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

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ClinicalTrials.gov Identifier: NCT02099968
Recruitment Status : Completed
First Posted : March 31, 2014
Last Update Posted : July 10, 2019
Sponsor:
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

Study Description
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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.


Condition or disease Intervention/treatment Phase
Hypertension Metabolic Syndrome Behavioral: Comprehensive Lifestyle Modification Behavioral: Standard Lifestyle Modification / modified DASH Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 145 participants
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
Study Start Date : April 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Comprehensive Lifestyle Modification Behavioral: Comprehensive Lifestyle Modification
  • Fasting (1st week), followed by:
  • Vegetarian and modified DASH diet (plant-based, low-salt)
  • Aerobic exercise
  • Stress reduction techniques: progressive muscle relaxation, meditation, yoga
Active Comparator: Standard Lifestyle Modification / modified DASH Behavioral: Standard Lifestyle Modification / modified DASH
  • Modified DASH (vegetarian focused, plant-based, low-salt)
  • Aerobic exercise
  • Stress reduction techniques: progressive muscle relaxation


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

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


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

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

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

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

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

  6. Waist circumference [ Time Frame: 1 week, 3 months, 6 months, 12 months ]
  7. Weight [ Time Frame: 1 week, 3 months, 6 months, 12 months ]
  8. Blood glucose level [ Time Frame: 1 week, 3 months, 6 months, 12 months ]
  9. Blood insulin level [ Time Frame: 1 week, 3 months, 6 months, 12 months ]
  10. HbA1C [ Time Frame: 3 months, 6 months, 12 months ]
    Longterm parameter for plasma glucose concentration.

  11. Blood creatinine level [ Time Frame: 1 week, 3 months, 6 months, 12 months ]
  12. Total cholesterol [ Time Frame: 1 week, 3 months, 6 months, 12 months ]
  13. LDL cholesterol [ Time Frame: 1 week, 3 months, 6 months, 12 months ]
  14. HDL cholesterol [ Time Frame: 1 week, 3 months, 6 months, 12 months ]
  15. Medication use [ Time Frame: 1 week, 3 months, 6 months, 12 months ]
  16. HADS [ Time Frame: 1 week, 3 months, 6 months, 12 months ]
    Hospital Anxiety and Depression Scale

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

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

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

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

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

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

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

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

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

  26. Waist/hip ratio [ Time Frame: 1 week, 3 months, 6 months, 12 months ]
  27. Immunophenotyping [ Time Frame: 1 week, 3 months, 6 months ]
    Assessment of immunological subsets in PBMCs

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

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

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

  31. Interleukin- 6 [ Time Frame: 1 week, 3 months, 6 months, 12 months ]
  32. CRP [ Time Frame: 1 week, 3 months, 6 months, 12 months ]
  33. Uric acid [ Time Frame: 1 week, 3 months, 6 months, 12 months ]
  34. Insulin-like growth factor (IGF-1) [ Time Frame: 1 week, 3 months, 6 months, 12 months ]
  35. Adverse events [ Time Frame: 1 week, 3 months, 6 months, 12 months ]
    Adverse events

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

Eligibility Criteria
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Ages Eligible for Study:   25 Years to 75 Years   (Adult, Older Adult)
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
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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
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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
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Gustav Dobos, Head of Department, Universität Duisburg-Essen
ClinicalTrials.gov Identifier: NCT02099968    
Other Study ID Numbers: CORONA
First Posted: March 31, 2014    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: July 2019
Additional relevant MeSH terms:
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Hypertension
Metabolic Syndrome
Syndrome
Disease
Pathologic Processes
Vascular Diseases
 Cardiovascular Diseases
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases