INTERmittent FASTing in people with insulin‐treated type 2 diabetes mellitus – the INTERFAST‐2 study protocol

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.

Efficacy of Fasting in Type 1 and Type 2 Diabetes Mellitus: A Narrative Review

“…Besides hypoglycemia, the main adverse effects are psychological and physiological disorders such as anxiety and muscle wasting. Furthermore, IF may have an additional impact on insulin dosing in people with T2DM [ 96 ]. Multidisciplinary treatment can mitigate the most adverse effects, including the psychological and physiological distress of the diet.…”

Intermittent Fasting—A Healthy Dietary Pattern for Diabetic Nephropathy

“…In addition, serious risk factors must be considered in managing the complex association of insulin and fasting, as patients receiving high insulin doses are at greater risk for hypoglycemia during IF. Therefore, accurately regulating the amount of insulin used during fasting is critical for the prevention of hypoglycemia [ 98 ]. Despite IF being well studied in various metabolic diseases, its association with DN still needs to be extensively investigated.…”

Efficacy and Safety of Intermittent Fasting in People With Insulin-Treated Type 2 Diabetes (INTERFAST-2)—A Randomized Controlled Trial

“…To reduce the risk of hypoglycemia during the IF days, participants were given an insulin dose adjustment protocol for fasting days (Supplementary Table 2). Oral nonsulfonylurea medication was continued on fasting days (9). All participants used a FreeStyle Libre continuous glucose monitoring system (CGM; Abbott Diabetes Care, Alameda, CA) device for the 12 weeks of the study and the insulin switch phase.…”

“…This open, single-center, randomized, controlled trial, Intermittent fasting in subjects with insulin-treated type 2 diabetes mellitus (INTERFAST-2), was conducted at the University Hospital Graz, Graz, Austria, and approved by the ethics committee of the Medical University of Graz, Graz, Austria (EK 30-350 ex 17/18). The detailed study protocol was published previously ( 9 ). Briefly, this study included volunteers, aged between 18 and 75 years (both inclusive), with insulin-treated type 2 diabetes, an HbA 1c ≥53 mmol/mol (≥7.0%), and a daily insulin dose of ≥0.3 IU/kg body wt.…”

“…To reduce the risk of hypoglycemia during the IF days, participants were given an insulin dose adjustment protocol for fasting days ( Supplementary Table 2 ). Oral nonsulfonylurea medication was continued on fasting days ( 9 ).…”