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

• Sponsor: Universität Duisburg-Essen (Other)
• Overall Status: Completed
• CT.gov ID: NCT02099968
• Collaborator: Kliniken Essen-Mitte (Other), Immanuel Hospital Berlin, Berlin, Germany (Other), Charite University, Berlin, Germany (Other), University of Witten/Herdecke (Other)
• Enrollment: 145
• Locations: 2
• Arms: 2
• Duration (Months): 20
• Patients Per Site: 72.5
• Patients Per Site Per Month: 3.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension; Metabolic Syndrome	Behavioral: Comprehensive Lifestyle Modification; Behavioral: Standard Lifestyle Modification / modified DASH	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 145 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (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
• Study Start Date: Apr 1, 2014
• Actual Primary Completion Date: Mar 1, 2015
• Actual Study Completion Date: Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Comprehensive Lifestyle Modification	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
Active Comparator: Standard Lifestyle Modification / modified DASH	Behavioral: Standard Lifestyle Modification / modified DASH; Modified DASH (vegetarian focused, plant-based, low-salt) Aerobic exercise Stress reduction techniques: progressive muscle relaxation

Outcome Measures

Primary Outcome Measures

1. Systolic blood pressure [3 months]

   24-hour ambulatory blood pressure

2. HOMA Index [3 months]

   Homeostatic Model Assessment

Secondary Outcome Measures

1. Blood pressure [3 months, 6 months, 12 months]

   24-hour ambulatory blood pressure

2. Blood pressure [1 week, 3 months, 6 months, 12 months]

   Sphygmomanometer

3. Pulse wave velocity [3 months, 6 months, 12 months]

   Pulse wave velocity (PWV) is a measure of arterial stiffness

4. PROCAM [1 week, 3 months, 6 months, 12 months]

   PROCAM risk score

5. SCORE [1 week, 3 months, 6 months, 12 months]

   SCORE risk score

6. Waist circumference [1 week, 3 months, 6 months, 12 months]

7. Weight [1 week, 3 months, 6 months, 12 months]

8. Blood glucose level [1 week, 3 months, 6 months, 12 months]

9. Blood insulin level [1 week, 3 months, 6 months, 12 months]

10. HbA1C [3 months, 6 months, 12 months]

    Longterm parameter for plasma glucose concentration.

11. Blood creatinine level [1 week, 3 months, 6 months, 12 months]

12. Total cholesterol [1 week, 3 months, 6 months, 12 months]

13. LDL cholesterol [1 week, 3 months, 6 months, 12 months]

14. HDL cholesterol [1 week, 3 months, 6 months, 12 months]

15. Medication use [1 week, 3 months, 6 months, 12 months]

16. HADS [1 week, 3 months, 6 months, 12 months]

    Hospital Anxiety and Depression Scale

17. POMS [1 week, 3 months, 6 months, 12 months]

    Profile of Mood States

18. CPSS [3 months, 6 months, 12 months]

    Cohen Perceived Stress Scale

19. SWE [1 week, 3 months, 6 months, 12 months]

    General self-efficacy (Skala zur Allgemeinen Selbstwirksamkeitserwartung)

20. SF-36 [3 months, 6 months, 12 months]

    Health-related quality of life

21. MAAS [3 months, 6 months, 12 months]

    Mindfulness Attention Awareness Scale

22. SCS [1 week, 3 months, 6 months, 12 months]

    Self-Compassion Scale

23. Lifestyle questionnaire [3 months, 6 months, 12 months]

    Questionnaire on physical activity, stress management, diet

24. Hair steroid analysis [6 months, 12 months]

    Assessment of long-term glucocorticoid levels in scalp hair.

25. Bioelectrical impedance analysis [1 week, 3 months, 6 months, 12 months]

    Method for estimating body composition (body fat).

26. Waist/hip ratio [1 week, 3 months, 6 months, 12 months]

27. Immunophenotyping [1 week, 3 months, 6 months]

    Assessment of immunological subsets in PBMCs

28. Intestinal microbiota [1 week, 3 months, 6 months]

    Characterization of gut microbiota.

29. Metabolomics [1 week, 3 months]

    Assessment of small-molecule metabolite profiles from capillary blood

30. Gene expression profiling [1 week, 3 months]

    Assessment of gene expression profiles from PBMCs.

31. Interleukin- 6 [1 week, 3 months, 6 months, 12 months]

32. CRP [1 week, 3 months, 6 months, 12 months]

33. Uric acid [1 week, 3 months, 6 months, 12 months]

34. Insulin-like growth factor (IGF-1) [1 week, 3 months, 6 months, 12 months]

35. Adverse events [1 week, 3 months, 6 months, 12 months]

    Adverse events

36. Framingham-Score [1 week, 3 months, 6 months, 12 months]

37. JBS3-Score [1 week, 3 months, 6 months, 12 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 25 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Immanuel Hospital Berlin, Department of Internal and Complementary Medicine	Berlin		Germany	45276
2	Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen	Essen		Germany	45276

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gustav Dobos, Head of Department, Universität Duisburg-Essen
• ClinicalTrials.gov Identifier: NCT02099968
• Other Study ID Numbers: CORONA
• First Posted: Mar 31, 2014
• Last Update Posted: Jul 10, 2019
• Last Verified: Jul 1, 2019

• Additional relevant MeSH terms: Hypertension; Metabolic Syndrome; Syndrome

Study Results

No Results Posted as of Jul 10, 2019