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

Not Applicable

Completed

• Conditions: Hypertension; Metabolic Syndrome
• Interventions: Behavioral: Comprehensive Lifestyle Modification; Behavioral: Standard Lifestyle Modification / modified DASH

• Registration Number: NCT02099968
• Lead Sponsor: Universität Duisburg-Essen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-03-26
• Study First Submitted QC: 2014-03-26
• Study First Posted: 2014-03-31
• Study Start: 2014-04
• Primary Completion: 2015-03
• Study Completion: 2015-12
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-08
• Last Update Posted: 2019-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 145

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Comprehensive Lifestyle Modification	Comprehensive Lifestyle Modification	-
Standard Lifestyle Modification / modified DASH	Standard Lifestyle Modification / modified DASH	-

Primary Outcome Measures

Name	Time	Method
HOMA Index	3 months	Homeostatic Model Assessment
Systolic blood pressure	3 months	24-hour ambulatory blood pressure

Secondary Outcome Measures

Name	Time	Method
Metabolomics	1 week, 3 months	Assessment of small-molecule metabolite profiles from capillary blood
Adverse events	1 week, 3 months, 6 months, 12 months	Adverse events
LDL cholesterol	1 week, 3 months, 6 months, 12 months
Medication use	1 week, 3 months, 6 months, 12 months
CRP	1 week, 3 months, 6 months, 12 months
Framingham-Score	1 week, 3 months, 6 months, 12 months
JBS3-Score	1 week, 3 months, 6 months, 12 months
SCORE	1 week, 3 months, 6 months, 12 months	SCORE risk score
Blood creatinine level	1 week, 3 months, 6 months, 12 months
HDL cholesterol	1 week, 3 months, 6 months, 12 months
POMS	1 week, 3 months, 6 months, 12 months	Profile of Mood States
SWE	1 week, 3 months, 6 months, 12 months	General self-efficacy (Skala zur Allgemeinen Selbstwirksamkeitserwartung)
SCS	1 week, 3 months, 6 months, 12 months	Self-Compassion Scale
Waist circumference	1 week, 3 months, 6 months, 12 months
Blood glucose level	1 week, 3 months, 6 months, 12 months
HADS	1 week, 3 months, 6 months, 12 months	Hospital Anxiety and Depression Scale
PROCAM	1 week, 3 months, 6 months, 12 months	PROCAM risk score
Blood insulin level	1 week, 3 months, 6 months, 12 months
HbA1C	3 months, 6 months, 12 months	Longterm parameter for plasma glucose concentration.
MAAS	3 months, 6 months, 12 months	Mindfulness Attention Awareness Scale
Pulse wave velocity	3 months, 6 months, 12 months	Pulse wave velocity (PWV) is a measure of arterial stiffness
SF-36	3 months, 6 months, 12 months	Health-related quality of life
Bioelectrical impedance analysis	1 week, 3 months, 6 months, 12 months	Method for estimating body composition (body fat).
Immunophenotyping	1 week, 3 months, 6 months	Assessment of immunological subsets in PBMCs
Gene expression profiling	1 week, 3 months	Assessment of gene expression profiles from PBMCs.
Blood pressure	1 week, 3 months, 6 months, 12 months	Sphygmomanometer
Weight	1 week, 3 months, 6 months, 12 months
Total cholesterol	1 week, 3 months, 6 months, 12 months
CPSS	3 months, 6 months, 12 months	Cohen Perceived Stress Scale
Lifestyle questionnaire	3 months, 6 months, 12 months	Questionnaire on physical activity, stress management, diet
Hair steroid analysis	6 months, 12 months	Assessment of long-term glucocorticoid levels in scalp hair.
Waist/hip ratio	1 week, 3 months, 6 months, 12 months
Insulin-like growth factor (IGF-1)	1 week, 3 months, 6 months, 12 months
Intestinal microbiota	1 week, 3 months, 6 months	Characterization of gut microbiota.
Interleukin- 6	1 week, 3 months, 6 months, 12 months
Uric acid	1 week, 3 months, 6 months, 12 months

Trial Locations

Locations (2)

Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen; 🇩🇪 Essen, Germany

Immanuel Hospital Berlin, Department of Internal and Complementary Medicine; 🇩🇪 Berlin, Germany