Diabetes Mellitus, Type 2NCT04062773
Time-Restricted Feeding on Glucose Homeostasis and Quality of Life
A study testing TRF and Normal timing of food intake in people with Diabetes Mellitus, Type 2 and Time Restricted Feeding, run by Dasman Diabetes Institute at 1 site in Kuwait.
Trial summary
Background: Time-restricted feeding can improve insulin sensitivity, and increase fat oxidation in people with prediabetes independent of weight loss. It may also help people to lose weight. However, it has not been tested in people with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Time Restricted Feeding
- What is being tested?
- TRF and Normal timing of food intake
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteKuwait
- Study dates
- 10 Jul 2019to 1 Mar 2020
- 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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must agree to follow time restricted feeding protocol if randomized to the TRF arm.
- Age 21-65 years
- T2DM with any diabetes medication
- BMI of 25-45 kg/m2
- Wake up at a regular time between 5-8 am
- Able to provide informed consent.
Who cannot join
- Weight loss of more than 5 kg within the past 6 months
- HbA1c of <6·5% and >12%
- Serious current or recent illness including cancer or severe or unstable heart failure.
- Participation in another clinical research trial.
- Current treatment with anti-obesity drugs.
- Substance abuse
Show all 13Show fewer
- Learning difficulties
- Presence of an eating disorder
- Purging behaviour
- Pregnancy or consideration of pregnancy
- Hospital admission for depression or use of antipsychotic drugs.
- Regularly eat within a <9-hour period each day
- Inability or unwillingness of individual or legal guardian/representative to give written informed consent.
Trial locations and contacts
1 site in 1 country.
Kuwait1 site, 1 recruiting
- Recruiting
Dasman Diabetes Institute
Kuwait City, 15462
Nicola Guess, PhD, +965 2224 2999 ext. 2033, Nicola.Guess@dasmaninstitute.org
About this study
Official title: A Pilot Study to Evaluate the Effect of Time-Restricted Feeding on Blood Glucose, Insulin Sensitivity and Quality of Life
Background: Time-restricted feeding can improve insulin sensitivity, and increase fat oxidation in people with prediabetes independent of weight loss. It may also help people to lose weight. However, it has not been tested in people with type 2 diabetes.
Plan of investigation: Participants meeting the eligibility criteria will be randomized to the TRF arm or the continuous eating arm. Both arms with be given a prescribed dietary plan to help them lose 5% of body weight. In the TRF they will permitted to eat between midday and 6pm. In the continuous eating arm they will be allowed to eat between 8am and 11pm. Participants will attend the nutrition clinic every two weeks to be weighed and be given personalized support to help them follow their assigned diet. Prior to starting the diets outcome measures will be taken: Glycaemia will be measured by a glucose tolerance test, and 7-day continuous glucose monitoring. HbA1c will be taken from fasting blood sample. In addition, the fasting sample will be taken for measurement of insulin, lipid profile and inflammatory markers. We will also use questionnaires to assess quality of life, a 3-day food diary to assess compliance to diet especially meal timings. Capillary ketones will also be used to assess whether compliance to the assigned fasting period. Outcome measures will also be taken during 7 days of the second month, and then the final seven days of the last month on the diet. The primary outcome is HbA1c.
Read the detailed description
Experimental Design
12-week parallel randomised control trial
Recruitment
We will recruit via advertisements outside Dasman using social media and local ads in addition to screening of Dasman Registry for any potential participants. Opportunistic recruitment will also occur by DDI dietitians. Following telephone screening to ensure the potential participant meets initial screening criteria we will carry out a medical screening to ensure the person can take part.
Environment All screening, dietary counselling visits, and placement of the CGM will take place at the Dasman Diabetes Institute (DDI). The institute has extensive space for interventional studies, including screening rooms, body composition assessment and clinical rooms for placement of the CGM monitor.
STUDY INTERVENTIONS
For both groups all participants will be guided towards a 5% weight loss based on individualised energy requirements. The difference will be the hours during which the participants consume their required calories.
- Time restricted feeding group: Will consume their calories between 12pm and 6pm.
- Continuous energy restriction group: Will consume their calories between 8am and 11pm.
