Ignite Creation Date:
2025-12-24 @ 6:36 PM
Ignite Modification Date:
2025-12-30 @ 6:23 AM
Study NCT ID:
NCT00725257
Status:
COMPLETED
Last Update Posted:
2008-07-30
First Post:
2008-07-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dietary Control of Type 2 Diabetes: Low-Carbohydrate Mediterranean Diet Versus Low-Fat Diet
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D038441', 'term': 'Diet, Mediterranean'}, {'id': 'D018752', 'term': 'Diet, Fat-Restricted'}], 'ancestors': [{'id': 'D000095500', 'term': 'Diet, Plant-Based'}, {'id': 'D004035', 'term': 'Diet Therapy'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004032', 'term': 'Diet'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 215}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-07', 'completionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-07-28', 'studyFirstSubmitDate': '2008-07-28', 'studyFirstSubmitQcDate': '2008-07-28', 'lastUpdatePostDateStruct': {'date': '2008-07-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-07-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hemoglobin A1c', 'timeFrame': 'Every sixth month'}], 'secondaryOutcomes': [{'measure': 'Time to introduction of an oral hypoglycemic agent', 'timeFrame': 'Every year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '18635428', 'type': 'BACKGROUND', 'citation': 'Shai I, Schwarzfuchs D, Henkin Y, Shahar DR, Witkow S, Greenberg I, Golan R, Fraser D, Bolotin A, Vardi H, Tangi-Rozental O, Zuk-Ramot R, Sarusi B, Brickner D, Schwartz Z, Sheiner E, Marko R, Katorza E, Thiery J, Fiedler GM, Bluher M, Stumvoll M, Stampfer MJ; Dietary Intervention Randomized Controlled Trial (DIRECT) Group. Weight loss with a low-carbohydrate, Mediterranean, or low-fat diet. N Engl J Med. 2008 Jul 17;359(3):229-41. doi: 10.1056/NEJMoa0708681.'}, {'pmid': '17301311', 'type': 'BACKGROUND', 'citation': 'Esposito K, Ciotola M, Giugliano D. Low-carbohydrate diet and coronary heart disease in women. N Engl J Med. 2007 Feb 15;356(7):750; author reply 750-2. doi: 10.1056/NEJMc063464. No abstract available.'}, {'pmid': '27798369', 'type': 'DERIVED', 'citation': 'Maiorino MI, Bellastella G, Petrizzo M, Gicchino M, Caputo M, Giugliano D, Esposito K. Effect of a Mediterranean diet on endothelial progenitor cells and carotid intima-media thickness in type 2 diabetes: Follow-up of a randomized trial. Eur J Prev Cardiol. 2017 Mar;24(4):399-408. doi: 10.1177/2047487316676133. Epub 2016 Oct 27.'}, {'pmid': '27614727', 'type': 'DERIVED', 'citation': 'Maiorino MI, Bellastella G, Caputo M, Castaldo F, Improta MR, Giugliano D, Esposito K. Effects of Mediterranean diet on sexual function in people with newly diagnosed type 2 diabetes: The MEDITA trial. J Diabetes Complications. 2016 Nov-Dec;30(8):1519-1524. doi: 10.1016/j.jdiacomp.2016.08.007. Epub 2016 Aug 12.'}, {'pmid': '27352954', 'type': 'DERIVED', 'citation': 'Maiorino MI, Bellastella G, Chiodini P, Romano O, Scappaticcio L, Giugliano D, Esposito K. Primary Prevention of Sexual Dysfunction With Mediterranean Diet in Type 2 Diabetes: The MEDITA Randomized Trial. Diabetes Care. 2016 Sep;39(9):e143-4. doi: 10.2337/dc16-0910. Epub 2016 Jun 28. No abstract available.'}, {'pmid': '26740638', 'type': 'DERIVED', 'citation': 'Maiorino MI, Bellastella G, Petrizzo M, Scappaticcio L, Giugliano D, Esposito K. Anti-inflammatory Effect of Mediterranean Diet in Type 2 Diabetes Is Durable: 8-Year Follow-up of a Controlled Trial. Diabetes Care. 2016 Mar;39(3):e44-5. doi: 10.2337/dc15-2356. Epub 2016 Jan 6. No abstract available.'