- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04463277
A Comparison Between the Effects of Conventional Diets vs Intermittent Fasting Diabetic and Pre-diabetic Patients
Therapeutic Effects of Time Restricted Feeding and Calorie Restriction in Patients With Prediabetes and Diabetes
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Sindh
-
Karachi, Sindh, Pakistan, 74800
- The Aga Khan University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
NO_INTERVENTION: Control
|
|
EXPERIMENTAL: Calorie Restriction
|
Participants assigned to this arm to consume food at a caloric deficit of 500 calories per day.
|
EXPERIMENTAL: Time Restricted Feeding
|
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.
|
EXPERIMENTAL: Time Restricted Feeding with Calorie Restriction
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Weight
Time Frame: 12 weeks
|
Change in participants' weight.
|
12 weeks
|
FBS
Time Frame: 12 weeks
|
Change in participants' fasting plasma glucose levels.
|
12 weeks
|
HbA1c
Time Frame: 12 weeks
|
Change in percentage of glycated hemoglobin HbA1c in the participants' plasma.
|
12 weeks
|
OGTT
Time Frame: 12 weeks
|
Change in participants' response to an oral glucose load.
|
12 weeks
|
Serum Lipid Profile.
Time Frame: 12 weeks
|
Change in participant's serum lipid levels, including cholesterol, LDL, HDL and triglycerides.
|
12 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Sarah Nadeem, M.B.B.S, M.D., The Aga Khan University Hospital
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IFCR-186
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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