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Intermittent fasting could provide an alternative to classic caloric restriction in people with type 2 diabetes mellitus. The aim of the study is to determine the impact of a 12\u2010week intermittent fasting regimen compared with usual care in people with type 2 diabetes mellitus receiving insulin therapy.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>This open, single\u2010centre, randomized controlled trial investigates participants with type 2 diabetes mellitus on insulin therapy and a glycated haemoglobin A1c (HbA1c) of \u226553\u00a0mmol\/mol (\u22657.0%) and a minimum insulin dose of 0.3\u00a0IU\/kg body weight per day. Participants are randomized in a 1:1 ratio to either 12\u00a0weeks of intermittent fasting or the standard care group. All participants receive dietary counselling, continuous glucose monitoring, measurement of the resting metabolic rate, an oral glucose tolerance test, body composition measurement via dual\u2010energy X\u2010ray absorptiometry and stool samples for microbiome analyses at the beginning and at the end of the intervention. Two co\u2010primary outcomes (analysed in hierarchical order) were chosen for the study: (i) the difference in the change of HbA1c from baseline to 12\u00a0weeks and (ii) the difference in the number of participants achieving a combined end point encompassing a body weight reduction of at least 2%, an insulin dose reduction of at least 10% and an absolute HbA1c reduction of at least 3\u00a0mmol\/mol (0.3%) between the two groups.<\/jats:p><\/jats:sec>","DOI":"10.1111\/dme.14813","type":"journal-article","created":{"date-parts":[[2022,2,18]],"date-time":"2022-02-18T16:15:28Z","timestamp":1645200928000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":13,"title":["INTERmittent FASTing in people with insulin\u2010treated type 2 diabetes mellitus \u2013 the INTERFAST\u20102 study 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