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Comprehensive Lifestyle Modification for Patients With Hypertension and Metabolic Syndrome: a Multicenter Randomized Controlled Trial

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02099968
First Posted: March 31, 2014
Last Update Posted: May 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Kliniken Essen-Mitte
Immanuel Hospital Berlin, Berlin, Germany
Charite University, Berlin, Germany
University of Witten/Herdecke
Information provided by (Responsible Party):
Gustav Dobos, Universität Duisburg-Essen
  Purpose

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.


Condition Intervention
Hypertension Metabolic Syndrome Behavioral: Comprehensive Lifestyle Modification Behavioral: DASH

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intensivierte Ernährungs- Und Lebensstilmodifikation Bei Patienten Mit Bluthochdruck Und Kardiometabolischer Risikokonstellation. Eine Zweizentrische Randomisiert-kontrollierte Interventionsstudie über 6 Monate

Resource links provided by NLM:


Further study details as provided by Gustav Dobos, Universität Duisburg-Essen:

Primary Outcome Measures:
  • Systolic blood pressure [ Time Frame: 3 months ]
    24-hour ambulatory blood pressure

  • HOMA Index [ Time Frame: 3 months ]
    Homeostatic Model Assessment


Secondary Outcome Measures:
  • Blood pressure [ Time Frame: 3 months, 6 months, 12 months ]
    24-hour ambulatory blood pressure

  • Blood pressure [ Time Frame: 1 week, 3 months, 6 months, 12 months ]
    Sphygmomanometer

  • Pulse wave velocity [ Time Frame: 3 months, 6 months, 12 months ]
    Pulse wave velocity (PWV) is a measure of arterial stiffness

  • PROCAM [ Time Frame: 1 week, 3 months, 6 months, 12 months ]
    PROCAM risk score

  • SCORE [ Time Frame: 1 week, 3 months, 6 months, 12 months ]
    SCORE risk score

  • 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 ]
    Longterm parameter for plasma glucose concentration.

  • 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 ]
    Hospital Anxiety and Depression Scale

  • POMS [ Time Frame: 1 week, 3 months, 6 months, 12 months ]
    Profile of Mood States

  • CPSS [ Time Frame: 3 months, 6 months, 12 months ]
    Cohen Perceived Stress Scale

  • SWE [ Time Frame: 1 week, 3 months, 6 months, 12 months ]
    General self-efficacy (Skala zur Allgemeinen Selbstwirksamkeitserwartung)

  • SF-36 [ Time Frame: 3 months, 6 months, 12 months ]
    Health-related quality of life

  • MAAS [ Time Frame: 3 months, 6 months, 12 months ]
    Mindfulness Attention Awareness Scale

  • SCS [ Time Frame: 1 week, 3 months, 6 months, 12 months ]
    Self-Compassion Scale

  • Lifestyle questionnaire [ Time Frame: 3 months, 6 months, 12 months ]
    Questionnaire on physical activity, stress management, diet

  • Hair steroid analysis [ Time Frame: 6 months, 12 months ]
    Assessment of long-term glucocorticoid levels in scalp hair.

  • Bioelectrical impedance analysis [ Time Frame: 1 week, 3 months, 6 months, 12 months ]
    Method for estimating body composition (body fat).

  • Waist/hip ratio [ Time Frame: 1 week, 3 months, 6 months, 12 months ]
  • Immunophenotyping [ Time Frame: 1 week, 3 months, 6 months, 12 months ]
    Assessment of membrane protein expression in PBMCs.

  • Intestinal microbiota [ Time Frame: 1 week, 3 months, 6 months, 12 months ]
    Characterization of gut microbiota.

  • Metabolomics [ Time Frame: 1 week, 3 months, 6 months, 12 months ]
    Assessment of small-molecule metabolite profiles from capillary blood

  • Gene expression profiling [ Time Frame: 1 week, 3 months ]
    Assessment of gene expression profiles from PBMCs.

  • 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 ]
    Adverse events

  • Framingham-Score [ Time Frame: 1 week, 3 months, 6 months, 12 months ]
  • JBS3-Score [ Time Frame: 1 week, 3 months, 6 months, 12 months ]

Enrollment: 145
Study Start Date: April 2014
Study Completion Date: December 2015
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Comprehensive Lifestyle Modification Behavioral: Comprehensive Lifestyle Modification
  • Vegeterian diet
  • Fasting (1st week)
  • Meditation
  • Yoga
  • Aerobic exercise
Active Comparator: DASH Behavioral: DASH
  • DASH diet (dietary approaches to stop hypertension)
  • Aerobic exercise
  • Progressive muscle relaxation

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   25 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • Dementia
  • Other severe internal disease
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02099968


Locations
Germany
Immanuel Hospital Berlin, Department of Internal and Complementary Medicine
Berlin, Germany, 45276
Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen
Essen, Germany, 45276
Sponsors and Collaborators
Universität Duisburg-Essen
Kliniken Essen-Mitte
Immanuel Hospital Berlin, Berlin, Germany
Charite University, Berlin, Germany
University of Witten/Herdecke
  More Information

Responsible Party: Gustav Dobos, Head of Department, Universität Duisburg-Essen
ClinicalTrials.gov Identifier: NCT02099968     History of Changes
Other Study ID Numbers: CORONA
First Submitted: March 26, 2014
First Posted: March 31, 2014
Last Update Posted: May 24, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
Syndrome
Hypertension
Metabolic Syndrome X
Disease
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases