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

Primary Purpose

Hypertension, Metabolic Syndrome

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Comprehensive Lifestyle Modification
Standard Lifestyle Modification / modified DASH
Sponsored by
Universität Duisburg-Essen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

25 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Immanuel Hospital Berlin, Department of Internal and Complementary Medicine
  • Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Comprehensive Lifestyle Modification

Standard Lifestyle Modification / modified DASH

Arm Description

Outcomes

Primary Outcome Measures

Systolic blood pressure
24-hour ambulatory blood pressure
HOMA Index
Homeostatic Model Assessment

Secondary Outcome Measures

Blood pressure
24-hour ambulatory blood pressure
Blood pressure
Sphygmomanometer
Pulse wave velocity
Pulse wave velocity (PWV) is a measure of arterial stiffness
PROCAM
PROCAM risk score
SCORE
SCORE risk score
Waist circumference
Weight
Blood glucose level
Blood insulin level
HbA1C
Longterm parameter for plasma glucose concentration.
Blood creatinine level
Total cholesterol
LDL cholesterol
HDL cholesterol
Medication use
HADS
Hospital Anxiety and Depression Scale
POMS
Profile of Mood States
CPSS
Cohen Perceived Stress Scale
SWE
General self-efficacy (Skala zur Allgemeinen Selbstwirksamkeitserwartung)
SF-36
Health-related quality of life
MAAS
Mindfulness Attention Awareness Scale
SCS
Self-Compassion Scale
Lifestyle questionnaire
Questionnaire on physical activity, stress management, diet
Hair steroid analysis
Assessment of long-term glucocorticoid levels in scalp hair.
Bioelectrical impedance analysis
Method for estimating body composition (body fat).
Waist/hip ratio
Immunophenotyping
Assessment of immunological subsets in PBMCs
Intestinal microbiota
Characterization of gut microbiota.
Metabolomics
Assessment of small-molecule metabolite profiles from capillary blood
Gene expression profiling
Assessment of gene expression profiles from PBMCs.
Interleukin- 6
CRP
Uric acid
Insulin-like growth factor (IGF-1)
Adverse events
Adverse events
Framingham-Score
JBS3-Score

Full Information

First Posted
March 26, 2014
Last Updated
July 8, 2019
Sponsor
Universität Duisburg-Essen
Collaborators
Kliniken Essen-Mitte, Immanuel Hospital Berlin, Berlin, Germany, Charite University, Berlin, Germany, University of Witten/Herdecke
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1. Study Identification

Unique Protocol Identification Number
NCT02099968
Brief Title
Comprehensive Lifestyle Modification for Patients With Hypertension and Metabolic Syndrome: a Multicenter Randomized Controlled Trial
Official Title
Intensivierte Ernährungs- Und Lebensstilmodifikation Bei Patienten Mit Bluthochdruck Und Kardiometabolischer Risikokonstellation. Eine Zweizentrische Randomisiert-kontrollierte Interventionsstudie über 6 Monate
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universität Duisburg-Essen
Collaborators
Kliniken Essen-Mitte, Immanuel Hospital Berlin, Berlin, Germany, Charite University, Berlin, Germany, University of Witten/Herdecke

