Therapeutic Effects of Time Restricted Feeding and Calorie Restriction in Patients with Prediabetes and Diabetes in Pakistan: Study Protocol for a Randomized Control Trial (Preprint)

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BACKGROUND Type 2 diabetes is a chronic medical condition that is associated with high morbidity and mortality. The prevalence of type 2 diabetes has been increasing over the past few decades. While most interventions are aimed at managing the symptoms of type 2 diabetes, few of these interventions have proven to be effective in preventing the progression of the disease. Weight loss is one of the few known interventions that has been proven to delay the progression to diabetes from the prediabetic state and results in an improvement in symptoms with a reduced dependence on pharmacological therapy. The methods commonly used to achieve weight loss are calorie restriction (CR) and time-restricted feeding (TRF). The purpose of this study was to determine whether CR, TRF, or CR with TRF is the most ideal method for treating patients with prediabetes and diabetes and to determine the effects of these interventions on body weight, blood sugar levels and the serum lipid profile. OBJECTIVE The objectives of our study are to determine the effects of TRF alone, TRF with CR, and CR alone on disease markers and clinical parameters of diabetes such as body weight, blood sugar levels and serum lipid profile. METHODS This will be a randomized controlled clinical trial. The subjects who met the inclusion criteria will be randomly divided into four of the following groups: 1) CR 2) TRF 3) TRF with CR and 4) Control. Patients will be asked to document their food intake with the assistance of MyFitnessPal application and to track their fasting hours using the Zero application. Body weight, BMI, vital signs, fasting plasma glucose, HbA1c and lipid profiles will be assessed at baseline and at weeks 4 and 12. RESULTS This study received approval from the Ethics Review Committee of the Aga Khan University in 2020. Enrollment of the clinical trial completed in May 2021. Full and final results of the trial will be published in a separate manuscript and shared with the broader medical community in a separate manuscript by the end of 2024 and through conference proceedings. Initial results indicate a statistically significant reduction in the TRF and combined (TRF+CR) cohorts as well as a statistically significant reduction in the fasting blood sugar levels of study participants. CONCLUSIONS The ultimate purpose of this study is to identify a patient-friendly, novel and therapeutic dietary intervention that will help limit the risk of type 2 diabetes. This study will help in introducing an effective lifestyle intervention to promote health, which will reduce the dependence on pharmacological therapies as well as the burden on the healthcare system in the long term. CLINICALTRIAL Registry: ClinicalTrials.gov ClinicalTrials.gov ID: NCT04463277 URL of Trial Registry Record: https://classic.clinicaltrials.gov/ct2/show/NCT04463277