Clinical trial NCT03835923: Lifestyle Intervention in Chronic Ischemic Heart Disease and Diabetes
Official title: Lifestyle Intervention in Chronic Ischemic Heart Disease and Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ischemic Heart Disease Chronic
Diabetes Mellitus, Type 2
Keywords: lifestyle intervention
chronic ischemic heart disease
diabetes mellitus type 2
cardiovascular risk factors
health literacy
telemedicine
cross-sectoral care
HbA1c
individual exercise training
dietary change
sustainability
heart disease
nutrition
exercise
physical activity
coronary artery disease
coronary heart disease
Lead sponsor: Techniker Krankenkasse
Sponsor class: OTHER
Collaborators: name: Technical University of Munich
name: privates Institut für angewandte Versorgungsforschung GmbH
name: IDS Diagnostic Systems AG
name: Federal Joint Committee
First posted: 2019-02-11
Enrollment: 502
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in HbA1c
timeFrame: 6 months
Secondary outcomes:
measure: Change in HbA1c
timeFrame: 12 months
measure: Change in health literacy
timeFrame: 6 and 12 months
measure: Change in daily physical activity
timeFrame: 6 and 12 months
measure: Change in average steps per day
timeFrame: 6 and 12 months
measure: Change in eating behavior
timeFrame: 6 and 12 months
measure: Change in quality of life
timeFrame: 6 and 12 months
measure: Change of medical care expenses
timeFrame: 6 and 12 months
measure: Change in weight
timeFrame: 6 and 12 months
measure: Change in waist circumference
timeFrame: 6 and 12 months
measure: Change in LDL-cholesterol concentrations
timeFrame: 6 and 12 months
measure: Change in HDL-cholesterol concentrations
timeFrame: 6 and 12 months
measure: Change in triglyceride concentrations
timeFrame: 6 and 12 months
measure: Change in systolic blood pressure
timeFrame: 6 and 12 months
measure: Change in diastolic blood pressure
timeFrame: 6 and 12 months
measure: Number of the combined endpoint "4P-MACE"
timeFrame: 6 and 12 months
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: University Hospital: Rheinisch-Westfälische Technische Hochschule Aachen
city: Berlin
country: Germany
facility: University Hospital: Charité - Universitätsmedizin Berlin
city: Dresden
country: Germany
facility: University Hospital: Herzzentrum Dresden
city: Freiburg
country: Germany
facility: University Hospital: Universitäts-Herzzentrum Freiburg - Bad Krozingen
city: Greifswald
country: Germany
facility: University Hospital: Universitätsmedizin Greifswald
city: Kassel
country: Germany
facility: Doctor's Practice: Dr. Rüdell
city: Leipzig
country: Germany
facility: University Hospital: Klinik und Poliklinik für Kardiologie - Universitätsklinikum Leipzig
city: Magdeburg
country: Germany
facility: University Hospital: Magdeburg
city: Munich
country: Germany
facility: University Hospital: Klinikum rechts der Isar, Technische Universität München
city: Villingen-Schwenningen
country: Germany
facility: Doctor's Practice: Prof. Dr. Jacob und Dr. Jacob
Study officials:
affiliation: Klinikum rechts der Isar Technische Universität München
name: Martin Halle, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.