Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2025-12-25 @ 4:22 PM
Study NCT ID:
NCT01004757
Status:
UNKNOWN
Last Update Posted:
2009-10-30
First Post:
2009-10-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Low Versus High Carbohydrate Diet During Rehabilitation on Cardiovascular Function and Metabolism in 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': 'D050177', 'term': 'Overweight'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], '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': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018752', 'term': 'Diet, Fat-Restricted'}], 'ancestors': [{'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': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 41}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-10', 'completionDateStruct': {'date': '2010-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-10-29', 'studyFirstSubmitDate': '2009-10-29', 'studyFirstSubmitQcDate': '2009-10-29', 'lastUpdatePostDateStruct': {'date': '2009-10-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-10-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'myocardial diastolic function', 'timeFrame': '2-3 weeks treatment period'}], 'secondaryOutcomes': [{'measure': 'triglycerides, insulin resistance', 'timeFrame': '2-3 weeks treatment period'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['diastolic function', 'postmeal glucose', 'insulin resistance', 'low carb diet', 'type 2 diabetes'], 'conditions': ['Type 2 Diabetes Mellitus', 'Overweight']}, 'referencesModule': {'references': [{'pmid': '18700873', 'type': 'BACKGROUND', 'citation': 'Hession M, Rolland C, Kulkarni U, Wise A, Broom J. Systematic review of randomized controlled trials of low-carbohydrate vs. low-fat/low-calorie diets in the management of obesity and its comorbidities. Obes Rev. 2009 Jan;10(1):36-50. doi: 10.1111/j.1467-789X.2008.00518.x. Epub 2008 Aug 11.'}, {'pmid': '15331548', 'type': 'BACKGROUND', 'citation': 'Gannon MC, Nuttall FQ. Effect of a high-protein, low-carbohydrate diet on blood glucose control in people with type 2 diabetes. Diabetes. 2004 Sep;53(9):2375-82. doi: 10.2337/diabetes.53.9.2375.'}, {'pmid': '17498573', 'type': 'BACKGROUND', 'citation': 'Yu CM, Sanderson JE, Marwick TH, Oh JK. Tissue Doppler imaging a new prognosticator for cardiovascular diseases. J Am Coll Cardiol. 2007 May 15;49(19):1903-14. doi: 10.1016/j.jacc.2007.01.078. Epub 2007 Apr 30.'}, {'pmid': '16305069', 'type': 'BACKGROUND', 'citation': 'Von Bibra H, Thrainsdottir IS, Hansen A, Dounis V, Malmberg K, Ryden L. Tissue Doppler imaging for the detection and quantitation of myocardial dysfunction in patients with type 2 diabetes mellitus. Diab Vasc Dis Res. 2005 Feb;2(1):24-30. doi: 10.3132/dvdr.2005.002.'}, {'pmid': '15547039', 'type': 'BACKGROUND', 'citation': 'von Bibra H, Hansen A, Dounis V, Bystedt T, Malmberg K, Ryden L. Augmented metabolic control improves myocardial diastolic function and perfusion in patients with non-insulin dependent diabetes. Heart. 2004 Dec;90(12):1483-4. doi: 10.1136/hrt.2003.020842. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Compared to the traditional low fat diet for overweight patients with type 2 diabetes, recent evidence shows that low carbohydrate/high protein diets lower triglycerides and postprandial glucose levels more effectively. However, it is not known, whether this diet can also improve the subclinically impaired myocardial function in type 2 diabetes. This prospective parallel group and cross over design study compares the effects of a low glycemic and insulinemic diet (LOGI®) with an isocaloric traditional low fat diet during a three weeks rehabilitation programme with aerobic exercise for overweight type 2 diabetes patients testing the hypothesis, that the low carbohydrate diet improves myocardial function and insulin resistance.', 'detailedDescription': 'This is a single center, short term therapy controlled and prospective study with blinded analyses of the ultrasound data in 41 patients with type 2 diabetes either on dietary control or oral antidiabetic medication. After recruitment and informed consent, patients are randomized to two treatment arms matched for age and concomittant antidiabetic and cardiovascular medication In one treatment arm, the diet is based on the LOGI components: 25% low glycemic index carbohydrates, 30% protein, 45% fat, taken for 3 weeks combined with aerobic exercise, while in the other treatment arm, the isocaloric traditional low fat diet is based on 55% mixed glycemic index carbohydrates, 20 % protein and 25% fat taken for three weeks and combined with the same aerobic exercise protocoll but followed by a two weeks period with LOGI diet and maintained exercise. In both treatment arms, antidiabetic and antihypertensive medication are maintained and/or adapted as necessary and recorded.\n\nAll patients receive life style instructions and are updated in their skills of measuring quantity of foods and designing diet plans based on food groups. Laboratory, clinical and ultrasound investigations are performed before and at the end of the three weeks programme and, in the cross over group, also at the end of the subsequent diet programme.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* type 2 diabetes\n* oral antidiabetic medication or dietary control\n* overweight\n\nExclusion Criteria:\n\n* coronary artery disease'}, 'identificationModule': {'nctId': 'NCT01004757', 'briefTitle': 'Effects of Low Versus High Carbohydrate Diet During Rehabilitation on Cardiovascular Function and Metabolism in Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Munich Municipal Hospital'}, 'officialTitle': 'Improvement of Myocardial Function and Metabolic Syndrome in Type 2 Diabetes Patients by a Low Glycemic and Insulinemic Diet (LOGI®) Compared to the Traditional Low Fat Diet - a Prospective Parallel Group/Cross Over Study', 'orgStudyIdInfo': {'id': 'LOGILoFaReha'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'LOGI diet', 'description': 'diet based on 25% low glycemic index carbohydrates, 30% protein and 45% fat combined with heart rate controlled, aerobic exercise', 'interventionNames': ['Other: LOGI diet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Low Fat diet', 'description': 'cross over design of three weeks Low Fat diet followed by two weeks LOGI diet always combined with heart rate controlled aerobic exercise', 'interventionNames': ['Other: Low Fat diet']}], 'interventions': [{'name': 'LOGI diet', 'type': 'OTHER', 'description': 'diet based on 25% low glycemic index carbohydrates, 30% protein and 45% fat combined with heart rate controlled aerobic exercise for three weeks', 'armGroupLabels': ['LOGI diet']}, {'name': 'Low Fat diet', 'type': 'OTHER', 'description': 'traditional low fat diet based on 55% mixed glycemic index carbohydrates, 20% protein and 25% fat for three weeks followed by LOGI diet for two weeks, always combined with heart rate controlled aerobic exercise', 'armGroupLabels': ['Low Fat diet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '81925', 'city': 'Munich', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Staedt. Klinikum Muenchen-Bogenhausen', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}], 'overallOfficials': [{'name': 'Helene von Bibra, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Munich Academic Teaching Hospital Bogenhausen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Munich Municipal Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Stately Pension System (LVA) Baden-Wuertemberg', 'class': 'UNKNOWN'}, {'name': 'Ueberruh Rehabilitation Clinic, Isny, Baden-Wuertemberg', 'class': 'UNKNOWN'}], 'responsibleParty': {'oldNameTitle': 'Prof. Dr. Helene von Bibra', 'oldOrganization': 'Munich Municipal Hospital'}}}}