A Comparison Between the Effects of Conventional Diets vs Intermittent Fasting Diabetic and Pre-diabetic Patients
Condition: Diabetes Mellitus, Type 2; PreDiabetes
MeSH terms: Diabetes Mellitus, Type 2; Prediabetic State; Glucose Intolerance
Study type: Interventional

Summary: 
      This research aims to find an effective dietary intervention among the Pakistani population.
      According to WHO, diabetes is on the rise in developing countries; the current prevalence
      among the Pakistani population is 11.2% which is expected to increase in the coming years
      which is in line with the similar documented trend in neighboring south Asian countries.3,11
      Since, ethnic south Asians carry a greater risk for developing T2D at a younger age and along
      with the complications associated with diabetes due to its chronicity, this poses a
      significant threat and an increased disease burden on the health care system.11

      This will be the first trial conducted on determining the efficacy of caloric restriction in
      a subset of Pakistani population. There is limited inconsistent data on the efficacy of
      time-restricted feeding, however, this will help elucidate if it does lead to positive
      effects on the bio-health markers. One of the major hurdles in caloric restriction is patient
      compliance, therefore, one of the intervention group will be used to determine if TRF with
      caloric restriction helps improve the patient's compliance and produces significant results.
      If such an intervention is effective in inducing weight loss it can also be applied for other
      overweight patients. Eventually, it will help in countering the rising obesity in the region.

      The ultimate purpose of the knowledge obtained is to find a patient friendly, novel and
      therapeutic dietary intervention which will help in limiting the rise in T2D patients. It'll
      help in introducing an effective lifestyle intervention to promote health, which will reduce
      the dependence on pharmacological therapies, as well as, in the long-term reduce burden on
      the health care system.

      The information obtained can provide framework for new guidelines in helping the patients to
      lose weight, which can be utilized by the government to increase general awareness which will
      help prevent diseases linked to obesity. In light of the randomized controlled trial, the
      primary health physicians can educate and increase awareness regarding the different dietary
      interventions the patients can utilize which will help increase the number of options for the
      patients. Social media platforms can be utilized due to their extended outreach for the
      transmission of accurate information to the general population.
    


Intervention name(s): Calorie Restriction; Time Restricted Feeding; Time Restricted Feeding with Calorie Restriction
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Participants assigned to this arm to consume food at a caloric deficit of 500 calories per day.; Participants assigned to this arm to consume food at maintenance calories (calories required per day to maintain weight, calculated based on height, weight and physical activity using the MyFitnessPal application) within an 8-hour window during daylight hours.; Participants assigned to this arm to consume food at a caloric deficit of 500 calories per day within an 8-hour window during daylight hours.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment