Overview

This trial is active, not recruiting.

Conditions hypertension, metabolic syndrome
Treatments comprehensive lifestyle modification, dash
Sponsor Universität Duisburg-Essen
Collaborator Kliniken Essen-Mitte
Start date April 2014
End date March 2015
Trial size 142 participants
Trial identifier NCT02099968, CORONA

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
comprehensive lifestyle modification
Vegeterian diet Fasting (1st week) Meditation Yoga Aerobic exercise
(Active Comparator)
dash
DASH diet (dietary approaches to stop hypertension) Aerobic exercise Progressive muscle relaxation

Primary Outcomes

Measure
Systolic blood pressure
time frame: 3 months
HOMA Index
time frame: 3 months

Secondary Outcomes

Measure
Blood pressure
time frame: 3 months, 6 months, 12 months
Blood pressure
time frame: 1 week, 3 months, 6 months, 12 months
Pulse wave velocity
time frame: 3 months, 6 months, 12 months
PROCAM
time frame: 1 week, 3 months, 6 months, 12 months
SCORE
time frame: 1 week, 3 months, 6 months, 12 months
Waist circumference
time frame: 1 week, 3 months, 6 months, 12 months
Weight
time frame: 1 week, 3 months, 6 months, 12 months
Blood glucose level
time frame: 1 week, 3 months, 6 months, 12 months
Blood insulin level
time frame: 1 week, 3 months, 6 months, 12 months
HbA1C
time frame: 3 months, 6 months, 12 months
Blood creatinine level
time frame: 1 week, 3 months, 6 months, 12 months
Total cholesterol
time frame: 1 week, 3 months, 6 months, 12 months
LDL cholesterol
time frame: 1 week, 3 months, 6 months, 12 months
HDL cholesterol
time frame: 1 week, 3 months, 6 months, 12 months
Medication use
time frame: 1 week, 3 months, 6 months, 12 months
HADS
time frame: 1 week, 3 months, 6 months, 12 months
POMS
time frame: 1 week, 3 months, 6 months, 12 months
CPSS
time frame: 3 months, 6 months, 12 months
SWE
time frame: 1 week, 3 months, 6 months, 12 months
SF-36
time frame: 3 months, 6 months, 12 months
MAAS
time frame: 3 months, 6 months, 12 months
SCS
time frame: 1 week, 3 months, 6 months, 12 months
Lifestyle questionnaire
time frame: 3 months, 6 months, 12 months
Hair steroid analysis
time frame: 6 months, 12 months
Bioelectrical impedance analysis
time frame: 1 week, 3 months, 6 months, 12 months
Waist/hip ratio
time frame: 1 week, 3 months, 6 months, 12 months
Immunophenotyping
time frame: 1 week, 3 months, 6 months, 12 months
Intestinal microbiota
time frame: 1 week, 3 months, 6 months, 12 months
Metabolomics
time frame: 1 week, 3 months, 6 months, 12 months
Gene expression profiling
time frame: 1 week, 3 months
Interleukin- 6
time frame: 1 week, 3 months, 6 months, 12 months
CRP
time frame: 1 week, 3 months, 6 months, 12 months
Uric acid
time frame: 1 week, 3 months, 6 months, 12 months
Insulin-like growth factor (IGF-1)
time frame: 1 week, 3 months, 6 months, 12 months
Safety
time frame: 1 week, 3 months, 6 months, 12 months
Framingham-Score
time frame: 1 week, 3 months, 6 months, 12 months
JBS3-Score
time frame: 1 week, 3 months, 6 months, 12 months

Eligibility Criteria

Male or female participants from 25 years up to 75 years old.

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 - Dementia - Other severe internal disease

Additional Information

Official title Intensivierte Ernährungs- Und Lebensstilmodifikation Bei Patienten Mit Bluthochdruck Und Kardiometabolischer Risikokonstellation. Eine Zweizentrische Randomisiert-kontrollierte Interventionsstudie über 6 Monate
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Universität Duisburg-Essen.