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

Primary Purpose

Diabetes Mellitus, Type 2, PreDiabetes

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Calorie Restriction
Time Restricted Feeding
Time Restricted Feeding with Calorie Restriction
Sponsored by
Usman Bin Hameed
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Aga Khan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

Calorie Restriction

Time Restricted Feeding

Time Restricted Feeding with Calorie Restriction

Control

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
July 5, 2020
Last Updated
June 6, 2021
Sponsor
Usman Bin Hameed
Collaborators
World Health Organization
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1. Study Identification

Unique Protocol Identification Number
NCT04463277
Brief Title
A Comparison Between the Effects of Conventional Diets vs Intermittent Fasting Diabetic and Pre-diabetic Patients
Official Title
Therapeutic Effects of Time Restricted Feeding and Calorie Restriction in Patients With Prediabetes and Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
May 15, 2021 (Actual)
Study Completion Date
May 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Usman Bin Hameed
Collaborators
World Health Organization

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, PreDiabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
128 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Calorie Restriction
Arm Type
Experimental
Arm Title
Time Restricted Feeding
Arm Type
Experimental
Arm Title
Time Restricted Feeding with Calorie Restriction
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Calorie Restriction
Intervention Description
Participants assigned to this arm to consume food at a caloric deficit of 500 calories per day.
Intervention Type
Behavioral
Intervention Name(s)
Time Restricted Feeding
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Time Restricted Feeding with Calorie Restriction
Intervention Description
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.
Primary Outcome Measure Information:
Title
Weight
Description
Change in participants' weight.
Time Frame
12 weeks
Title
FBS
Description
Change in participants' fasting plasma glucose levels.
Time Frame
12 weeks
Title
HbA1c
Description
Change in percentage of glycated hemoglobin HbA1c in the participants' plasma.
Time Frame
12 weeks
Title
OGTT
Description
Change in participants' response to an oral glucose load.
Time Frame
12 weeks
Title
Serum Lipid Profile.
Description
Change in participant's serum lipid levels, including cholesterol, LDL, HDL and triglycerides.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah Nadeem, M.B.B.S, M.D.
Organizational Affiliation
The Aga Khan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Aga Khan University Hospital
City
Karachi
State/Province
Sindh
ZIP/Postal Code
74800
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

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

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