Ignite Creation Date:
2025-12-24 @ 2:02 PM
Ignite Modification Date:
2025-12-27 @ 9:15 PM
Study NCT ID:
NCT01241695
Status:
COMPLETED
Last Update Posted:
2012-07-02
First Post:
2010-11-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety, Acceptability and Efficacy of a Long-term Intervention With a Diabetes-specific Low-carbohydrate, High-mono-unsaturated Fatty Acid Containing Oral Nutritional Supplement on Glycaemic Control in Type 2 Diabetic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019587', 'term': 'Dietary Supplements'}, {'id': 'D005502', 'term': 'Food'}], 'ancestors': [{'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-11', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-29', 'studyFirstSubmitDate': '2010-11-10', 'studyFirstSubmitQcDate': '2010-11-15', 'lastUpdatePostDateStruct': {'date': '2012-07-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-11-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'postprandial blood glucose (iAUC) (0-240 min)', 'timeFrame': 'day 1'}, {'measure': 'postprandial blood glucose (iAUC) (0-240 min)', 'timeFrame': 'day 42'}, {'measure': 'postprandial blood glucose (iAUC) (0-240 min)', 'timeFrame': 'day 84'}], 'secondaryOutcomes': [{'measure': 'postprandial peak blood glucose (0-240 min)', 'timeFrame': 'day 1, day 42, day 84'}, {'measure': 'postprandial triglycerides (0-240 min)', 'timeFrame': 'day 1, day 42, day 84'}, {'measure': 'total cholesterol, HDL-cholesterol, LDL-cholesterol', 'timeFrame': 'day 1, day 42, day 84'}, {'measure': 'total protein, albumin, prealbumin', 'timeFrame': 'day 1, day 42, day 84'}, {'measure': 'HbA1c, HOMA-IR index', 'timeFrame': 'day 1, day 42, day 84'}, {'measure': 'c-peptide', 'timeFrame': 'day 1, day 84'}, {'measure': 'gastrointestinal tolerance', 'timeFrame': 'week 1, week 6, week 12'}, {'measure': 'palatability / taste test', 'timeFrame': 'week 1, week 6, week 12', 'description': 'by means of a sensorial questionnaire the patients will evaluate the overall liking, appearance, smell, taste, mouth feel et cetera of the study nutrition.'}, {'measure': 'daily compliance', 'timeFrame': 'day 1-84', 'description': 'in a daily compliance questionnaire the patients record the amount of oral nutritional supplements consumed.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Oral nutritional supplement, diabetes mellitus type 2, glycaemic control', 'Oral nutritional supplement (Food for special medical purposes)'], 'conditions': ['Diabetes']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine the safety, acceptability and the efficacy of a 12-week intervention with a diabetes-specific oral nutritional supplement on glycaemic control in type 2 diabetic patients with or at risk of malnutrition'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosis of type 2 diabetes according to the WHO diagnostic criteria for more than 6 months: Fasting plasma glucose (FPG) ≥ 126 mg/dl (7.0 mmol/l) or 2-h plasma glucose ≥ 200 mg/dl (11.1 mmol/l) during an OGTT (oral glucose tolerance test);\n* HbA1c between 6.5-8.5 % (confirmed in the previous 3 months),\n* capable of using oral nutritional supplementation,\n* on stable and controlled anti-diabetic regime for at least 1 months,\n* use of metformin and/or sulphonylureas as oral anti-diabetic medication,\n* in need of nutritional support because of ≥5% involuntary weight loss in the last 3 months, ≥10% involuntary weight loss in the last 6 months, inadequate nutritional intake causing failure to meet nutritional requirements or at risk of developing malnutrition\n\nExclusion Criteria:\n\n* diabetes type 1,\n* participation in a clinical trial with an investigational product or regular use of disease-specific oral nutritional supplements within 4 weeks prior to study start\n* patients requiring a fibre free diet,\n* enteral tube feed or parenteral nutrition,\n* concomitant therapy with systemic glucocorticoids, insulins or anti-diabetic medication other than metformin and sulphonylureas,\n* known or suspected intolerance or allergy to any component of the investigational product(s),\n* any acute gastrointestinal disease within 2 weeks prior to study entry,\n* gastrectomy, gastroparesis or other gastric emptying abnormalities,\n* acute sever heart failure (NYHA class 4), liver insufficiency / failure (male: ALAT \\> 150 U/l; female: ALAT \\> 120 U/l) or renal failure requiring dialysis,\n* cancer cachexia,\n* galactosaemia, fructosaemia,\n* suspicion of drug abuse, abuse of/addiction to alcohol,\n* pregnant or breast feeding women, or fertile women refusing to use contraceptives,\n* patients with untreated major psychiatric disorder,\n* known HIV positive (safety reasons),\n* patient unable to co-operate adequately'}, 'identificationModule': {'nctId': 'NCT01241695', 'briefTitle': 'Safety, Acceptability and Efficacy of a Long-term Intervention With a Diabetes-specific Low-carbohydrate, High-mono-unsaturated Fatty Acid Containing Oral Nutritional Supplement on Glycaemic Control in Type 2 Diabetic Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Fresenius Kabi'}, 'orgStudyIdInfo': {'id': 'GCOS-002-CFS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test', 'description': 'Diben DRINK (200 ml) / a diabetes-specific oral nutritional supplement', 'interventionNames': ['Dietary Supplement: Oral nutritional supplement, food for special medical purposes']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Fresubin(R) energy fibre DRINK / an isoenergetic standard oral nutritional supplement', 'interventionNames': ['Dietary Supplement: Oral nutritional supplement, food for special medical purposes']}], 'interventions': [{'name': 'Oral nutritional supplement, food for special medical purposes', 'type': 'DIETARY_SUPPLEMENT', 'description': '2 servings of 200 ml per day, treatment period: 12 weeks', 'armGroupLabels': ['Test']}, {'name': 'Oral nutritional supplement, food for special medical purposes', 'type': 'DIETARY_SUPPLEMENT', 'description': '2 servings of 200 ml per day, treatment period: 12 weeks', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78333', 'city': 'Stockach', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'Medical Practice', 'geoPoint': {'lat': 47.85105, 'lon': 9.0091}}], 'overallOfficials': [{'name': 'Peter Mayr, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical Practice, 78333 Stockach'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fresenius Kabi', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}