{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,22]],"date-time":"2026-07-22T23:42:42Z","timestamp":1784763762712,"version":"3.55.0"},"reference-count":45,"publisher":"BMJ","issue":"10","license":[{"start":{"date-parts":[[2023,10,15]],"date-time":"2023-10-15T00:00:00Z","timestamp":1697328000000},"content-version":"unspecified","delay-in-days":14,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"The Mirella and Lino Saputo Research Chair in Cardiovascular Health and the Prevention of Cognitive Decline from Universit\u00e9 de Montr\u00e9al at the Montreal Heart Institute.","award":["N\/A"],"award-info":[{"award-number":["N\/A"]}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"published-print":{"date-parts":[[2023,10]]},"abstract":"<jats:sec><jats:title>Introduction<\/jats:title><jats:p>Despite proven programmes, implementing lifestyle interventions for pre-diabetes and type 2 diabetes is challenging. Cardiac rehabilitation, provide a valuable opportunity to promote the adoption of healthy lifestyle behaviours for patients with atherosclerotic cardiovascular disease (ASCVD). However, only a limited number of studies have explored the potential for reversing the underlying causes of ASCVD in this setting.<\/jats:p><\/jats:sec><jats:sec><jats:title>Objectives<\/jats:title><jats:p>The DIABEPIC1 study is an ongoing single-arm lifestyle clinical trial to assess the feasibility of an upgraded 6-month intensive cardiac rehabilitation programme combining an innovative diet assignment with exercise training to reverse newly onset pre-diabetes (glycated haemoglobin 5.7%\u20136.4%) to normal glucose concentrations in patients with coronary heart disease.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods and analysis<\/jats:title><jats:p>36 patients referred from the Montreal Heart Institute for cardiac rehabilitation, aged \u226540 years with a recent diagnosis of pre-diabetes in the last 6\u2009months, will be offered to participate in the upgraded programme. Interventions will include four sessions of nutritional counselling on ultra-processed foods intake reduction and a moderate-carbohydrate (&lt;40%) ad libitum Mediterranean diet coupled with 36 1-hour sessions of supervised exercise training (continuous and interval aerobic training, and resistance training) and educational intervention. Phase 2 will continue the same interventions adding 8:16 hour time-restricting eating (TRE) at least 5\u2009days per week. During this second phase, exercise training will be performed with autonomy.<jats:italic>The primary objectives<\/jats:italic>will be to evaluate the recruitment rate, the completion rates at 3 and 6 months, and the compliance of participants.<jats:italic>The secondary objectives<\/jats:italic>will be to assess the proportion of prediabetic participants in remission of pre-diabetes at the programme\u2019s end and to characterise the factors associated with remission.<\/jats:p><\/jats:sec><jats:sec><jats:title>Ethics and dissemination<\/jats:title><jats:p>The DIABEPIC1 feasibility study is approved by the Research Ethics Board of the Montreal Heart Institute (Project Number ICM 2022-3005). Written informed consent will be obtained from each participant prior to inclusion. Results will be available through research articles and conferences.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>The DIABEPIC1 trial will examine the feasibility and effectiveness of an enhanced cardiac rehabilitation programme combining exercise training with an ultra-processed food reduction intervention, a Mediterranean diet, and TRE counselling to remit pre-diabetes to normal glucose concentrations.<\/jats:p><\/jats:sec><jats:sec><jats:title>Trial registration number<\/jats:title><jats:p><jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" specific-use=\"clinicaltrial \" xlink:href=\"NCT05459987\">NCT05459987<\/jats:ext-link>.<\/jats:p><\/jats:sec>","DOI":"10.1136\/bmjopen-2023-073763","type":"journal-article","created":{"date-parts":[[2024,2,15]],"date-time":"2024-02-15T03:37:17Z","timestamp":1707968237000},"page":"e073763","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":10,"title":["Mediterranean diet and time-restricted eating as a cardiac rehabilitation approach for patients with coronary heart disease and pre-diabetes: the DIABEPIC-1 protocol of a feasibility trial"],"prefix":"10.1136","volume":"13","clinical-trial-number":[{"clinical-trial-number":"isrctn05459987","registry":"10.18810\/isrctn"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3269-6455","authenticated-orcid":false,"given":"Josep","family":"Iglesies-Grau","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Val\u00e9rie","family":"Dionne","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"\u00c9lise","family":"Latour","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mathieu","family":"Gayda","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Florent","family":"Besnier","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel","family":"Gagnon","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Am\u00e9lie","family":"Debray","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christine","family":"Gagnon","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"V\u00e9ronique","family":"Pelletier","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anil","family":"Nigam","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Philippe L","family":"L\u2019Allier","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Martin","family":"Juneau","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nadia","family":"Bouabdallaoui","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Louis","family":"Bherer","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2023,10,17]]},"reference":[{"key":"2024020708332730000_13.10.e073763.1","doi-asserted-by":"publisher","DOI":"10.1016\/j.diabres.2019.107843"},{"key":"2024020708332730000_13.10.e073763.2","doi-asserted-by":"publisher","DOI":"10.2337\/dc17-1962"},{"key":"2024020708332730000_13.10.e073763.3","doi-asserted-by":"crossref","first-page":"753","DOI":"10.1016\/j.jcjd.2022.10.004","article-title":"Remission of type 2 diabetes","volume":"46","author":"MacKay","year":"2022","journal-title":"Canadian Journal of Diabetes"},{"key":"2024020708332730000_13.10.e073763.4","doi-asserted-by":"publisher","DOI":"10.2337\/dc22-S002"},{"key":"2024020708332730000_13.10.e073763.5","doi-asserted-by":"crossref","first-page":"1627","DOI":"10.1007\/s40520-022-02092-1","article-title":"Videoconference version of the Montreal cognitive assessment: normative data for Quebec-French people aged 50 years and older","volume":"34","author":"Gagnon","year":"2022","journal-title":"Aging Clin Exp Res"},{"key":"2024020708332730000_13.10.e073763.6","doi-asserted-by":"publisher","DOI":"10.1093\/eurheartj\/ehz350"},{"key":"2024020708332730000_13.10.e073763.7","doi-asserted-by":"publisher","DOI":"10.1161\/HYP.0000000000000033"},{"key":"2024020708332730000_13.10.e073763.8","doi-asserted-by":"publisher","DOI":"10.1590\/S0102-311X2010001100005"},{"key":"2024020708332730000_13.10.e073763.9","unstructured":"ACSM Books . 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