Ischemic Heart Disease ChronicLeIKDNCT03835923
Lifestyle Intervention in Chronic Ischemic Heart Disease and Diabetes
A study testing lifestyle intervention in people with Ischemic Heart Disease Chronic and Diabetes Mellitus, Type 2, run by Techniker Krankenkasse at 10 sites in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Heart Disease Chronic, Diabetes Mellitus, Type 2
- What is being tested?
- lifestyle intervention
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 502 participants
- Where
- 10 sitesGermany
- Study dates
- 12 Feb 2019to 16 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 16Show fewer
- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Germany10 sites
University Hospital: Rheinisch-Westfälische Technische Hochschule Aachen
Aachen
University Hospital: Charité - Universitätsmedizin Berlin
Berlin
University Hospital: Herzzentrum Dresden
Dresden
University Hospital: Universitäts-Herzzentrum Freiburg - Bad Krozingen
Freiburg im Breisgau
University Hospital: Universitätsmedizin Greifswald
Greifswald
Doctor's Practice: Dr. Rüdell
Kassel
University Hospital: Klinik und Poliklinik für Kardiologie - Universitätsklinikum Leipzig
Leipzig, 04103
University Hospital: Magdeburg
Magdeburg
University Hospital: Klinikum rechts der Isar, Technische Universität München
Munich
Doctor's Practice: Prof. Dr. Jacob und Dr. Jacob
Villingen-Schwenningen
About this study
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.
Read the 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.
- Being tested
- lifestyle intervention, usual care
- 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
- Medical subject headings
- Diabetes Mellitus, Type 2, Heart Diseases, Motor Activity, Coronary Artery Disease, Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lifestyle interventionBehavioural
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 careBehavioural
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)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: lifestyle intervention |
| usual care | Active comparator | general exercise and nutritional recommendations according to current guidelines Receives: Behavioral: usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c
measured in percent (%)
Measured: 6 months
Secondary outcomes (15)
Change in HbA1c
measured in percent (%)
Measured: 12 months
Change in health literacy
European Health Literacy Survey Questionnaire (HLS-EU-Q16)
Measured: 6 and 12 months
Change in daily physical activity
International Physical Activity Questionnaire (IPAQ)
Measured: 6 and 12 months
Change in average steps per day
7-day average of steps/day measured by pedometers
Measured: 6 and 12 months
Change in eating behavior
Fragebogen zum Essverhalten (FEV; German questionnaire on eating behavior)
Measured: 6 and 12 months
Change in quality of life
Short form health survey (SF-36)
Measured: 6 and 12 months
Change of medical care expenses
routine data of health insurance company
Measured: 6 and 12 months
Change in weight
measured in kilograms (kg)
Measured: 6 and 12 months
Change in waist circumference
measured in centimeters (cm)
Measured: 6 and 12 months
Change in LDL-cholesterol concentrations
measured in milligram/deciliter (mg/dL)
Measured: 6 and 12 months
Change in HDL-cholesterol concentrations
measured in milligram/deciliter (mg/dL)
Measured: 6 and 12 months
Change in triglyceride concentrations
measured in milligram/deciliter (mg/dL)
Measured: 6 and 12 months
Change in systolic blood pressure
measured in millimeters of mercury (mmHG)
Measured: 6 and 12 months
Change in diastolic blood pressure
measured in millimeters of mercury (mmHG)
Measured: 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
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2019
- Study start12 Feb 2019
- Primary completion16 Dec 2020
- Study completion16 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Ischemic Heart Disease ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 502 participants (actual)
Sponsor and investigators
- Lead sponsor
- Techniker Krankenkasse
- Sponsor type
- University, hospital or other
- Collaborators
- Technical University of Munich, privates Institut für angewandte Versorgungsforschung GmbH, IDS Diagnostic Systems AG, Federal Joint Committee
- Responsible party
- Principal investigator, Prof. Dr. med. Martin Halle, Technical University of Munich
- Investigators
- Martin Halle, Prof. Dr. med., Principal investigator, Technical University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03835923
- Sponsor's protocol ID
- 01NVF17015
- Other IDs
- DRKS00015140
- Acronym
- LeIKD
- Status last verified
- Nov 2021
- First submitted
- 1 Feb 2019
- Last updated
- 5 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39920395Dinges 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.
PubMed 35953083von 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.
PubMed 33558354
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lifestyle Intervention in Chronic Ischemic Heart Disease and Diabetes
- ClinicalTrials.gov ID
- NCT03835923
- Acronym / sponsor ID
- LeIKD / 01NVF17015
- Keywords
- lifestyle intervention, chronic ischemic heart disease, diabetes mellitus type 2, cardiovascular risk factors, health literacy, telemedicine, cross-sectoral care, HbA1c
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 502 participants (actual)
- Lead sponsor
- Techniker KrankenkasseUniversity, hospital or other
- Collaborators
- Technical University of Munich, privates Institut für angewandte Versorgungsforschung GmbH, IDS Diagnostic Systems AG, Federal Joint Committee
- Study start
- 12 Feb 2019 (actual)
- Primary completion
- 16 Dec 2020 (actual)
- Study completion
- 16 Apr 2021 (actual)
- First posted
- 11 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lifestyle intervention | Experimental | Behavioral: lifestyle interventionTelemedicine-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 | Behavioral: usual caregeneral exercise and nutritional recommendations according to current guidelines |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (16 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lifestyle interventionintervention 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. | Behavioural | lifestyle intervention |
| usual careRecommendation 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) | Behavioural | usual care |
Primary outcome
Change in HbA1c
Time frame: 6 months
measured in percent (%)
15 secondary outcomes
Change in HbA1c
Time frame: 12 months
Change in health literacy
Time frame: 6 and 12 months
Change in daily physical activity
Time frame: 6 and 12 months
Change in average steps per day
Time frame: 6 and 12 months
Change in eating behavior
Time frame: 6 and 12 months
Change in quality of life
Time frame: 6 and 12 months
Change of medical care expenses
Time frame: 6 and 12 months
Change in weight
Time frame: 6 and 12 months
Change in waist circumference
Time frame: 6 and 12 months
Change in LDL-cholesterol concentrations
Time frame: 6 and 12 months
Change in HDL-cholesterol concentrations
Time frame: 6 and 12 months
Change in triglyceride concentrations
Time frame: 6 and 12 months
Change in systolic blood pressure
Time frame: 6 and 12 months
Change in diastolic blood pressure
Time frame: 6 and 12 months
Number of the combined endpoint "4P-MACE"
Time frame: 6 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2021.
- Derived from this study: PubMed 39920395Mueller 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.
- Derived from this study: PubMed 35953083Dinges 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.
- Derived from this study: PubMed 33558354von 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Halle, Prof. Dr. med. principal investigator
Technical University of Munich
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lifestyle intervention in people with Ischemic Heart Disease Chronic and Diabetes Mellitus, Type 2, run by Techniker Krankenkasse at 10 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HbA1c (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03835923, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2021.