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Obermayer, A; Tripolt, NJ; Pferschy, PN; Kojzar, H; Jacan, A; Schauer, M; Aziz, F; Oulhaj, A; Aberer, F; Sourij, C; Obermayer-Pietsch, B; Stadlbauer, V; Sourij, H.
INTERmittent FASTing in people with insulin-treated type 2 diabetes mellitus - the INTERFAST-2 study protocol.
Diabet Med. 2022; 39(6):e14813
Doi: 10.1111/dme.14813
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- Leading authors Med Uni Graz
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Obermayer Anna Maria Antonia
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Sourij Harald
- Co-authors Med Uni Graz
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Aberer Felix
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Aziz Faisal
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Jacan Angela
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Kojzar Harald
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Obermayer-Pietsch Barbara
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Pferschy Peter
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Schauer Markus
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Sourij Caren
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Stadlbauer-Köllner Vanessa
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Tripolt Norbert
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- Abstract:
- AIM: Intermittent fasting, a dietary intervention of alternate eating and fasting, has gained popularity in people trying to lose weight. 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-week intermittent fasting regimen compared with usual care in people with type 2 diabetes mellitus receiving insulin therapy. METHODS: This open, single-centre, randomized controlled trial investigates participants with type 2 diabetes mellitus on insulin therapy and a glycated haemoglobin A1c (HbA1c) of ≥53 mmol/mol (≥7.0%) and a minimum insulin dose of 0.3 IU/kg body weight per day. Participants are randomized in a 1:1 ratio to either 12 weeks 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-energy X-ray absorptiometry and stool samples for microbiome analyses at the beginning and at the end of the intervention. Two co-primary outcomes (analysed in hierarchical order) were chosen for the study: (i) the difference in the change of HbA1c from baseline to 12 weeks 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 mmol/mol (0.3%) between the two groups.
- Find related publications in this database (using NLM MeSH Indexing)
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Blood Glucose - metabolism
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Blood Glucose Self-Monitoring - administration & dosage
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Diabetes Mellitus, Type 2 - drug therapy
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Fasting - administration & dosage
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Glycated Hemoglobin A - metabolism
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Humans - administration & dosage
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Hypoglycemic Agents - therapeutic use
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Insulin - metabolism, therapeutic use
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Randomized Controlled Trials as Topic - administration & dosage
- Find related publications in this database (Keywords)
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insulin sensitivity
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insulin therapy
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Intermittent fasting
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type 2 diabetes mellitus (T2DM)
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weight loss