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

Sophia Mt Dinges, Janosch Krotz, Felix Gass, Julian Treitschke, Isabel Fegers-Wustrow, Marisa Geisberger, Katrin Esefeld, Pia von Korn, André Duvinage, Frank Edelmann, Oliver Wolfram, Julia Brandts, Ephraim B Winzer, Bernd Wolfarth, Felix Freigang, Sarah Neubauer, Thomas Nebling, Björn Hackenberg, Volker Amelung, Stephan Mueller, Martin Halle, Sophia Mt Dinges, Janosch Krotz, Felix Gass, Julian Treitschke, Isabel Fegers-Wustrow, Marisa Geisberger, Katrin Esefeld, Pia von Korn, André Duvinage, Frank Edelmann, Oliver Wolfram, Julia Brandts, Ephraim B Winzer, Bernd Wolfarth, Felix Freigang, Sarah Neubauer, Thomas Nebling, Björn Hackenberg, Volker Amelung, Stephan Mueller, Martin Halle

Abstract

Background: Lifestyle interventions are a cornerstone in the treatment of chronic ischaemic heart disease (CIHD) and type 2 diabetes mellitus (T2DM). This study aimed at identifying differences in clinical characteristics between categories of the common lifestyle intervention targets BMI, exercise capacity (peak V̇O2) and health literacy (HL).

Methods: Cross-sectional baseline characteristics of patients enrolled in the LeIKD trial (Clinicaltrials.gov NCT03835923) are presented in total, grouped by BMI, %-predicted peak V̇O2 and HL (HLS-EU-Q16), and compared to other clinical trials with similar populations.

Results: Among 499 patients (68.3±7.7 years; 16.2% female; HbA1c, 6.9±0.9%), baseline characteristics were similar to other trials and revealed insufficient treatment of several risk factors (LDL-C 92±34 mg/dl; BMI, 30.1±4.8 kg/m2; 69.6% with peak V̇O2<90% predicted). Patients with lower peak V̇O2 showed significantly higher (p < 0.05) CIHD and T2DM disease severity (HbA1c, CIHD symptoms, coronary artery bypass graft). Obese patients had a significantly higher prevalence of hypertension and higher triglyceride levels, whereas in patients with low HL both quality of life components (physical, mental) were significantly reduced.

Conclusions: In patients with CIHD and T2DM, peak V̇O2, BMI and HL are important indicators of disease severity, risk factor burden and quality of life, which reinforces the relevance of lifestyle interventions.

Keywords: Lifestyle; cardiorespiratory fitness; chronic coronary syndrome; disease management; exercise capacity; secondary prevention.

Conflict of interest statement

Declaration of conflicting interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: FE reported receiving grants from DFG, BMBF, Servier, and personal fees from Bayer Healthcare, Merck, Novartis, Servier, Berlin Chemie, Boehringer Ingelheim, Vifor Pharma, AstraZeneca and PharmaCosmos outside the submitted work. JB reported grants from AstraZeneca and personal fees from Amgen outside the submitted work. EBW reported receiving personal fees from Novartis (honoraria for lectures and advisory board activities), Boehringer Ingelheim (honoraria for advisory board activities) and CVRX (honoraria for lectures) outside the submitted work. BH reported receiving personal fees from IDS Diagnostic Systems outside the submitted work. MH reported receiving institutional funding from Techniker Krankenkasse (Health Insurance Company, Hamburg, Germany), grants from Novartis (principal investigator of the Activity Study in HFrEF) and personal fees from Bristol-Myers Squibb, Berlin Chemie-Menarini, Novartis, Daiichi-Sankyo, AstraZeneca, Roche, Abbott (advisory board on exercise and diabetes), Sanofi, Pfizer, Boehringer Ingelheim and Bayer, and serves as an advisor for Medical Park SE, Germany, outside the submitted work. All other authors (SMTD, JK, FG, JT, IFW, MG, KE, PvK, AD, OW, BW, FF, SN, TN, VA, SM) reported no conflict of interest with respect to the research, authorship, and/or publication of this article.

Figures

Figure 1.
Figure 1.
Patient recruitment in the LeIKD study. Abbreviations: CIHD, chronic ischaemic heart disease; T2DM, type 2 diabetes mellitus; aincluding re-screenings (initial screening failures may have been included during re-screening, n = 34).

