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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Universität Duisburg-Essen
Sponsor:
Collaborators:
Kliniken Essen-Mitte
Immanuel Hospital Berlin, Berlin, Germany
Charité University Medical Center, Berlin, Germany
University of Witten/Herdecke
Information provided by (Responsible Party):
Gustav Dobos, Universität Duisburg-Essen
ClinicalTrials.gov Identifier:
NCT02099968
First received: March 26, 2014
Last updated: April 9, 2014
Last verified: April 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 Universität Duisburg-Essen:

Primary Outcome Measures:
  • Systolic blood pressure [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    24-hour ambulatory blood pressure

  • HOMA Index [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Homeostatic Model Assessment


Secondary Outcome Measures:
  • Blood pressure [ Time Frame: 3 months, 6 months, 12 months ] [ Designated as safety issue: No ]
    24-hour ambulatory blood pressure

  • Blood pressure [ Time Frame: 1 week, 3 months, 6 months, 12 months ] [ Designated as safety issue: No ]
    Sphygmomanometer

  • Pulse wave velocity [ Time Frame: 3 months, 6 months, 12 months ] [ Designated as safety issue: No ]
    Pulse wave velocity (PWV) is a measure of arterial stiffness

  • PROCAM [ Time Frame: 1 week, 3 months, 6 months, 12 months ] [ Designated as safety issue: No ]
    PROCAM risk score

  • SCORE [ Time Frame: 1 week, 3 months, 6 months, 12 months ] [ Designated as safety issue: No ]
    SCORE risk score

  • Waist circumference [ Time Frame: 1 week, 3 months, 6 months, 12 months ] [ Designated as safety issue: No ]
  • Weight [ Time Frame: 1 week, 3 months, 6 months, 12 months ] [ Designated as safety issue: No ]
  • Blood glucose level [ Time Frame: 1 week, 3 months, 6 months, 12 months ] [ Designated as safety issue: No ]
  • Blood insulin level [ Time Frame: 1 week, 3 months, 6 months, 12 months ] [ Designated as safety issue: No ]
  • HbA1C [ Time Frame: 3 months, 6 months, 12 months ] [ Designated as safety issue: No ]
    Longterm parameter for plasma glucose concentration.

  • Blood creatinine level [ Time Frame: 1 week, 3 months, 6 months, 12 months ] [ Designated as safety issue: No ]
  • Total cholesterol [ Time Frame: 1 week, 3 months, 6 months, 12 months ] [ Designated as safety issue: No ]
  • LDL cholesterol [ Time Frame: 1 week, 3 months, 6 months, 12 months ] [ Designated as safety issue: No ]
  • HDL cholesterol [ Time Frame: 1 week, 3 months, 6 months, 12 months ] [ Designated as safety issue: No ]
  • Medication use [ Time Frame: 1 week, 3 months, 6 months, 12 months ] [ Designated as safety issue: No ]
  • HADS [ Time Frame: 1 week, 3 months, 6 months, 12 months ] [ Designated as safety issue: No ]
    Hospital Anxiety and Depression Scale

  • POMS [ Time Frame: 1 week, 3 months, 6 months, 12 months ] [ Designated as safety issue: No ]
    Profile of Mood States

  • CPSS [ Time Frame: 3 months, 6 months, 12 months ] [ Designated as safety issue: No ]
    Cohen Perceived Stress Scale

  • SWE [ Time Frame: 1 week, 3 months, 6 months, 12 months ] [ Designated as safety issue: No ]
    General self-efficacy (Skala zur Allgemeinen Selbstwirksamkeitserwartung)

  • SF-36 [ Time Frame: 3 months, 6 months, 12 months ] [ Designated as safety issue: No ]
    Health-related quality of life

  • MAAS [ Time Frame: 3 months, 6 months, 12 months ] [ Designated as safety issue: No ]
    Mindfulness Attention Awareness Scale

  • SCS [ Time Frame: 1 week, 3 months, 6 months, 12 months ] [ Designated as safety issue: No ]
    Self-Compassion Scale

  • Lifestyle questionnaire [ Time Frame: 3 months, 6 months, 12 months ] [ Designated as safety issue: No ]
    Questionnaire on physical activity, stress management, diet

  • Hair steroid analysis [ Time Frame: 6 months, 12 months ] [ Designated as safety issue: No ]
    Assessment of long-term glucocorticoid levels in scalp hair.

