NCT03835923: LeIKD

Lifestyle Intervention in Chronic Ischemic Heart Disease and Diabetes

Completed NA Last updated 5 November 2021

What this trial tests

NA trial testing lifestyle intervention in Ischemic Heart Disease Chronic in 502 participants. Completed in 16 April 2021.

Timeline

12 February 2019

Primary endpoint
16 December 2020

16 April 2021

Quick facts

Lead sponsor	Techniker Krankenkasse
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	502
Start date	12 February 2019
Primary completion	16 December 2020
Estimated completion	16 April 2021
Sites	10 locations across Germany

Drugs / interventions tested

• lifestyle intervention
• usual care

Conditions studied

• Ischemic Heart Disease Chronic — all drugs for Ischemic Heart Disease Chronic →
• Diabetes Mellitus, Type 2 — all drugs for Diabetes Mellitus, Type 2 →

Sponsor

Techniker Krankenkasse

Who can join

18 and older, any sex, with Ischemic Heart Disease Chronic or Diabetes Mellitus, Type 2. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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 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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Telemedicine-supported lifestyle intervention for glycemic control in patients with CHD and T2DM: multicenter, randomized controlled trial.
   Mueller S, Dinges SMT, Gass F, Fegers-Wustrow I, et al · · 2025 · cited 12× · PMID 39920395 · DOI 10.1038/s41591-025-03498-w
2. Lifestyle Intervention in Chronic Ischaemic Heart Disease and Type 2 Diabetes (the LeIKD study): study protocol of a prospective, multicentre, randomised, controlled trial.
   von Korn P, Sydow H, Neubauer S, Duvinage A, et al · · 2021 · cited 7× · PMID 33558354 · DOI 10.1136/bmjopen-2020-042818
3. 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.
   Dinges SM, Krotz J, Gass F, Treitschke J, et al · · 2022 · cited 6× · PMID 35953083 · DOI 10.1177/14791641221113781
4. Use of Digital Health Technology in Heart Failure and Diabetes: a Scoping Review.
   Kallas D, Sandhu N, Gandilo C, Schleicher M, et al · · 2023 · cited 5× · PMID 35639339 · DOI 10.1007/s12265-022-10273-6