Lifestyle Intervention in Chronic Ischemic Heart Disease and Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

— LeIKD  

Official title:

Lifestyle Intervention in Chronic Ischemic Heart Disease and Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03835923
• Other study ID #: 01NVF17015
• Secondary ID: DRKS00015140
• Status: Completed
• Phase: N/A
• Start date: February 12, 2019
• Est. completion date: April 16, 2021

Study information

• Verified date: November 2021
• Source: Techniker Krankenkasse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 502
• Est. completion date: April 16, 2021
• Est. primary completion date: December 16, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• ischemic heart disease (ICD-10: I20-I25)

• Diabetes mellitus heart disease (ICD-10: E11)

• insured at participating health insurance

• permission to exercise by the study investigator

• written informed consent

Exclusion Criteria:

• Mental and behavioral disorders (ICD-10: F0-F99)

• Heart failure NYHA IV (ICD-10: I50.14)

• Malignant neoplasm (ICD-10: C25, C34, C56, C72, C73, C78, C79, C97)

• Parkinson's disease (ICD-10: G20)

• Alzheimer's disease (ICD-10: G30)

• infantile cerebral palsy (ICD-10: G80)

• chronic kidney disease (ICD-10: N18.4 & N18.5)

• Trisomy 21 (ICD-10: Q90)

• Blindness / visual impairment (ICD-10: H54.0, H54.2, H54.3)

• Hearing loss (ICD-10: H90.0, H90.3, H90.5, H90.6, H90.8)

• Care level 1-5

• Assured in a foreign country

• Inability to exercise or conditions that may interfere with exercise intervention

• No optimal medical treatment within the last 4 weeks

• Not clinically stable within the last 4 weeks

• Participation in another clinical trial

Related Conditions & MeSH terms

• Coronary Artery Disease
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Heart Diseases
• Ischemia
• Ischemic Heart Disease Chronic
• Myocardial Ischemia

Intervention

Behavioral:
• lifestyle intervention
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.
• usual care
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)

Locations

Country	Name	City	State
Germany	University Hospital: Rheinisch-Westfälische Technische Hochschule Aachen	Aachen
Germany	University Hospital: Charité - Universitätsmedizin Berlin	Berlin
Germany	University Hospital: Herzzentrum Dresden	Dresden
Germany	University Hospital: Universitäts-Herzzentrum Freiburg - Bad Krozingen	Freiburg
Germany	University Hospital: Universitätsmedizin Greifswald	Greifswald
Germany	Doctor's Practice: Dr. Rüdell	Kassel
Germany	University Hospital: Klinik und Poliklinik für Kardiologie - Universitätsklinikum Leipzig	Leipzig
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

Sponsors (5)

Lead Sponsor	Collaborator
Techniker Krankenkasse	Federal Joint Committee, IDS Diagnostic Systems AG, privates Institut für angewandte Versorgungsforschung GmbH, Technische Universität München

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c	measured in percent (%)	6 months
Secondary	Change in HbA1c	measured in percent (%)	12 months
Secondary	Change in health literacy	European Health Literacy Survey Questionnaire (HLS-EU-Q16)	6 and 12 months
Secondary	Change in daily physical activity	International Physical Activity Questionnaire (IPAQ)	6 and 12 months
Secondary	Change in average steps per day	7-day average of steps/day measured by pedometers	6 and 12 months
Secondary	Change in eating behavior	Fragebogen zum Essverhalten (FEV; German questionnaire on eating behavior)	6 and 12 months
Secondary	Change in quality of life	Short form health survey (SF-36)	6 and 12 months
Secondary	Change of medical care expenses	routine data of health insurance company	6 and 12 months
Secondary	Change in weight	measured in kilograms (kg)	6 and 12 months
Secondary	Change in waist circumference	measured in centimeters (cm)	6 and 12 months
Secondary	Change in LDL-cholesterol concentrations	measured in milligram/deciliter (mg/dL)	6 and 12 months
Secondary	Change in HDL-cholesterol concentrations	measured in milligram/deciliter (mg/dL)	6 and 12 months
Secondary	Change in triglyceride concentrations	measured in milligram/deciliter (mg/dL)	6 and 12 months
Secondary	Change in systolic blood pressure	measured in millimeters of mercury (mmHG)	6 and 12 months
Secondary	Change in diastolic blood pressure	measured in millimeters of mercury (mmHG)	6 and 12 months
Secondary	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