  • Bioelectrical impedance analysis [ Time Frame: 1 week, 3 months, 6 months, 12 months ] [ Designated as safety issue: No ]
    Method for estimating body composition (body fat).

  • Waist/hip ratio [ Time Frame: 1 week, 3 months, 6 months, 12 months ] [ Designated as safety issue: No ]
  • Immunophenotyping [ Time Frame: 1 week, 3 months, 6 months, 12 months ] [ Designated as safety issue: No ]
    Assessment of membrane protein expression in PBMCs.

  • Intestinal microbiota [ Time Frame: 1 week, 3 months, 6 months, 12 months ] [ Designated as safety issue: No ]
    Characterization of gut microbiota.

  • Metabolomics [ Time Frame: 1 week, 3 months, 6 months, 12 months ] [ Designated as safety issue: No ]
    Assessment of small-molecule metabolite profiles from capillary blood

  • Gene expression profiling [ Time Frame: 1 week, 3 months ] [ Designated as safety issue: No ]
    Assessment of gene expression profiles from PBMCs.

  • Interleukin- 6 [ Time Frame: 1 week, 3 months, 6 months, 12 months ] [ Designated as safety issue: No ]
  • CRP [ Time Frame: 1 week, 3 months, 6 months, 12 months ] [ Designated as safety issue: No ]
  • Uric acid [ Time Frame: 1 week, 3 months, 6 months, 12 months ] [ Designated as safety issue: No ]
  • Insulin-like growth factor (IGF-1) [ Time Frame: 1 week, 3 months, 6 months, 12 months ] [ Designated as safety issue: No ]
  • Safety [ Time Frame: 1 week, 3 months, 6 months, 12 months ] [ Designated as safety issue: Yes ]
    Adverse events

  • Framingham-Score [ Time Frame: 1 week, 3 months, 6 months, 12 months ] [ Designated as safety issue: No ]
  • JBS3-Score [ Time Frame: 1 week, 3 months, 6 months, 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 142
Study Start Date: April 2014
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: December 2014 (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

Ages Eligible for Study:   25 Years to 75 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02099968

Locations
Germany
Immanuel Hospital Berlin, Department of Internal and Complementary Medicine Recruiting
Berlin, Germany, 45276
Contact: Christoph D Hohmann       christoph.hohmann@charite.de   
Contact: Nico Steckhan       nico.steckhan@charite.de   
Principal Investigator: Andreas Michalsen, MD         
Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen Recruiting
Essen, Germany, 45276
Contact: Holger Cramer, PhD       h.cramer@kliniken-essen-mitte.de   
Contact: Kyung-Eun Choi, PhD       k.choi@kliniken-essen-mitte.de   
Principal Investigator: Gustav J Dobos, MD         
Sponsors and Collaborators
Universität Duisburg-Essen
Kliniken Essen-Mitte
Immanuel Hospital Berlin, Berlin, Germany
Charité University Medical Center, Berlin, Germany
University of Witten/Herdecke
  More Information

No publications provided

Responsible Party: Gustav Dobos, Head of Department, Universität Duisburg-Essen
ClinicalTrials.gov Identifier: NCT02099968     History of Changes
Other Study ID Numbers: CORONA
Study First Received: March 26, 2014
Last Updated: April 9, 2014
Health Authority: Germany: Ethics Commission

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

ClinicalTrials.gov processed this record on July 22, 2014