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| Name | Class |
|---|---|
| Kliniken Essen-Mitte | OTHER |
| Immanuel Hospital, Berlin, Germany | OTHER |
| Charite University, Berlin, Germany | OTHER |
| University of Witten/Herdecke |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Comprehensive Lifestyle Modification | Experimental |
| |
| Standard Lifestyle Modification / modified DASH | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comprehensive Lifestyle Modification | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Systolic blood pressure | 24-hour ambulatory blood pressure | 3 months |
| HOMA Index | Homeostatic Model Assessment | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure | 24-hour ambulatory blood pressure | 3 months, 6 months, 12 months |
| Blood pressure | Sphygmomanometer | 1 week, 3 months, 6 months, 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Immanuel Hospital Berlin, Department of Internal and Complementary Medicine | Berlin | 45276 | Germany | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33785752 | Derived | 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. |
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| OTHER |
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| Standard Lifestyle Modification / modified DASH | Behavioral |
|
|
| Pulse wave velocity | Pulse wave velocity (PWV) is a measure of arterial stiffness | 3 months, 6 months, 12 months |
| PROCAM | PROCAM risk score | 1 week, 3 months, 6 months, 12 months |
| SCORE | SCORE risk score | 1 week, 3 months, 6 months, 12 months |
| Waist circumference | 1 week, 3 months, 6 months, 12 months |
| Weight | 1 week, 3 months, 6 months, 12 months |
| Blood glucose level | 1 week, 3 months, 6 months, 12 months |
| Blood insulin level | 1 week, 3 months, 6 months, 12 months |
| HbA1C | Longterm parameter for plasma glucose concentration. | 3 months, 6 months, 12 months |
| Blood creatinine level | 1 week, 3 months, 6 months, 12 months |
| Total cholesterol | 1 week, 3 months, 6 months, 12 months |
| LDL cholesterol | 1 week, 3 months, 6 months, 12 months |
| HDL cholesterol | 1 week, 3 months, 6 months, 12 months |
| Medication use | 1 week, 3 months, 6 months, 12 months |
| HADS | Hospital Anxiety and Depression Scale | 1 week, 3 months, 6 months, 12 months |
| POMS | Profile of Mood States | 1 week, 3 months, 6 months, 12 months |
| CPSS | Cohen Perceived Stress Scale | 3 months, 6 months, 12 months |
| SWE | General self-efficacy (Skala zur Allgemeinen Selbstwirksamkeitserwartung) | 1 week, 3 months, 6 months, 12 months |
| SF-36 | Health-related quality of life | 3 months, 6 months, 12 months |
| MAAS | Mindfulness Attention Awareness Scale | 3 months, 6 months, 12 months |
| SCS | Self-Compassion Scale | 1 week, 3 months, 6 months, 12 months |
| Lifestyle questionnaire | Questionnaire on physical activity, stress management, diet | 3 months, 6 months, 12 months |
| Hair steroid analysis | Assessment of long-term glucocorticoid levels in scalp hair. | 6 months, 12 months |
| Bioelectrical impedance analysis | Method for estimating body composition (body fat). | 1 week, 3 months, 6 months, 12 months |
| Waist/hip ratio | 1 week, 3 months, 6 months, 12 months |
| Immunophenotyping | Assessment of immunological subsets in PBMCs | 1 week, 3 months, 6 months |
| Intestinal microbiota | Characterization of gut microbiota. | 1 week, 3 months, 6 months |
| Metabolomics | Assessment of small-molecule metabolite profiles from capillary blood | 1 week, 3 months |
| Gene expression profiling | Assessment of gene expression profiles from PBMCs. | 1 week, 3 months |
| Interleukin- 6 | 1 week, 3 months, 6 months, 12 months |
| CRP | 1 week, 3 months, 6 months, 12 months |
| Uric acid | 1 week, 3 months, 6 months, 12 months |
| Insulin-like growth factor (IGF-1) | 1 week, 3 months, 6 months, 12 months |
| Adverse events | Adverse events | 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 |
| Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen |
| Essen |
| 45276 |
| Germany |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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