Intensivierte Ernährungs- Und Lebensstilmodifikation Bei Patienten Mit Bluthochdruck Und Kardiometabolischer Risikokonstellation. Eine Zweizentrische Randomisiert-kontrollierte Interventionsstudie über 6 Monate
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 145
- 试验地点
- 4
- 主要终点
- Systolic blood pressure
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hypertension or antihypertensive medication or subclinical atherosclerosis
- •Metabolic syndrome
- •Basic mobility
排除标准
- •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
研究组 & 干预措施
Comprehensive Lifestyle Modification
干预措施: Comprehensive Lifestyle Modification (Behavioral)
Standard Lifestyle Modification / modified DASH
干预措施: Standard Lifestyle Modification / modified DASH (Behavioral)
结局指标
主要结局
Systolic blood pressure
时间窗: 3 months
24-hour ambulatory blood pressure
HOMA Index
时间窗: 3 months
Homeostatic Model Assessment
次要结局
- 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)
研究者
Gustav Dobos
Head of Department
Universität Duisburg-Essen