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

NCT04463277 | Completed DMC

• 1 other identifier: IFCR-186
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2; PreDiabetes

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (4)

Calorie Restriction

EXPERIMENTAL

Behavioral: Calorie Restriction

Time Restricted Feeding

EXPERIMENTAL

Behavioral: Time Restricted Feeding

Time Restricted Feeding with Calorie Restriction

EXPERIMENTAL

Behavioral: Time Restricted Feeding with Calorie Restriction

Control

NO INTERVENTION

Interventions

Calorie Restriction BEHAVIORAL

Participants assigned to this arm to consume food at a caloric deficit of 500 calories per day.

Calorie Restriction

Time Restricted Feeding BEHAVIORAL

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.

Time Restricted Feeding

Time Restricted Feeding with Calorie Restriction BEHAVIORAL

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.

Time Restricted Feeding with Calorie Restriction

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Pregnant or breastfeeding women.
• Diabetics taking insulin or sulfonylureas.
• Smokers.
• History of cardiovascular disease.
• History of psychiatric or eating disorders.
• History of hypoglycemic episodes.

Sponsors & Collaborators

• Usman Bin Hameed: lead
• World Health Organization: collaborator

Study Sites (1)

The Aga Khan University Hospital

Karachi, Sindh, 74800, Pakistan

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Prediabetic State

Interventions

Caloric Restriction

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Energy Intake; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Sarah Nadeem, M.B.B.S, M.D.

  The Aga Khan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 5, 2020
• First Posted: July 9, 2020
• Study Start: September 1, 2020
• Primary Completion: May 15, 2021
• Study Completion: May 15, 2021
• Last Updated: June 8, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)