Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2026-03-14 @ 1:58 PM
Study NCT ID:
NCT02099968
Status:
COMPLETED
Last Update Posted:
2019-07-10
First Post:
2014-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comprehensive Lifestyle Modification for Patients With Hypertension and Metabolic Syndrome: a Multicenter Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 145}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-08', 'studyFirstSubmitDate': '2014-03-26', 'studyFirstSubmitQcDate': '2014-03-26', 'lastUpdatePostDateStruct': {'date': '2019-07-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-03-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Systolic blood pressure', 'timeFrame': '3 months', 'description': '24-hour ambulatory blood pressure'}, {'measure': 'HOMA Index', 'timeFrame': '3 months', 'description': 'Homeostatic Model Assessment'}], 'secondaryOutcomes': [{'measure': 'Blood pressure', 'timeFrame': '3 months, 6 months, 12 months', 'description': '24-hour ambulatory blood pressure'}, {'measure': 'Blood pressure', 'timeFrame': '1 week, 3 months, 6 months, 12 months', 'description': 'Sphygmomanometer'}, {'measure': 'Pulse wave velocity', 'timeFrame': '3 months, 6 months, 12 months', 'description': 'Pulse wave velocity (PWV) is a measure of arterial stiffness'}, {'measure': 'PROCAM', 'timeFrame': '1 week, 3 months, 6 months, 12 months', 'description': 'PROCAM risk score'}, {'measure': 'SCORE', 'timeFrame': '1 week, 3 months, 6 months, 12 months', 'description': 'SCORE risk score'}, {'measure': 'Waist circumference', 'timeFrame': '1 week, 3 months, 6 months, 12 months'}, {'measure': 'Weight', 'timeFrame': '1 week, 3 months, 6 months, 12 months'}, {'measure': 'Blood glucose level', 'timeFrame': '1 week, 3 months, 6 months, 12 months'}, {'measure': 'Blood insulin level', 'timeFrame': '1 week, 3 months, 6 months, 12 months'}, {'measure': 'HbA1C', 'timeFrame': '3 months, 6 months, 12 months', 'description': 'Longterm parameter for plasma glucose concentration.'}, {'measure': 'Blood creatinine level', 'timeFrame': '1 week, 3 months, 6 months, 12 months'}, {'measure': 'Total cholesterol', 'timeFrame': '1 week, 3 months, 6 months, 12 months'}, {'measure': 'LDL cholesterol', 'timeFrame': '1 week, 3 months, 6 months, 12 months'}, {'measure': 'HDL cholesterol', 'timeFrame': '1 week, 3 months, 6 months, 12 months'}, {'measure': 'Medication use', 'timeFrame': '1 week, 3 months, 6 months, 12 months'}, {'measure': 'HADS', 'timeFrame': '1 week, 3 months, 6 months, 12 months', 'description': 'Hospital Anxiety and Depression Scale'}, {'measure': 'POMS', 'timeFrame': '1 week, 3 months, 6 months, 12 months', 'description': 'Profile of Mood States'}, {'measure': 'CPSS', 'timeFrame': '3 months, 6 months, 12 months', 'description': 'Cohen Perceived Stress Scale'}, {'measure': 'SWE', 'timeFrame': '1 week, 3 months, 6 months, 12 months', 'description': 'General self-efficacy (Skala zur Allgemeinen Selbstwirksamkeitserwartung)'}, {'measure': 'SF-36', 'timeFrame': '3 months, 6 months, 12 months', 'description': 'Health-related quality of life'}, {'measure': 'MAAS', 'timeFrame': '3 months, 6 months, 12 months', 'description': 'Mindfulness Attention Awareness Scale'}, {'measure': 'SCS', 'timeFrame': '1 week, 3 months, 6 months, 12 months', 'description': 'Self-Compassion Scale'}, {'measure': 'Lifestyle questionnaire', 'timeFrame': '3 months, 6 months, 12 months', 'description': 'Questionnaire on physical activity, stress management, diet'}, {'measure': 'Hair steroid analysis', 'timeFrame': '6 months, 12 months', 'description': 'Assessment of long-term glucocorticoid levels in scalp hair.'}, {'measure': 'Bioelectrical impedance analysis', 'timeFrame': '1 week, 3 months, 6 months, 12 months', 'description': 'Method for estimating body composition (body fat).'}, {'measure': 'Waist/hip ratio', 'timeFrame': '1 week, 3 months, 6 months, 12 months'}, {'measure': 'Immunophenotyping', 'timeFrame': '1 week, 3 months, 6 months', 'description': 'Assessment of immunological subsets in PBMCs'}, {'measure': 'Intestinal microbiota', 'timeFrame': '1 week, 3 months, 6 months', 'description': 'Characterization of gut microbiota.'}, {'measure': 'Metabolomics', 'timeFrame': '1 week, 3 months', 'description': 'Assessment of small-molecule metabolite profiles from capillary blood'}, {'measure': 'Gene expression profiling', 'timeFrame': '1 week, 3 months', 'description': 'Assessment of gene expression profiles from PBMCs.'