Clinical trial NCT02099968: 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
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Metabolic Syndrome
Lead sponsor: Universität Duisburg-Essen
Sponsor class: OTHER
Collaborators: name: Kliniken Essen-Mitte
name: Immanuel Hospital Berlin, Berlin, Germany
name: Charite University, Berlin, Germany
name: University of Witten/Herdecke
First posted: 2014-03-31
Enrollment: 145
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Systolic blood pressure
timeFrame: 3 months
measure: HOMA Index
timeFrame: 3 months
Secondary outcomes:
measure: Blood pressure
timeFrame: 3 months, 6 months, 12 months
measure: Blood pressure
timeFrame: 1 week, 3 months, 6 months, 12 months
measure: Pulse wave velocity
timeFrame: 3 months, 6 months, 12 months
measure: PROCAM
timeFrame: 1 week, 3 months, 6 months, 12 months
measure: SCORE
timeFrame: 1 week, 3 months, 6 months, 12 months
measure: Waist circumference
timeFrame: 1 week, 3 months, 6 months, 12 months
measure: Weight
timeFrame: 1 week, 3 months, 6 months, 12 months
measure: Blood glucose level
timeFrame: 1 week, 3 months, 6 months, 12 months
measure: Blood insulin level
timeFrame: 1 week, 3 months, 6 months, 12 months
measure: HbA1C
timeFrame: 3 months, 6 months, 12 months
measure: Blood creatinine level
timeFrame: 1 week, 3 months, 6 months, 12 months
measure: Total cholesterol
timeFrame: 1 week, 3 months, 6 months, 12 months
measure: LDL cholesterol
timeFrame: 1 week, 3 months, 6 months, 12 months
measure: HDL cholesterol
timeFrame: 1 week, 3 months, 6 months, 12 months
measure: Medication use
timeFrame: 1 week, 3 months, 6 months, 12 months
measure: HADS
timeFrame: 1 week, 3 months, 6 months, 12 months
measure: POMS
timeFrame: 1 week, 3 months, 6 months, 12 months
measure: CPSS
timeFrame: 3 months, 6 months, 12 months
measure: SWE
timeFrame: 1 week, 3 months, 6 months, 12 months
measure: SF-36
timeFrame: 3 months, 6 months, 12 months
measure: MAAS
timeFrame: 3 months, 6 months, 12 months
measure: SCS
timeFrame: 1 week, 3 months, 6 months, 12 months
measure: Lifestyle questionnaire
timeFrame: 3 months, 6 months, 12 months
measure: Hair steroid analysis
timeFrame: 6 months, 12 months
measure: Bioelectrical impedance analysis
timeFrame: 1 week, 3 months, 6 months, 12 months
measure: Waist/hip ratio
timeFrame: 1 week, 3 months, 6 months, 12 months
measure: Immunophenotyping
timeFrame: 1 week, 3 months, 6 months
measure: Intestinal microbiota
timeFrame: 1 week, 3 months, 6 months
measure: Metabolomics
timeFrame: 1 week, 3 months
measure: Gene expression profiling
timeFrame: 1 week, 3 months
measure: Interleukin- 6
timeFrame: 1 week, 3 months, 6 months, 12 months
measure: CRP
timeFrame: 1 week, 3 months, 6 months, 12 months
measure: Uric acid
timeFrame: 1 week, 3 months, 6 months, 12 months
measure: Insulin-like growth factor (IGF-1)
timeFrame: 1 week, 3 months, 6 months, 12 months
measure: Adverse events
timeFrame: 1 week, 3 months, 6 months, 12 months
measure: Framingham-Score
timeFrame: 1 week, 3 months, 6 months, 12 months
measure: JBS3-Score
timeFrame: 1 week, 3 months, 6 months, 12 months
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Immanuel Hospital Berlin, Department of Internal and Complementary Medicine
city: Essen
country: Germany
facility: Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen
Study officials:
References:
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.