Intermittent fasting in Type 2 diabetes mellitus and the risk of hypoglycaemia: a randomized controlled trial

Abstract Aims To establish whether the risk of hypoglycaemia is greater with 2 consecutive days of very‐low‐calorie diet compared with 2 non‐consecutive days of very‐low‐calorie diet in people with Type 2 diabetes. Methods This was a non‐blinded randomized parallel group interventional trial of intermittent fasting in adults. The participants had a BMI of 30–45 kg/m 2 , Type 2 diabetes treated with metformin and/or hypoglycaemic medications and an HbA 1c concentration of 50–86 mmol/mol (6.7–10%). The participants followed a 2092–2510‐ kJ diet on 2 days per week for 12 weeks. A total of 41 participants were randomized 1:1 to consecutive ( n =19) or non‐consecutive ( n =22) day fasts, of whom 37 ( n =18 and n =19, respectively) were included in the final analysis. The primary outcome was difference in the rate of hypoglycaemia between the two study arms. Secondary outcomes included change in diet, quality of life, weight, lipid, glucose and HbA 1c levels, and liver function. Results The mean hypoglycaemia rate was 1.4 events over 12 weeks. Fasting increased the rate of hypoglycaemia despite medication reduction (RR 2.05, 95% CI 1.17 to 3.52). There was no difference between fasting on consecutive days and fasting on non‐consecutive days (RR 1.54, 95% CI 0.35 to 6.11). Improvements in weight, HbA 1c , fasting glucose and quality of life were experienced by participants in both arms. Conclusions In individuals with Type 2 diabetes on hypoglycaemic medications, fasting of any type increased the rate of hypoglycaemia. With education and medication reduction, fewer than expected hypoglycaemic events occurred. Although it was not possible to determine whether fasting on consecutive days increased the risk of hypoglycaemia, an acceptable rate was observed in both arms.