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| ID | Type | Description | Link |
|---|---|---|---|
| DRKS00015140 | Registry Identifier | German Clinical Trials Register |
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| Name | Class |
|---|---|
| Technical University of Munich | OTHER |
| privates Institut für angewandte Versorgungsforschung GmbH | UNKNOWN |
| IDS Diagnostic Systems AG | UNKNOWN |
| Federal Joint Committee |
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Chronic ischemic heart disease and diabetes mellitus type II have one of the highest morbidity and mortality rates. Especially in the presence of both diseases, these risks increase exponentially. The aim of this program is to reduce cardiovascular risk factors by promoting individual health literacy and a healthy lifestyle, thereby improving metabolism and reducing the progress of the disease as well as mortality.
Patients will receive individual exercise prescriptions and nutritional recommendations. This lifestyle intervention is accompanied by step counters, heart rate sensors, blood glucose meters and smartphones to allow regional implementation in different areas in Germany. In total, 1500 patients with diabetes mellitus type II and chronic ischemic heart disease will participate in the trial.
The project examines whether the intervention positively affects metabolic health and lifestyle behaviors, increases health literacy, and reduces cardiovascular events of these high risk patients. Furthermore, the effectiveness of the intervention will be compared between urban and rural areas.
Chronic ischemic heart disease and diabetes mellitus type II have one of the highest morbidity and mortality rates. Especially in the presence of both diseases, these risks increase exponentially. The combined endpoint of death and myocardial infarction reaches up to 30% within four years. A lifestyle intervention with exercise training and dietary change can reduce the mortality by 20-30% and is a class-I indication in the current guidelines of the European Association of Preventive Cardiology (EAPC). Nevertheless, the implementation of lifestyle interventions in the population is insufficient.
This prospective randomized controlled trial examines whether a structured, individual and telemedicine-supported lifestyle intervention improves health literacy and reduces cardiovascular risk factors compared to a guideline-based recommendation (usual care). Furthermore, the effectiveness of the intervention will be compared between urban and rural areas.
In total, 1500 patients with diabetes mellitus type II and chronic ischemic heart disease will participate in the trial. After randomization (1:1), the 750 patients of the intervention group will receive individual exercise prescriptions and nutritional recommendations based on a maximum exercise stress test and a multi-day nutrition protocol. The intervention is accompanied by pedometers, heart rate sensors, blood glucose meters and smartphones as well as regular oral and written feedback.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| lifestyle intervention | Experimental | Telemedicine-supported lifestyle intervention trough individual structured exercise training (endurance and strength training), increase in daily physical activity, and individual nutritional recommendations |
|
| usual care | Active Comparator | general exercise and nutritional recommendations according to current guidelines |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lifestyle intervention | Behavioral | intervention phase 1 (baseline - month 6): Patients receive an individual exercise plan, nutritional recommendations and advices to increase daily activity. The intervention is accompanied by regular oral and written feedback. intervention phase 2 (month 6 - month 12): Patients receive an individual exercise plan, nutritional recommendations and advices to increase daily activity without additional oral or written feedback. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c | measured in percent (%) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c | measured in percent (%) | 12 months |
| Change in health literacy | European Health Literacy Survey Questionnaire (HLS-EU-Q16) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martin Halle, Prof. Dr. med. | Klinikum rechts der Isar Technische Universität München | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital: Rheinisch-Westfälische Technische Hochschule Aachen | Aachen | Germany | ||||