}, {'measure': 'Interleukin- 6', 'timeFrame': '1 week, 3 months, 6 months, 12 months'}, {'measure': 'CRP', 'timeFrame': '1 week, 3 months, 6 months, 12 months'}, {'measure': 'Uric acid', 'timeFrame': '1 week, 3 months, 6 months, 12 months'}, {'measure': 'Insulin-like growth factor (IGF-1)', 'timeFrame': '1 week, 3 months, 6 months, 12 months'}, {'measure': 'Adverse events', 'timeFrame': '1 week, 3 months, 6 months, 12 months', 'description': 'Adverse events'}, {'measure': 'Framingham-Score', 'timeFrame': '1 week, 3 months, 6 months, 12 months'}, {'measure': 'JBS3-Score', 'timeFrame': '1 week, 3 months, 6 months, 12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hypertension', 'Metabolic Syndrome']}, 'referencesModule': {'references': [{'pmid': '33785752', 'type': 'DERIVED', 'citation': 'Maifeld A, Bartolomaeus H, Lober U, Avery EG, Steckhan N, Marko L, Wilck N, Hamad I, Susnjar U, Mahler A, Hohmann C, Chen CY, Cramer H, Dobos G, Lesker TR, Strowig T, Dechend R, Bzdok D, Kleinewietfeld M, Michalsen A, Muller DN, Forslund SK. Fasting alters the gut microbiome reducing blood pressure and body weight in metabolic syndrome patients. Nat Commun. 2021 Mar 30;12(1):1970. doi: 10.1038/s41467-021-22097-0.'}]}, 'descriptionModule': {'briefSummary': 'Different forms of diet, e.g. Mediterranean diet, DASH diet, or fasting, have demonstrated efficacy in reducing elevated blood pressure. Moreover, Mediterranean diet, and fasting seem to be effective in improving insulin sensitivity in type 2 diabetes. Further, studies on meditation or mindfulness-based interventions have shown positive effects in patients with hypertension and/or type 2 diabetes. Comprehensive Lifestyle Modification, this is a combination of diet, exercise, and stress management, have improved coronary atherosclerosis. However, no studies have yet investigated the effects of Comprehensive Lifestyle Modification in patients with metabolic syndrome and/or in combination with fasting therapy.\n\nThis study is supported by a grant from the Corona-Foundation, Germany.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hypertension or antihypertensive medication or subclinical atherosclerosis\n* Metabolic syndrome\n* Basic mobility\n\nExclusion Criteria:\n\n* Diabetes type 1\n* Insulin bolus therapy\n* Coronary artery disease\n* Myocardial infarct, pulmonary embolism, or stroke within the past 3 months\n* Heart failure\n* Peripheral vascular disease\n* Chronic kidney disease\n* Eating disorder\n* Dementia\n* Other severe internal disease'}, 'identificationModule': {'nctId': 'NCT02099968', 'briefTitle': 'Comprehensive Lifestyle Modification for Patients With Hypertension and Metabolic Syndrome: a Multicenter Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'Universität Duisburg-Essen'}, 'officialTitle': 'Intensivierte Ernährungs- Und Lebensstilmodifikation Bei Patienten Mit Bluthochdruck Und Kardiometabolischer Risikokonstellation. Eine Zweizentrische Randomisiert-kontrollierte Interventionsstudie über 6 Monate', 'orgStudyIdInfo': {'id': 'CORONA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Comprehensive Lifestyle Modification', 'interventionNames': ['Behavioral: Comprehensive Lifestyle Modification']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Lifestyle Modification / modified DASH', 'interventionNames': ['Behavioral: Standard Lifestyle Modification / modified DASH']}], 'interventions': [{'name': 'Comprehensive Lifestyle Modification', 'type': 'BEHAVIORAL', 'description': '* Fasting (1st week), followed by:\n* Vegetarian and modified DASH diet (plant-based, low-salt)\n* Aerobic exercise\n* Stress reduction techniques: progressive muscle relaxation, meditation, yoga', 'armGroupLabels': ['Comprehensive Lifestyle Modification']}, {'name': 'Standard Lifestyle Modification / modified DASH', 'type': 'BEHAVIORAL', 'description': '* Modified DASH (vegetarian focused, plant-based, low-salt)\n* Aerobic exercise\n* Stress reduction techniques: progressive muscle relaxation', 'armGroupLabels': ['Standard Lifestyle Modification / modified DASH']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45276', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Immanuel Hospital Berlin, Department of Internal and Complementary Medicine', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '45276', 'city': 'Essen', 'country': 'Germany', 'facility': 'Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universität Duisburg-Essen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Kliniken Essen-Mitte', 'class': 'OTHER'}, {'name': 'Immanuel Hospital Berlin, Berlin, Germany', 'class': 'UNKNOWN'}, {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, {'name': 'University of Witten/Herdecke', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Department', 'investigatorFullName': 'Gustav Dobos', 'investigatorAffiliation': 'Universität Duisburg-Essen'}}}}