Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2025-12-25 @ 9:16 PM
Study NCT ID:
NCT01025856
Status:
COMPLETED
Last Update Posted:
2012-12-05
First Post:
2009-12-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Combined Nutritional and Exercise Strategies to Reduce Liver Fat Content in Patients 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'}, {'id': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D009043', 'term': 'Motor Activity'}], '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'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-12-03', 'studyFirstSubmitDate': '2009-12-02', 'studyFirstSubmitQcDate': '2009-12-03', 'lastUpdatePostDateStruct': {'date': '2012-12-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Liver fat content', 'timeFrame': '0 and 8 weeks'}, {'measure': 'postprandial lipids metabolism', 'timeFrame': '0 and 8 weeks'}], 'secondaryOutcomes': [{'measure': 'changes in body fat distribution', 'timeFrame': '0 and 8 weeks'}, {'measure': 'oxidative stress and inflammation', 'timeFrame': '0 and 8 weeks'}, {'measure': 'adipose tissue lipolytic activities', 'timeFrame': '0 and 8 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['liver fat', 'postprandial lipids metabolism', 'diet', 'exercise', 'type 2 diabetes'], 'conditions': ['Postprandial Lipids Metabolism', 'Type 2 Diabetes']}, 'referencesModule': {'references': [{'pmid': '27650287', 'type': 'DERIVED', 'citation': 'Bozzetto L, Costabile G, Luongo D, Naviglio D, Cicala V, Piantadosi C, Patti L, Cipriano P, Annuzzi G, Rivellese AA. Reduction in liver fat by dietary MUFA in type 2 diabetes is helped by enhanced hepatic fat oxidation. Diabetologia. 2016 Dec;59(12):2697-2701. doi: 10.1007/s00125-016-4110-5. Epub 2016 Sep 20.'}, {'pmid': '24132660', 'type': 'DERIVED', 'citation': 'Bozzetto L, Annuzzi G, Costabile G, Costagliola L, Giorgini M, Alderisio A, Strazzullo A, Patti L, Cipriano P, Mangione A, Vitelli A, Vigorito C, Riccardi G, Rivellese AA. A CHO/fibre diet reduces and a MUFA diet increases postprandial lipaemia in type 2 diabetes: no supplementary effects of low-volume physical training. Acta Diabetol. 2014;51(3):385-93. doi: 10.1007/s00592-013-0522-6. Epub 2013 Oct 17.'}, {'pmid': '22723581', 'type': 'DERIVED', 'citation': 'Bozzetto L, Prinster A, Annuzzi G, Costagliola L, Mangione A, Vitelli A, Mazzarella R, Longobardo M, Mancini M, Vigorito C, Riccardi G, Rivellese AA. Liver fat is reduced by an isoenergetic MUFA diet in a controlled randomized study in type 2 diabetic patients. Diabetes Care. 2012 Jul;35(7):1429-35. doi: 10.2337/dc12-0033.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study will be to evaluate in patients with type 2 diabetes the effects on liver fat of an intervention with a diet relatively rich in CHO/rich in fibre/low GI or a diet rich in MUFA, either combined or not with a structured program of physical exercise, with emphasis on mechanisms possibly underlining these effects, namely changes in postprandial triglyceride-rich lipoproteins, body fat distribution, insulin sensitivity, oxidative stress and inflammation, adipose tissue lipolytic activities, aerobic capacity and endothelial function.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and postmenopausal women\n* Age 35-65 years\n* BMI 27- 34 kg/m2\n* HbA1c \\<8%\n* Fasting plasma cholesterol \\<250 mg/dl\n* Fasting plasma triglycerides \\<300 mg/dl\n\nExclusion Criteria:\n\n* Hypolipidemic drugs\n* Plasma creatinine \\>1.7 mg/dl transaminases \\> 2 norma values\n* Ischemic heart disease or positive treadmill stress test\n* High intensity regular physical activity\n* Any disease or chronic or/and acute condition contraindicating physical activity(anaemia, and infectious, neoplastic, neurological and osteoarticular diseases).'}, 'identificationModule': {'nctId': 'NCT01025856', 'briefTitle': 'Combined Nutritional and Exercise Strategies to Reduce Liver Fat Content in Patients With Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Federico II University'}, 'officialTitle': 'Combined Nutritional and Exercise Strategies to Reduce Liver Fat Content in Patients With Type 2 Diabetes', 'orgStudyIdInfo': {'id': '46/09'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'high fibre/low glycemic index diet - P A', 'description': 'patients will follow for two months a diet high fibre/low glycemic index without physical activity program', 'interventionNames': ['Other: High fibre/low glycemic index diet-PA']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Rich in MUFA diet - PA', 'description': 'Patients will follow for two months a rich in MUFA diet without a physical activity program.', 'interventionNames': ['Other: Rich in MUFA diet -PA']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'high fibre/low glycemic index diet+PA', 'description': 'Patients will follow for two months a high fibre and low glycemic index diet associated with a physical activity program.', 'interventionNames': ['Other: high fiber/low glycemic index diet + pa']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Rich in MUFA diet+PA', 'description': 'Patients will follow for 2 months a rich in MUFA diet with a physical activity program.', 'interventionNames': ['Other: Rich in MUFA diet+PA']}], 'interventions': [{'name': 'Rich in MUFA diet -PA', 'type': 'OTHER', 'description': 'The patients will follow a rich in MUFA diet without a physical activity program.', 'armGroupLabels': ['Rich in MUFA diet - PA']}, {'name': 'high fiber/low glycemic index diet + pa', 'type': 'OTHER', 'description': 'patients will follow for two months a high fibre/ low glycemic index diet with a physical activity program.', 'armGroupLabels': ['high fibre/low glycemic index diet+PA']}, {'name': 'Rich in MUFA diet+PA', 'type': 'OTHER', 'description': 'Patients will follow for two months a rich in MUFA diet with a physical activity program.', 'armGroupLabels': ['Rich in MUFA diet+PA']}, {'name': 'High fibre/low glycemic index diet-PA', 'type': 'OTHER', 'description': 'Patients will follow for two months a high fibre/low glycemic index diet without a physical activity program.', 'armGroupLabels': ['high fibre/low glycemic index diet - P A']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federico II University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PA', 'investigatorFullName': 'rivellese angela', 'investigatorAffiliation': 'Federico II University'}}}}