@article{9163b37696244cd2afca95017effc9f6,
title = "Efficacy and Safety of Intermittent Fasting in People With Insulin-Treated Type 2 Diabetes (INTERFAST-2)—A Randomized Controlled Trial",
abstract = "OBJECTIVE To investigate the safety and feasibility of 3 nonconsecutive days of intermittent fasting (IF) per week over 12 weeks in participants with insulin-treated type 2 diabetes. RESEARCH DESIGN AND METHODS Forty-six people were randomized to an IF or control group. Dietary counseling and continuous glucose monitoring was provided. Coprimary end points were the change in HbA1c from baseline to 12 weeks and a composite end point (weight reduction ‡2%, insulin dose reduction ‡10%, and HbA1c reduction ‡3 mmol/mol). RESULTS The IF group showed a significant HbA1c reduction (27.3 ± 12.0 mmol/mol) compared with the control group (0.1 ± 6.1 mmol/mol) over 12 weeks (P = 0.012). The coprimary end point was achieved by 8 people in the IF and none in the control group (P < 0.001). No severe hypoglycemia occurred. CONCLUSIONS IF is a safe and feasible dietary option to ameliorate glycemic control while reduc-ing total daily insulin dose and body weight in insulin-treated people with type 2 diabetes.",
author = "Anna Obermayer and Tripolt, {Norbert J.} and Pferschy, {Peter N.} and Harald Kojzar and Faisal Aziz and Alexander Muller and Markus Schauer and Abderrahim Oulhaj and Felix Aberer and Caren Sourij and Hansjorg Habisch and Tobias Madl and Thomas Pieber and Barbara Obermayer-Pietsch and Vanessa Stadlbauer and Harald Sourij",
note = "Funding Information: Acknowledgments. The authors are very grateful to the study participants for their cooperation, Angela Jacan (Center for Biomarker Research in Medicine, CBmed, Graz, Austria) for her contribution to the development of the earliest version of the study protocol, Dr. Regina Riedl (Institute for Medical Informatics, Statistics and Documentation, Medical University of Graz, Graz, Austria) for her help with the sample size calculation, and the team of the Endocrinology Lab Platform (Medical University of Graz, Graz, Austria), especially Cornelia Missbrenner and Dorrit Mu€nzer-Ornik. Funding. The study was funded by the Austrian Science Fund (FWF) Programme Clinical Research grants KLI 851-B and KLI-1076 to H.S. and by grants P28854, I3792, DK-MCD W1226, and DOC-130 to T.M. T.M. was supported by Austrian Research Promotion Agency (FFG) grants 864690 and 870454, the Integrative Metabolism Research Center Graz, Austrian Infrastructure Program 2016/2017, the Styrian Government (Zukunfts-fonds, doc.funds program), the City of Graz, and BioTechMed-Graz (Flagship project DYNIMO). Duality of Interest. No potential conflicts of interest relevant to this article were reported. Author Contributions. A.Ob. wrote the final manuscript. A.Ob. and N.J.T. contributed to efficient project management and day-to-day operation. A.Ob., N.J.T., P.N.P., H.K., F.Az., A.M., F.Ab., C.S., T.P., B.O.-P., and V.S. contributed to collection, analysis, and interpretation of data. A.Ob., F.Az., and A.Ou. contributed to the statistical analysis. N.J.T. and H.S. significantly contributed to development of the study protocol. N.J.T. and H.S. contributed to acquiring ethical approval for the trial. F.Az., A.M., and H.S. had access to and verified the raw data. M.S. is the dietitian of the trial. H.H. and T.M. performed the me-tabolomics analysis. H.S. conceived the trial. All authors reviewed and contributed to the final manuscript. A.Ob. and H.S are the guarantors of this work and, as such, had full access to all data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Prior Presentation. Parts of this study were presented in abstract form at the 58th European Association for the Study of Diabetes (EASD) Annual Meeting, Stockholm, Sweden, 19–23 September 2022. Publisher Copyright: {\textcopyright} 2023 by the American Diabetes Association.",
year = "2023",
month = feb,
doi = "10.2337/dc22-1622",
language = "English",
volume = "46",
pages = "463--468",
journal = "Diabetes Care",
issn = "1935-5548",
publisher = "American Diabetes Association Inc.",
number = "2",
}