References

    1. Global Health Estimates . 2020: deaths by cause, age, sex, by Country and by Region, 2000-2019. Geneva: World Health Organization, 2020.
    1. Cosentino F, Grant PJ, Aboyans V, et al. 2019 ESC Guidelines on diabetes, pre-diabetes, and cardiovascular diseases developed in collaboration with the EASD. Eur Heart J 2020; 41: 255–323. DOI: 10.1093/eurheartj/ehz486.
    1. Ferrannini G, Norhammar A, Gyberg V, et al. Is coronary artery disease inevitable in type 2 diabetes? From a glucocentric to a holistic view on patient management. Diabetes Care 2020; 43: 2001–2009. DOI: 10.2337/dci20-0002.
    1. Herrington W, Lacey B, Sherliker P, et al. Epidemiology of atherosclerosis and the potential to reduce the global burden of atherothrombotic disease. Circ Res 2016; 118: 535–546. DOI: 10.1161/circresaha.115.307611.
    1. Ferrannini G, de Bacquer D, De Backer G, et al. Screening for glucose perturbations and risk factor management in dysglycemic patients with coronary artery disease—A persistent challenge in need of substantial improvement: a report from ESC EORP EUROASPIRE V. Diabetes Care 2020: 43: 733. DOI: 10.2337/dc19-2165.
    1. Knuuti J, Wijns W, Saraste A, et al. 2019 ESC Guidelines for the diagnosis and management of chronic coronary syndromes: the task force for the diagnosis and management of chronic coronary syndromes of the European Society of Cardiology (ESC). Eur Heart J 2019; 41: 407–477. DOI: 10.1093/eurheartj/ehz425.
    1. Arnold SV, Bhatt DL, Barsness GW, et al. Clinical management of stable coronary artery disease in patients with type 2 diabetes mellitus: a scientific statement from the American heart association. Circulation 2020; 141: e779–e806. DOI: 10.1161/cir.0000000000000766.
    1. Diederichs C, Jordan S, Domanska O, et al. Health literacy in men and women with cardiovascular diseases and its association with the use of health care services - Results from the population-based GEDA2014/2015-EHIS survey in Germany. PLoS One 2018; 13: e0208303. DOI: 10.1371/journal.pone.0208303.
    1. von Korn P, Sydow H, Neubauer S, et al. 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; 11: e042818. DOI: 10.1136/bmjopen-2020-042818.
    1. Sevick MA, Korytkowski M, Stone RA, et al. Biophysiologic outcomes of the enhancing adherence in type 2 diabetes (ENHANCE) trial. J Acad Nutr Diet 2012; 112: 1147–1157. DOI: 10.1016/j.jand.2012.05.008.
    1. Gignac GE, Szodorai ET. Effect size guidelines for individual differences researchers. Pers Indiv Differ 2016; 102: 74–78. DOI: 10.1016/j.paid.2016.06.069.
    1. Gläser S, Ittermann T, Schäper C, et al. Referenzwerte für die Spiroergometrie – Ergebnisse der Study of Health in Pomerania (SHIP). Pneumologie 2013; 67: 58–63.
    1. Beaver WL, Wasserman K, Whipp BJ. A new method for detecting anaerobic threshold by gas exchange. J Appl Physiol 1986; 60: 2020–2027. DOI: 10.1152/jappl.1986.60.6.2020.
    1. Röthlin F, Pelikan J, Ganahl K. Die Gesundheitskompetenz der 15-jährigen Jugendlichen in Österreich. In Abschlussbericht der österreichischen Gesundheitskompetenz Jugendstudie im Auftrag des Hauptverbands der österreichischen Sozialversicherungsträger (HVSV), 2013.
    1. Ware JE, Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care 1992; 30: 473–483.
    1. Marx N, Rosenstock J, Kahn SE, et al. Design and baseline characteristics of the CARdiovascular outcome trial of LINAgliptin versus glimepiride in type 2 diabetes (CAROLINA®). Diab Vasc Dis Res 2015; 12: 164–174. DOI: 10.1177/1479164115570301.