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Metabolic Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
145 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Comprehensive Lifestyle Modification
Arm Type
Experimental
Arm Title
Standard Lifestyle Modification / modified DASH
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Comprehensive Lifestyle Modification
Intervention Description
Fasting (1st week), followed by: Vegetarian and modified DASH diet (plant-based, low-salt) Aerobic exercise Stress reduction techniques: progressive muscle relaxation, meditation, yoga
Intervention Type
Behavioral
Intervention Name(s)
Standard Lifestyle Modification / modified DASH
Intervention Description
Modified DASH (vegetarian focused, plant-based, low-salt) Aerobic exercise Stress reduction techniques: progressive muscle relaxation
Primary Outcome Measure Information:
Title
Systolic blood pressure
Description
24-hour ambulatory blood pressure
Time Frame
3 months
Title
HOMA Index
Description
Homeostatic Model Assessment
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Blood pressure
Description
24-hour ambulatory blood pressure
Time Frame
3 months, 6 months, 12 months
Title
Blood pressure
Description
Sphygmomanometer
Time Frame
1 week, 3 months, 6 months, 12 months
Title
Pulse wave velocity
Description
Pulse wave velocity (PWV) is a measure of arterial stiffness
Time Frame
3 months, 6 months, 12 months
Title
PROCAM
Description
PROCAM risk score
Time Frame
1 week, 3 months, 6 months, 12 months
Title
SCORE
Description
SCORE risk score
Time Frame
1 week, 3 months, 6 months, 12 months
Title
Waist circumference
Time Frame
1 week, 3 months, 6 months, 12 months
Title
Weight
Time Frame
1 week, 3 months, 6 months, 12 months
Title
Blood glucose level
Time Frame
1 week, 3 months, 6 months, 12 months
Title
Blood insulin level
Time Frame
1 week, 3 months, 6 months, 12 months
Title
HbA1C
Description
Longterm parameter for plasma glucose concentration.
Time Frame
3 months, 6 months, 12 months
Title
Blood creatinine level
Time Frame
1 week, 3 months, 6 months, 12 months
Title
Total cholesterol
Time Frame
1 week, 3 months, 6 months, 12 months
Title
LDL cholesterol
Time Frame
1 week, 3 months, 6 months, 12 months
Title
HDL cholesterol
Time Frame
1 week, 3 months, 6 months, 12 months
Title
Medication use
Time Frame
1 week, 3 months, 6 months, 12 months
Title
HADS
Description
Hospital Anxiety and Depression Scale
Time Frame
1 week, 3 months, 6 months, 12 months
Title
POMS
Description
Profile of Mood States
Time Frame
1 week, 3 months, 6 months, 12 months
Title
CPSS
Description
Cohen Perceived Stress Scale
Time Frame
3 months, 6 months, 12 months
Title
SWE
Description
General self-efficacy (Skala zur Allgemeinen Selbstwirksamkeitserwartung)
Time Frame
1 week, 3 months, 6 months, 12 months
Title
SF-36
Description
Health-related quality of life
Time Frame
3 months, 6 months, 12 months
Title
MAAS
Description
Mindfulness Attention Awareness Scale
Time Frame
3 months, 6 months, 12 months
Title
SCS
Description
Self-Compassion Scale
Time Frame
1 week, 3 months, 6 months, 12 months
Title
Lifestyle questionnaire
Description
Questionnaire on physical activity, stress management, diet
Time Frame
3 months, 6 months, 12 months
Title
Hair steroid analysis
Description
Assessment of long-term glucocorticoid levels in scalp hair.
Time Frame
6 months, 12 months
Title
Bioelectrical impedance analysis
Description
Method for estimating body composition (body fat).
Time Frame
1 week, 3 months, 6 months, 12 months
Title
Waist/hip ratio
Time Frame
1 week, 3 months, 6 months, 12 months
Title
Immunophenotyping
Description
Assessment of immunological subsets in PBMCs
Time Frame
1 week, 3 months, 6 months
Title
Intestinal microbiota
Description
Characterization of gut microbiota.
Time Frame
1 week, 3 months, 6 months
Title
Metabolomics
Description
Assessment of small-molecule metabolite profiles from capillary blood
Time Frame
1 week, 3 months
Title
Gene expression profiling
Description
Assessment of gene expression profiles from PBMCs.
Time Frame
1 week, 3 months
Title
Interleukin- 6
Time Frame
1 week, 3 months, 6 months, 12 months
Title
CRP
Time Frame
1 week, 3 months, 6 months, 12 months
Title
Uric acid
Time Frame
1 week, 3 months, 6 months, 12 months
Title
Insulin-like growth factor (IGF-1)
Time Frame
1 week, 3 months, 6 months, 12 months
Title
Adverse events
Description
Adverse events
Time Frame
1 week, 3 months, 6 months, 12 months
Title
Framingham-Score
Time Frame
1 week, 3 months, 6 months, 12 months
Title
JBS3-Score
Time Frame
1 week, 3 months, 6 months, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Immanuel Hospital Berlin, Department of Internal and Complementary Medicine
City
Berlin
ZIP/Postal Code
45276
Country
Germany
Facility Name
Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen
City
Essen
ZIP/Postal Code
45276
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
33785752
Citation
Maifeld A, Bartolomaeus H, Lober U, Avery EG, Steckhan N, Marko L, Wilck N, Hamad I, Susnjar U, Mahler A, Hohmann C, Chen CY, Cramer H, Dobos G, Lesker TR, Strowig T, Dechend R, Bzdok D, Kleinewietfeld M, Michalsen A, Muller DN, Forslund SK. Fasting alters the gut microbiome reducing blood pressure and body weight in metabolic syndrome patients. Nat Commun. 2021 Mar 30;12(1):1970. doi: 10.1038/s41467-021-22097-0.
Results Reference
derived

Learn more about this trial

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

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