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INTERmittent FASTing in people with insulin-treated type 2 diabetes mellitus - the INTERFAST-2 study protocol.

Authors :
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
Source :
Diabetic medicine : a journal of the British Diabetic Association [Diabet Med] 2022 Jun; Vol. 39 (6), pp. e14813. Date of Electronic Publication: 2022 Feb 28.
Publication Year :
2022

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.<br />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.<br /> (© 2022 The Authors. Diabetic Medicine published by John Wiley & Sons Ltd on behalf of Diabetes UK.)

Details

Language :
English
ISSN :
1464-5491
Volume :
39
Issue :
6
Database :
MEDLINE
Journal :
Diabetic medicine : a journal of the British Diabetic Association
Publication Type :
Academic Journal
Accession number :
35179802
Full Text :
https://doi.org/10.1111/dme.14813