Metabolic and Hormonal Effects of 5:2 Intermittent Fasting in Patients With Type 2 Diabetes and Subjects With Adiposity

Background: It is well known that the majority of the population in the western world eats too much calories in relation to physical activity. This results in increased body weight, insulin resistance and premature age-related diseases such as diabetes, hypertension, cardiovascular disease, even dementia and certain types of cancer like colon cancer and breast cancer.

Several studies have shown that calorie restriction (CR) reduces the risk for cardiovascular disease, diabetes and Alzheimer's disease. Animal studies have shown that CR reduces insulin like growth factor-1 (IGF-1) levels, cancer incidence and prolong lifespan. Chronic every day CR decreases blood lipids and glucose, blood pressure, insulin resistance and inflammatory markers. It has been shown to reduce incidence of atherosclerosis directly correlated to the CR and not to weight reduction. However, only few studies have investigated the effect of periodic CR in healthy subjects with adiposity and in patients with type 2 diabetes. Moreover, no studies to our knowledge have studied if there is any gender differences in the metabolic response to periodic CR or if the response is dependent on the degree of adiposity and metabolic disturbance. Since it for many people is very difficult to every day reduce caloric intake , the new method to reduce it to 25% of the normal intake during two days a week is of a great interest to study regarding the metabolic and hormonal effects in men and women.

Questions to be answered; Do women and men respond differently to this diet and do subjects with type 2 diabetes respond differently to those without diabetes. How many subjects can continue to follow this new diet during the 6 months study and during further 6 months follow up?

Primary end points: Change from baseline in fasting serum insulin, C-peptide and insulin like factor binding protein-1 (IGFBP-1) in 6 months.

Secondary end points: Changes in body composition including body fat percentage, blood pressure, blood lipids, blood glucose, markers of inflammation, oxidative stress and hormones regulating appetite, and changes in wellbeing, diet habits and physical activity.