Ignite Creation Date:
2025-12-24 @ 7:17 PM
Ignite Modification Date:
2026-02-22 @ 2:45 PM
Study NCT ID:
NCT01474603
Status:
COMPLETED
Last Update Posted:
2016-03-16
First Post:
2011-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of n-3 Polyunsaturated Fatty Acids in a Protein-enriched Diet With Low GI in Type 2 Diabetes Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015525', 'term': 'Fatty Acids, Omega-3'}], 'ancestors': [{'id': 'D004042', 'term': 'Dietary Fats, Unsaturated'}, {'id': 'D004041', 'term': 'Dietary Fats'}, {'id': 'D005223', 'term': 'Fats'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D005395', 'term': 'Fish Oils'}, {'id': 'D009821', 'term': 'Oils'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'serum and plasma samples for biochemical analyses'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-14', 'studyFirstSubmitDate': '2011-11-15', 'studyFirstSubmitQcDate': '2011-11-17', 'lastUpdatePostDateStruct': {'date': '2016-03-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-11-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HbA1c change from baseline (type 2 diabetes patients)', 'timeFrame': '3 months'}, {'measure': 'body weight change from baseline (non-diabetic patients)', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'change from baseline of inflammatory and metabolic parameters', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['observational study'], 'conditions': ['Overweight', 'Obese', 'Insulin Resistance', 'Diabetes']}, 'referencesModule': {'references': [{'pmid': '24656509', 'type': 'DERIVED', 'citation': 'Moosheer SM, Waldschutz W, Itariu BK, Brath H, Stulnig TM. A protein-enriched low glycemic index diet with omega-3 polyunsaturated fatty acid supplementation exerts beneficial effects on metabolic control in type 2 diabetes. Prim Care Diabetes. 2014 Dec;8(4):308-14. doi: 10.1016/j.pcd.2014.02.004. Epub 2014 Mar 19.'}]}, 'descriptionModule': {'briefSummary': 'Type 2 diabetes is tightly associated with overweight and obesity. Inflammatory processes are crucial triggers for insulin resistance that paves the way to type 2 diabetes. In a previous study the investigators have shown that n-3 polyunsaturated fatty acids diminish adipose tissue inflammation in morbidly obese non-diabetic subjects. in this observational study the investigators will apply n-3 polyunsaturated fatty acids as addition to a protein-enriched diet with low glycemic index to overweight and obese patients with insulin resistance, prediabetes and manifest type 2 diabetes over up to 6 months. Primary efficacy parameters are changes from baseline in HbA1c and body weight for for type 2 diabetes and all other patients, respectively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'overweight to obese insulin resistant, prediabetic and diabetic patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* overweight or obesity AND\n* insulin resistant OR pre-diabetes OR type 2 diabetes\n\nExclusion Criteria:\n\n* changes in anti-diabetic medication in the lat two months\n* acute illness during the last two weeks\n* HIV infection\n* hepatitis of other clinically significant hepatic disease other than non-alcoholic hepatic steatosis\n* severe or insufficiently treated cardiovascular, renal (GFR-MDRD \\< 60 ml/min) or pulmonary disease\n* Macroproteinuria (\\> 300 mg/g creatinine)\n* clinically significant or insufficiently treated thyroid disease\n* anemia\n* active malignant disease\n* inborn or acquired coagulopathy'}, 'identificationModule': {'nctId': 'NCT01474603', 'acronym': 'IMPEDE-DM2', 'briefTitle': 'Impact of n-3 Polyunsaturated Fatty Acids in a Protein-enriched Diet With Low GI in Type 2 Diabetes Patients', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': 'IMpact of n-3 Polyunsaturated Fatty Acids With a Protein-Enriched DiEt With Low Glycemic Index on Metabolic and Inflammatory Parameters in Type 2 Diabetic and Obese Patients: an Observational Pilot Study', 'orgStudyIdInfo': {'id': 'IMPEDE-DM2'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'overweight or obese diabetic', 'interventionNames': ['Dietary Supplement: n-3 PUFA in protein-enriched low-GI diet']}], 'interventions': [{'name': 'n-3 PUFA in protein-enriched low-GI diet', 'type': 'DIETARY_SUPPLEMENT', 'description': '3 g per day n-3 polyunsaturated fatty acids in a protein-enriched low-GI diet', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Dept. Medicine III, Medical University of Vienna', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Vienna', 'class': 'OTHER'}, 'collaborators': [{'name': 'Enervit Spa (company)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Thomas M Stulnig', 'investigatorAffiliation': 'Medical University of Vienna'}}}}