    1. Rosenstock J, Kahn SE, Johansen OE, et al. Effect of linagliptin vs glimepiride on major adverse cardiovascular outcomes in patients with type 2 diabetes: The CAROLINA randomized clinical trial. JAMA 2019; 322: 1155–1166. DOI: 10.1001/jama.2019.13772.
    1. Rosenstock J, Perkovic V, Alexander JH, et al. Rationale, design, and baseline characteristics of the CArdiovascular safety and Renal Microvascular outcomE study with LINAgliptin (CARMELINA(®)): a randomized, double-blind, placebo-controlled clinical trial in patients with type 2 diabetes and high cardio-renal risk. Cardiovasc Diabetol 2018; 17: 39. DOI: 10.1186/s12933-018-0682-3.
    1. Byrkjeland R, Njerve IU, Anderssen S, et al. Effects of exercise training on HbA1c and VO2peak in patients with type 2 diabetes and coronary artery disease: a randomised clinical trial. Diab Vasc Dis Res 2015; 12: 325–333. DOI: 10.1177/1479164115590552.
    1. Bray G, Gregg E, Haffner S, et al. Baseline characteristics of the randomised cohort from the Look AHEAD (Action for Health in Diabetes) study. Diab Vasc Dis Res 2006; 3: 202–215. DOI: 10.3132/dvdr.2006.031.
    1. Piché ME, Tchernof A, Després JP. Obesity phenotypes, diabetes, and cardiovascular diseases. Circ Res 2020; 126: 1477–1500. DOI: 10.1161/circresaha.120.316101.
    1. Fang ZY, Sharman J, Prins JB, et al. Determinants of exercise capacity in patients with type 2 diabetes. Diab Care 2005; 28: 1643–1648. DOI: 10.2337/diacare.28.7.1643.
    1. Winzer EB, Woitek F, Linke A. Physical activity in the prevention and treatment of coronary artery disease. J Am Heart Assoc 2018; 7: e007725. DOI: 10.1161/jaha.117.007725.
    1. Nesti L, Pugliese NR, Sciuto P, et al. Type 2 diabetes and reduced exercise tolerance: a review of the literature through an integrated physiology approach. Cardiovasc Diabetol 2020; 19: 134. DOI: 10.1186/s12933-020-01109-1.
    1. Kumar N, Garg A, Bhatt DL, et al. Empagliflozin improves cardiorespiratory fitness in type 2 diabetes: translational implications. Can J Physiol Pharmacol 2018; 96: 1184–1187. DOI: 10.1139/cjpp-2018-0359.
    1. Magnani JW, Mujahid MS, Aronow HD, et al. Health literacy and cardiovascular disease: fundamental relevance to primary and secondary prevention: a scientific statement from the American Heart Association. Circulation 2018; 138: e48–e74. DOI: 10.1161/cir.0000000000000579.
    1. Bruthans J, Mayer O, Jr, De Bacquer D, et al. Educational level and risk profile and risk control in patients with coronary heart disease. Eur J Prev Cardiol 2016; 23: 881–890. DOI: 10.1177/2047487315601078.
    1. Schmitz R, Jordan S, Müters S, et al. Population-wide use of behavioural prevention and counselling programmes for lifestyle-related cardiovascular risk factors in Germany. Eur J Prev Cardiol 2012; 19: 849–856. DOI: 10.1177/1741826711410949.
    1. Jin X, Chandramouli C, Allocco B, et al. Women’s participation in cardiovascular clinical trials from 2010 to 2017. Circulation 2020; 141: 540–548. DOI: 10.1161/circulationaha.119.043594.
    1. Ferrannini G, De Bacquer D, Vynckier P, et al. Gender differences in screening for glucose perturbations, cardiovascular risk factor management and prognosis in patients with dysglycaemia and coronary artery disease: results from the ESC-EORP EUROASPIRE surveys. Cardiovasc Diabetol 2021; 20: 38. DOI: 10.1186/s12933-021-01233-6.
    1. Wasserman K, Hansen J, Sue DY, et al. Principles of exercise testing and interpretation: Including pathophysiology and clinical applications. 5th ed. Philadelphia: Lippincott Williams & Wilkins, 2011, p. 1–592.

Source: PubMed

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