Intensivierte Ernährungs- Und Lebensstilmodifikation Bei Patienten Mit Bluthochdruck Und Kardiometabolischer Risikokonstellation. Eine Zweizentrische Randomisiert-kontrollierte Interventionsstudie über 6 Monate
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hypertension
- Sponsor
- Universität Duisburg-Essen
- Enrollment
- 145
- Locations
- 2
- Primary Endpoint
- Systolic blood pressure
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
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.
This study is supported by a grant from the Corona-Foundation, Germany.
Investigators
Gustav Dobos
Head of Department
Universität Duisburg-Essen
Eligibility Criteria
Inclusion Criteria
- •Hypertension or antihypertensive medication or subclinical atherosclerosis
- •Metabolic syndrome
- •Basic mobility
Exclusion Criteria
- •Diabetes type 1
- •Insulin bolus therapy
- •Coronary artery disease
- •Myocardial infarct, pulmonary embolism, or stroke within the past 3 months
- •Heart failure
- •Peripheral vascular disease
- •Chronic kidney disease
- •Eating disorder
- •Other severe internal disease
Outcomes
Primary Outcomes
Systolic blood pressure
Time Frame: 3 months
24-hour ambulatory blood pressure
HOMA Index
Time Frame: 3 months
Homeostatic Model Assessment
Secondary Outcomes
- CRP(1 week, 3 months, 6 months, 12 months)
- Framingham-Score(1 week, 3 months, 6 months, 12 months)
- JBS3-Score(1 week, 3 months, 6 months, 12 months)
- SCORE(1 week, 3 months, 6 months, 12 months)
- Blood creatinine level(1 week, 3 months, 6 months, 12 months)
- HDL cholesterol(1 week, 3 months, 6 months, 12 months)
- POMS(1 week, 3 months, 6 months, 12 months)
- SWE(1 week, 3 months, 6 months, 12 months)
- SCS(1 week, 3 months, 6 months, 12 months)
- HADS(1 week, 3 months, 6 months, 12 months)
- Waist circumference(1 week, 3 months, 6 months, 12 months)
- Blood glucose level(1 week, 3 months, 6 months, 12 months)
- PROCAM(1 week, 3 months, 6 months, 12 months)
- Blood insulin level(1 week, 3 months, 6 months, 12 months)
- HbA1C(3 months, 6 months, 12 months)
- Pulse wave velocity(3 months, 6 months, 12 months)
- SF-36(3 months, 6 months, 12 months)
- MAAS(3 months, 6 months, 12 months)
- Bioelectrical impedance analysis(1 week, 3 months, 6 months, 12 months)
- Immunophenotyping(1 week, 3 months, 6 months)
- Gene expression profiling(1 week, 3 months)
- Blood pressure(1 week, 3 months, 6 months, 12 months)
- Weight(1 week, 3 months, 6 months, 12 months)
- Total cholesterol(1 week, 3 months, 6 months, 12 months)
- LDL cholesterol(1 week, 3 months, 6 months, 12 months)
- Medication use(1 week, 3 months, 6 months, 12 months)
- CPSS(3 months, 6 months, 12 months)
- Lifestyle questionnaire(3 months, 6 months, 12 months)
- Hair steroid analysis(6 months, 12 months)
- Waist/hip ratio(1 week, 3 months, 6 months, 12 months)
- Insulin-like growth factor (IGF-1)(1 week, 3 months, 6 months, 12 months)
- Intestinal microbiota(1 week, 3 months, 6 months)
- Interleukin- 6(1 week, 3 months, 6 months, 12 months)
- Uric acid(1 week, 3 months, 6 months, 12 months)
- Metabolomics(1 week, 3 months)
- Adverse events(1 week, 3 months, 6 months, 12 months)