplement (2 servings/day) by their health care professional\n\nExclusion Criteria:\n\n* History of T2D longer than 30 years\n* History of diabetic ketoacidosis and or hyperosmolar hyperglycemic state (HHS)\n* If on thyroid medication or hormone replacement therapy, has not been on a constant dosage for at least 2 months prior to Baseline Visit\n* History of metabolic/endocrine (other than diabetes), hepatic (AST/ALT 3 times the upper normal limit), or significant renal disease (GFR \\< 60 ml/min/1.73m2)\n* History of heart failure (\\> class II)\n* Follows a non-typical eating pattern, such as very low carbohydrate diet (e.g., Atkins diet, ketogenic diet, high protein diet), strict vegetarianism (e.g., no meat, dairy, eggs).\n* Is pregnant as confirmed via urine pregnancy test, attempting to conceive or not willing and able to practice birth control during the study duration\n* Has current infection (requiring medication or which might be expected to require hospitalization); has had inpatient surgery, or corticosteroid treatment (excluding topical creams) in the last 3 months or antibiotics in the last 3 weeks prior to Baseline Visit.\n* Has an active malignancy\n* Known to be allergic or intolerant to any ingredient found in the study products\n* Taking any medications, herbals, or dietary supplements, other than allowed medications, during the past 4 weeks that could profoundly affect (in the opinion of the PI or study physician) blood glucose or appetite modifying medications (examples include orlistat, contrive, incretins, cannabis).\n* Has known dementia, eating disorders, history of significant neurological or psychiatric disorder, or any other psychological condition that may interfere with study product consumption AND does not have a caregiver who can assist them with adherence to the study protocol\n* Participant in a concomitant AN trial or trial of a nonregistered drug (or is within the 30 days follow-up period for such a trial) or that otherwise conflicts with this study unless otherwise approved by Abbott Nutrition.\n* Patient is receiving any other oral supplement with HMB for nutritional management in the last 7 days'}, 'identificationModule': {'nctId': 'NCT05913193', 'briefTitle': 'Oral Nutritional Supplement in Type 2 Diabetes Subjects With or at Risk of Malnutrition', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Nutrition'}, 'officialTitle': 'High Calorie and High Protein Diabetes-specific Oral Nutritional Supplement in Type 2 Diabetes Subjects With or at Risk of Malnutrition in Real-life Setting: A Post-marketing Observational Study (PMO)', 'orgStudyIdInfo': {'id': 'DA31'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Oral Nutritional Supplement (ONS) Group', 'description': '2 servings per day as per standard of care during the study period', 'interventionNames': ['Other: Oral Nutritional Supplement (ONS)']}], 'interventions': [{'name': 'Oral Nutritional Supplement (ONS)', 'type': 'OTHER', 'description': 'Diabetes specific oral nutritional supplement', 'armGroupLabels': ['Oral Nutritional Supplement (ONS) Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14004', 'city': 'Córdoba', 'state': 'Cordoba', 'country': 'Spain', 'facility': 'Hospital Reina Sophia', 'geoPoint': {'lat': 37.89155, 'lon': -4.77275}}, {'zip': '29010', 'city': 'Málaga', 'state': 'Malaga', 'country': 'Spain', 'facility': 'Hospital Especialidades Virgen De La Victoria', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'zip': '29010', 'city': 'Málaga', 'state': 'Malaga', 'country': 'Spain', 'facility': 'Hospital Regional Malaga', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'zip': '48013', 'city': 'Bilbao', 'country': 'Spain', 'facility': 'Hospital Universitario Basurto', 'geoPoint': {'lat': 43.26271, 'lon': -2.92528}}, {'zip': '11009', 'city': 'Cadiz', 'country': 'Spain', 'facility': 'Hospital Uni. Puerta Del Mar', 'geoPoint': {'lat': 36.52672, 'lon': -6.2891}}, {'zip': '18014', 'city': 'Granda', 'country': 'Spain', 'facility': 'Hospital Virgen De Las Nieves', 'geoPoint': {'lat': 43.50128, 'lon': -5.65567}}, {'zip': '21005', 'city': 'Huelva', 'country': 'Spain', 'facility': 'Hospital Juhn Romon Jimenez', 'geoPoint': {'lat': 37.26638, 'lon': -6.94004}}, {'zip': '23007', 'city': 'Jaén', 'country': 'Spain', 'facility': 'Hospital Universitario Jaen', 'geoPoint': {'lat': 37.76922, 'lon': -3.79028}}, {'zip': '35016', 'city': 'Las Palmas de Gran Canaria', 'country': 'Spain', 'facility': 'Complejo Hospitalario Universitario Insular-Materno infantil', 'geoPoint': {'lat': 28.10178, 'lon': -15.41573}}, {'zip': '28041', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario 12 de Octubre', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28046', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital La Paz', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28050', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Clinico San Carlos', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Ramon y Cajal', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '41013', 'city': 'Seville', 'country': 'Spain', 'facility': 'Hospital Virgen Del Rocio', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': '46010', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Hospital Clinico Valencia', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '46026', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Hospital La Fe', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '50009', 'city': 'Zaragoza', 'country': 'Spain', 'facility': 'Hospital Miguel Servet', 'geoPoint': {'lat': 41.65606, 'lon': -0.87734}}], 'overallOfficials': [{'name': 'German Guzman, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Abbott'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Nutrition', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}