}, {'pmid': '24722497', 'type': 'DERIVED', 'citation': 'Esposito K, Maiorino MI, Petrizzo M, Bellastella G, Giugliano D. The effects of a Mediterranean diet on the need for diabetes drugs and remission of newly diagnosed type 2 diabetes: follow-up of a randomized trial. Diabetes Care. 2014 Jul;37(7):1824-30. doi: 10.2337/dc13-2899. Epub 2014 Apr 10.'}]}, 'descriptionModule': {'briefSummary': 'The major environmental factors that increase the risk of type 2 diabetes, presumably in the setting of genetic risk, are overnutrition and a sedentary lifestyle, with consequent overweight and obesity. The high rate of weight regain has limited the role of lifestyle interventions as an effective means of controlling glycemia long term. The aims of the present study were: 1) To compare the effectiveness and safety of two nutritional protocols - namely low-carbohydrate Mediterranean diet or low-fat diet - in newly-diagnosed, drug-naive overweight patients with type 2 diabetes mellitus. The primary aim of the study was the effect on hemoglobin A1c levels; secondary aims were time to introduction of the first hypoglycemic agent, prevalence of the metabolic syndrome, percentage of patients meeting ADA goals for risk factors (HbA1c, blood pressure, LDL-cholesterol, percentage of patients with HbA1c \\< 7%.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 diabetes mellitus (ADA criteria)\n* BMI (body mass index) \\> 25 kg/M2\n* Hemoglobin A1c (HbA1c) \\< 11%; Blood pressure \\< 160 (systolic) and 100 (diastolic) mm Hg\n* Triglyceride levels \\< 500 mg/dl.\n\nExclusion Criteria:\n\n* Pregnancy or breast-feeding\n* Previous use of insulin or oral antidiabetic drugs\n* Investigational drug within the previous 3 months\n* Use of agents affecting glycemic control (systemic steroids and weight loss drugs)\n* Patients with history of alcohol or illicit drug abuse\n* Patients with liver enzymes higher than three times the upper limit of normal\n* Serum creatinine \\> 1.4 mg/dl.'}, 'identificationModule': {'nctId': 'NCT00725257', 'briefTitle': 'Dietary Control of Type 2 Diabetes: Low-Carbohydrate Mediterranean Diet Versus Low-Fat Diet', 'organization': {'class': 'OTHER', 'fullName': 'University of Campania Luigi Vanvitelli'}, 'officialTitle': 'Effect of a Low-Carbohydrate Mediterranean Diet or Low-Fat Diet in Newly-Diagnosed Type 2 Diabetic Patients', 'orgStudyIdInfo': {'id': 'DGMM/4/2004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Low-carbohydrate, energy-restricted, Mediterranean-type diet', 'interventionNames': ['Other: Mediterranean diet']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Low-fat diet', 'interventionNames': ['Other: Low-fat diet']}], 'interventions': [{'name': 'Mediterranean diet', 'type': 'OTHER', 'description': 'The recommended composition of the dietary regimen was as follows: Carbohydrate 40 to 50%, protein 15 to 20%; fat 30 to 40%; saturated fat less than 10%.', 'armGroupLabels': ['1']}, {'name': 'Low-fat diet', 'type': 'OTHER', 'description': 'The recommended composition of the dietary regimen was as follows: Fat less than 30%; carbohydrate 50 to 60%, protein 15 to 20%; saturated fat less than 10%.', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80138', 'city': 'Naples', 'country': 'Italy', 'facility': 'Department of Geriatrics and Metabolic Diseases', 'geoPoint': {'lat': 40.85216, 'lon': 14.26811}}], 'overallOfficials': [{'name': 'Dario Giugliano, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Geriatrics and Metabolic Diseases'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Campania Luigi Vanvitelli', 'class': 'OTHER'}, 'responsibleParty': {'oldOrganization': 'Department of Geriatrics and Metabolic Diseases'}}}}