Diabetes Mellitus, Type 2NCT04463277
A Comparison Between the Effects of Conventional Diets vs Intermittent Fasting Diabetic and Pre-diabetic Patients
A study testing Calorie Restriction, Time Restricted Feeding and Time Restricted Feeding with Calorie Restriction in people with Diabetes Mellitus, Type 2 and PreDiabetes, run by Usman Bin Hameed at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, PreDiabetes
- What is being tested?
- Calorie Restriction, Time Restricted Feeding and Time Restricted Feeding with Calorie Restriction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Sep 2020to 15 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Pregnant or breastfeeding women.
- Diabetics taking insulin or sulfonylureas.
- Smokers.
- History of cardiovascular disease.
- History of psychiatric or eating disorders.
- History of hypoglycemic episodes.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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
- Being tested
- Calorie Restriction, Time Restricted Feeding, Time Restricted Feeding with Calorie Restriction
- Medical subject headings
- Diabetes Mellitus, Type 2, Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calorie RestrictionBehavioural
Participants assigned to this arm to consume food at a caloric deficit of 500 calories per day.
Time Restricted FeedingBehavioural
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 with Calorie RestrictionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Calorie Restriction | Experimental | Not described Receives: Behavioral: Calorie Restriction |
| Time Restricted Feeding | Experimental | Not described Receives: Behavioral: Time Restricted Feeding |
| Time Restricted Feeding with Calorie Restriction | Experimental | Not described Receives: Behavioral: Time Restricted Feeding with Calorie Restriction |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
Change in participants' weight.
Measured: 12 weeks
FBS
Change in participants' fasting plasma glucose levels.
Measured: 12 weeks
HbA1c
Change in percentage of glycated hemoglobin HbA1c in the participants' plasma.
Measured: 12 weeks
OGTT
Change in participants' response to an oral glucose load.
Measured: 12 weeks
Serum Lipid Profile.
Change in participant's serum lipid levels, including cholesterol, LDL, HDL and triglycerides.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2020
- Study start1 Sep 2020
- Primary completion15 May 2021
- Study completion15 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Usman Bin Hameed
- Sponsor type
- University, hospital or other
- Collaborators
- World Health Organization
- Responsible party
- Sponsor-investigator, Usman Bin Hameed, Aga Khan University
- Investigators
- Sarah Nadeem, M.B.B.S, M.D., Principal investigator, The Aga Khan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04463277
- Sponsor's protocol ID
- IFCR-186
- Status last verified
- Jun 2021
- First submitted
- 5 Jul 2020
- Last updated
- 8 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Effects of Time Restricted Feeding and Calorie Restriction in Patients With Prediabetes and Diabetes
- ClinicalTrials.gov ID
- NCT04463277
- Acronym / sponsor ID
- IFCR-186
- Conditions
- Diabetes Mellitus, Type 2, PreDiabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Usman Bin HameedUniversity, hospital or other
- Collaborators
- World Health Organization
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 15 May 2021 (actual)
- Study completion
- 15 May 2021 (actual)
- First posted
- 9 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 | – |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- Pregnant or breastfeeding women.
- Diabetics taking insulin or sulfonylureas.
- Smokers.
- History of cardiovascular disease.
- History of psychiatric or eating disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calorie RestrictionParticipants assigned to this arm to consume food at a caloric deficit of 500 calories per day. | Behavioural | Calorie Restriction |
| Time Restricted FeedingParticipants 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. | Behavioural | Time Restricted Feeding |
| Time Restricted Feeding with Calorie RestrictionParticipants assigned to this arm to consume food at a caloric deficit of 500 calories per day within an 8-hour window during daylight hours. | Behavioural | Time Restricted Feeding with Calorie Restriction |
Primary outcome
Weight
Time frame: 12 weeks
Change in participants' weight.
FBS
Time frame: 12 weeks
Change in participants' fasting plasma glucose levels.
HbA1c
Time frame: 12 weeks
Change in percentage of glycated hemoglobin HbA1c in the participants' plasma.
OGTT
Time frame: 12 weeks
Change in participants' response to an oral glucose load.
Serum Lipid Profile.
Time frame: 12 weeks
Change in participant's serum lipid levels, including cholesterol, LDL, HDL and triglycerides.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah Nadeem, M.B.B.S, M.D. principal investigator
The Aga Khan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calorie Restriction, Time Restricted Feeding and Time Restricted Feeding with Calorie Restriction in people with Diabetes Mellitus, Type 2 and PreDiabetes, run by Usman Bin Hameed at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight (time frame: 12 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2021.