A Comparison Between the Effects of Conventional Diets vs Intermittent Fasting Diabetic and Pre-diabetic Patients

Study Overview
=================
Brief 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.

Official Title
-----------------
Therapeutic Effects of Time Restricted Feeding and Calorie Restriction in Patients With Prediabetes and Diabetes

Conditions
-----------------
Diabetes Mellitus, Type 2, PreDiabetes

Intervention / Treatment
-----------------
* Behavioral: Calorie Restriction
* Behavioral: Time Restricted Feeding
* Behavioral: Time Restricted Feeding with Calorie Restriction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Glycemic values belonging to diabetes or prediabetes category. Weight stable for at least 6 months prior to start of study. Ability to understand English and use English language mobile applications. Exclusion Criteria: Pregnant or breastfeeding women. Diabetics taking insulin or sulfonylureas. Smokers. History of cardiovascular disease. History of psychiatric or eating disorders. History of hypoglycemic episodes.

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Calorie Restriction<br> | Behavioral: Calorie Restriction<br>* Participants assigned to this arm to consume food at a caloric deficit of 500 calories per day.<br>|
| Experimental: Time Restricted Feeding<br> | Behavioral: Time Restricted Feeding<br>* 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.<br>|
| Experimental: Time Restricted Feeding with Calorie Restriction<br> | Behavioral: Time Restricted Feeding with Calorie Restriction<br>* 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.<br>|
| No Intervention: Control<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight | Change in participants' weight. | 12 weeks | 
| FBS | Change in participants' fasting plasma glucose levels. | 12 weeks | 
| HbA1c | Change in percentage of glycated hemoglobin HbA1c in the participants' plasma. | 12 weeks | 
| OGTT | Change in participants' response to an oral glucose load. | 12 weeks | 
| Serum Lipid Profile. | Change in participant's serum lipid levels, including cholesterol, LDL, HDL and triglycerides. | 12 weeks |