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SHR Neuro Cancer Cardio Lipid Metab Microb

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 [OPEN ACCESS]
Web of Science PubMed PUBMED Central FullText FullText_MUG

 

Leading authors Med Uni Graz
Obermayer Anna Maria Antonia
Sourij Harald
Co-authors Med Uni Graz
Aberer Felix
Aziz Faisal
Jacan Angela
Kojzar Harald
Obermayer-Pietsch Barbara
Pferschy Peter
Schauer Markus
Sourij Caren
Stadlbauer-Köllner Vanessa
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)
Blood Glucose - metabolism
Blood Glucose Self-Monitoring - administration & dosage
Diabetes Mellitus, Type 2 - drug therapy
Fasting - administration & dosage
Glycated Hemoglobin A - metabolism
Humans - administration & dosage
Hypoglycemic Agents - therapeutic use
Insulin - metabolism, therapeutic use
Randomized Controlled Trials as Topic - administration & dosage

Find related publications in this database (Keywords)
insulin sensitivity
insulin therapy
Intermittent fasting
type 2 diabetes mellitus (T2DM)
weight loss
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