| University Hospital: Charité - Universitätsmedizin Berlin |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39920395 | Derived | Mueller S, Dinges SMT, Gass F, Fegers-Wustrow I, Treitschke J, von Korn P, Boscheri A, Krotz J, Freigang F, Dubois C, Winzer EB, Linke A, Edelmann F, Feuerstein A, Wolfram O, Schafer K, Verket M, Wolfarth B, Dorr M, Wachter R, Hackenberg B, Rust S, Nebling T, Amelung V, Halle M. Telemedicine-supported lifestyle intervention for glycemic control in patients with CHD and T2DM: multicenter, randomized controlled trial. Nat Med. 2025 Apr;31(4):1203-1213. doi: 10.1038/s41591-025-03498-w. Epub 2025 Feb 7. | |
| 35953083 |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D006331 | Heart Diseases |
| D009043 | Motor Activity |
| D003324 | Coronary Artery Disease |
| D003327 | Coronary Disease |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| OTHER_GOV |
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|
| usual care | Behavioral | Recommendation for lifestyle intervention at baseline and after 6 months (e.g. salt reduction, restricted alcohol consumption and smoking cessation, 10,000 steps/day, 150 minutes/week moderate intensity exercise) |
|
| 6 and 12 months |
| Change in daily physical activity | International Physical Activity Questionnaire (IPAQ) | 6 and 12 months |
| Change in average steps per day | 7-day average of steps/day measured by pedometers | 6 and 12 months |
| Change in eating behavior | Fragebogen zum Essverhalten (FEV; German questionnaire on eating behavior) | 6 and 12 months |
| Change in quality of life | Short form health survey (SF-36) | 6 and 12 months |
| Change of medical care expenses | routine data of health insurance company | 6 and 12 months |
| Change in weight | measured in kilograms (kg) | 6 and 12 months |
| Change in waist circumference | measured in centimeters (cm) | 6 and 12 months |
| Change in LDL-cholesterol concentrations | measured in milligram/deciliter (mg/dL) | 6 and 12 months |
| Change in HDL-cholesterol concentrations | measured in milligram/deciliter (mg/dL) | 6 and 12 months |
| Change in triglyceride concentrations | measured in milligram/deciliter (mg/dL) | 6 and 12 months |
| Change in systolic blood pressure | measured in millimeters of mercury (mmHG) | 6 and 12 months |
| Change in diastolic blood pressure | measured in millimeters of mercury (mmHG) | 6 and 12 months |
| Number of the combined endpoint "4P-MACE" | cardiovascular deaths, non-fatal stroke, non-fatal myocardial infarction, hospitalization due to angina pectoris | 6 and 12 months |
| Berlin |
| Germany |
| University Hospital: Herzzentrum Dresden | Dresden | Germany |
| University Hospital: Universitäts-Herzzentrum Freiburg - Bad Krozingen | Freiburg im Breisgau | Germany |
| University Hospital: Universitätsmedizin Greifswald | Greifswald | Germany |
| Doctor's Practice: Dr. Rüdell | Kassel | Germany |
| University Hospital: Klinik und Poliklinik für Kardiologie - Universitätsklinikum Leipzig | Leipzig | 04103 | Germany |
| University Hospital: Magdeburg | Magdeburg | Germany |
| University Hospital: Klinikum rechts der Isar, Technische Universität München | Munich | Germany |
| Doctor's Practice: Prof. Dr. Jacob und Dr. Jacob | Villingen-Schwenningen | Germany |
| Derived |
| Dinges SM, Krotz J, Gass F, Treitschke J, Fegers-Wustrow I, Geisberger M, Esefeld K, von Korn P, Duvinage A, Edelmann F, Wolfram O, Brandts J, Winzer EB, Wolfarth B, Freigang F, Neubauer S, Nebling T, Hackenberg B, Amelung V, Mueller S, Halle M. Cardiovascular risk factors, exercise capacity and health literacy in patients with chronic ischaemic heart disease and type 2 diabetes mellitus in Germany: Baseline characteristics of the Lifestyle Intervention in Chronic Ischaemic Heart Disease and Type 2 Diabetes study. Diab Vasc Dis Res. 2022 Jul-Aug;19(4):14791641221113781. doi: 10.1177/14791641221113781. |
| 33558354 | Derived | von Korn P, Sydow H, Neubauer S, Duvinage A, Mocek A, Dinges S, Hackenberg B, Weichenberger M, Schoenfeld J, Amelung V, Mueller S, Halle M. Lifestyle Intervention in Chronic Ischaemic Heart Disease and Type 2 Diabetes (the LeIKD study): study protocol of a prospective, multicentre, randomised, controlled trial. BMJ Open. 2021 Feb 8;11(2):e042818. doi: 10.1136/bmjopen-2020-042818. |
| D004700 | Endocrine System Diseases |
| D002318 | Cardiovascular Diseases |
| D001519 | Behavior |
| D017202 | Myocardial Ischemia |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |