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

Hypertension Clinical Trial

Official title:

Intensivierte Ernährungs- Und Lebensstilmodifikation Bei Patienten Mit Bluthochdruck Und Kardiometabolischer Risikokonstellation. Eine Zweizentrische Randomisiert-kontrollierte Interventionsstudie über 6 Monate

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02099968
• Other study ID #: CORONA
• Status: Completed
• Phase: N/A
• Start date: April 2014
• Est. completion date: December 2015

Study information

• Verified date: July 2019
• Source: Universität Duisburg-Essen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: December 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Metabolic Syndrome
• Syndrome

Intervention

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
• Standard Lifestyle Modification / modified DASH
Modified DASH (vegetarian focused, plant-based, low-salt) Aerobic exercise Stress reduction techniques: progressive muscle relaxation

Locations

Country	Name	City	State
Germany	Immanuel Hospital Berlin, Department of Internal and Complementary Medicine	Berlin
Germany	Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen	Essen

Sponsors (5)

Lead Sponsor	Collaborator
Universität Duisburg-Essen	Charite University, Berlin, Germany, Immanuel Hospital Berlin, Berlin, Germany, Kliniken Essen-Mitte, University of Witten/Herdecke

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Systolic blood pressure	24-hour ambulatory blood pressure	3 months
Primary	HOMA Index	Homeostatic Model Assessment	3 months
Secondary	Blood pressure	24-hour ambulatory blood pressure	3 months, 6 months, 12 months
Secondary	Blood pressure	Sphygmomanometer	1 week, 3 months, 6 months, 12 months
Secondary	Pulse wave velocity	Pulse wave velocity (PWV) is a measure of arterial stiffness	3 months, 6 months, 12 months
Secondary	PROCAM	PROCAM risk score	1 week, 3 months, 6 months, 12 months
Secondary	SCORE	SCORE risk score	1 week, 3 months, 6 months, 12 months
Secondary	Waist circumference		1 week, 3 months, 6 months, 12 months
Secondary	Weight		1 week, 3 months, 6 months, 12 months
Secondary	Blood glucose level		1 week, 3 months, 6 months, 12 months
Secondary	Blood insulin level		1 week, 3 months, 6 months, 12 months
Secondary	HbA1C	Longterm parameter for plasma glucose concentration.	3 months, 6 months, 12 months
Secondary	Blood creatinine level		1 week, 3 months, 6 months, 12 months
Secondary	Total cholesterol		1 week, 3 months, 6 months, 12 months
Secondary	LDL cholesterol		1 week, 3 months, 6 months, 12 months
Secondary	HDL cholesterol		1 week, 3 months, 6 months, 12 months
Secondary	Medication use		1 week, 3 months, 6 months, 12 months
Secondary	HADS	Hospital Anxiety and Depression Scale	1 week, 3 months, 6 months, 12 months
Secondary	POMS	Profile of Mood States	1 week, 3 months, 6 months, 12 months
Secondary	CPSS	Cohen Perceived Stress Scale	3 months, 6 months, 12 months
Secondary	SWE	General self-efficacy (Skala zur Allgemeinen Selbstwirksamkeitserwartung)	1 week, 3 months, 6 months, 12 months
Secondary	SF-36	Health-related quality of life	3 months, 6 months, 12 months
Secondary	MAAS	Mindfulness Attention Awareness Scale	3 months, 6 months, 12 months
Secondary	SCS	Self-Compassion Scale	1 week, 3 months, 6 months, 12 months
Secondary	Lifestyle questionnaire	Questionnaire on physical activity, stress management, diet	3 months, 6 months, 12 months
Secondary	Hair steroid analysis	Assessment of long-term glucocorticoid levels in scalp hair.	6 months, 12 months
Secondary	Bioelectrical impedance analysis	Method for estimating body composition (body fat).	1 week, 3 months, 6 months, 12 months
Secondary	Waist/hip ratio		1 week, 3 months, 6 months, 12 months
Secondary	Immunophenotyping	Assessment of immunological subsets in PBMCs	1 week, 3 months, 6 months
Secondary	Intestinal microbiota	Characterization of gut microbiota.	1 week, 3 months, 6 months
Secondary	Metabolomics	Assessment of small-molecule metabolite profiles from capillary blood	1 week, 3 months
Secondary	Gene expression profiling	Assessment of gene expression profiles from PBMCs.	1 week, 3 months
Secondary	Interleukin- 6		1 week, 3 months, 6 months, 12 months
Secondary	CRP		1 week, 3 months, 6 months, 12 months
Secondary	Uric acid		1 week, 3 months, 6 months, 12 months
Secondary	Insulin-like growth factor (IGF-1)		1 week, 3 months, 6 months, 12 months
Secondary	Adverse events	Adverse events	1 week, 3 months, 6 months, 12 months
Secondary	Framingham-Score		1 week, 3 months, 6 months, 12 months
Secondary	JBS3-Score		1 week, 3 months, 6 months, 12 months