A Prospective Study on the Impact of Intermittent Fasting on Insulin Sensitivity and Metabolic Markers in Overweight and Obese Adults with Type 2 Diabetes- Study protocol

Abstract

Background: The obesity and Type 2 Diabetes Mellitus (T2DM) epidemic in the world is a critical community health issue, which majorly is a result of insulin resistance. Intermittent fasting (IF) is a new dietary therapy with a prospective to become a viable solution through its alternating phases of starvation and food intake in the effort to enhance metabolic health. Although short term studies are positive, there is a lack of long-term data on its effectiveness in enhancing insulin sensitivity and other important metabolic indicators in overweight and obese diabetic patients.

Aim: To evaluate the treatment of insulin sensitivity and a full range of metabolism indicators in overweight and obese adults with T2DM on the effect of a 24-month intermittent fasting program.

Methods: The prospective observational study will involve 210 participants who have T2DM (BMI 25 kg/m2). The participants will be subjected to a time-limited diet (16:8) (8-hour to eat, 16 hours to starve). At baseline and after the 24-month study period, anthropometric measurements (weight, BMI, waist/ hip circumference), biochemical measures (fasting plasma glucose, HbA1c, lipid profile, leptin, beta-hydroxybutyrate, high-sensitivity C-Reactive Protein), and dietary adherence will be measured. Paired t-tests and correlation analysis based on the SPSS version 25.0 will be used to perform statistical analysis.

Conclusion: The current study will attempt to give strong, sustainable evidence on the sustainability and metabolic advantage of intermittent fasting. It is hoped that the findings will be used to inform evidence-based lifestyle interventions in the management of T2DM and the minimization of the effects of obesity complications..