Participants will be guided towards their weight loss during one-to-one visits at baseline and every 2 weeks for 12 weeks.
Procedures
- At baseline and follow-up all participants will undergo an oral glucose tolerance test.
- A blood sample will also be taken for HbA1c, lipid profile, fasting insulin, inflammatory factors and a sample for Biobank. The biobank sample will be stored to enable us, with other researchers at DDI to understand the heterogeneity of type 2 diabetes; whether certain people respond to dietary interventions based on their genetic, epigenetic or metabolomic background; and ultimately will help guide clinical care.
- Participants will wear Flash Glucose monitoring or other continuous glucose monitoring device to measure their 24-hour blood glucose concentrations during the seven days preceding the start of the dietary intervention, seven days of the second month, and the final seven days of the third month.
- Participants will also measure their capillary ketones during the first three days of the first month, three days of the second month, and final three days of the third month.
- Medication changes: prandial medications (insulin or sulphonylurea) will be altered to the timing of meal intake. Any reduction in medication due to changes in glucose will be carried out by the patient's doctor.
- A quality of life questionnaire: PAID.
- A 3 day food diary with meal times to check compliance.
Statistical Methods
This is a pilot study. We will recruit 25 people per group. This is based on recommendations for sample sizes for feasibility and pilot studies.
- Conditions
- Diabetes Mellitus, Type 2, Time Restricted Feeding
- Being tested
- TRF, Normal timing of food intake
- Medical subject headings
- Diabetes Mellitus, Type 2, Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRFBehavioural
time restricted feeding group
Normal timing of food intakeBehavioural
no time restricted feeding
| Study group | Role | What they receive |
|---|---|---|
| TRF | Experimental | Eating restricted to between midday and 6pm. Receives: Behavioral: TRF |
| Normal timing of food intake. | Placebo comparator | Eating between 8am and 11pm. Receives: Behavioral: Normal timing of food intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Change in HbA1c between the intervention and control arms.
Measured: 12 weeks
Secondary outcomes (9)
Body weight
Change in body weight between the intervention and control arms.
Measured: 12 weeks
Insulin sensitivity
Change insulin sensitivitiy assessed by OGTT between the intervention and control arms.
Measured: 12 weeks
Diabetes medications
Change in diabetes medications between the intervention and control arms.
Measured: 12 weeks
Inflammatory markers
Change in TNF-alpha in pg/mL between the intervention and control arms.
Measured: 12 weeks
Inflammatory markers
Change in IL-10 in pg/mL between the intervention and control arms.
Measured: 12 weeks
Inflammatory markers
Change in IL-6 in pg/mL between the intervention and control arms.
Measured: 12 weeks
Inflammatory markers
Change in IL-18 in pg/mL between the intervention and control arms.
Measured: 12 weeks
Inflammatory markers
Change in CRP in mg/L between the intervention and control arms.
Measured: 12 weeks
Inflammatory markers
Change in adiponectin in µg/mL the intervention and control arms.
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 posted20 Aug 2019
- Study start10 Jul 2019
- Primary completion1 Mar 2020 (estimated)
- Study completion1 Mar 2020 (estimated)
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
- Model description
- 12 week parallel trial.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dasman Diabetes Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Ebaa Al Ozairi, Dasman Diabetes Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04062773
- Sponsor's protocol ID
- RA HM-2019-012
- Status last verified
- Dec 2019
- First submitted
- 18 Aug 2019
- Last updated
- 13 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate the Effect of Time-Restricted Feeding on Blood Glucose, Insulin Sensitivity and Quality of Life
- ClinicalTrials.gov ID
- NCT04062773
- Acronym / sponsor ID
- RA HM-2019-012
- Conditions
- Diabetes Mellitus, Type 2, Time Restricted Feeding
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Dasman Diabetes InstituteUniversity, hospital or other
- Study start
- 10 Jul 2019 (actual)
- Primary completion
- 1 Mar 2020 (estimated)
- Study completion
- 1 Mar 2020 (estimated)
- First posted
- 20 Aug 2019 (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.
Background: Time-restricted feeding can improve insulin sensitivity, and increase fat oxidation in people with prediabetes independent of weight loss. It may also help people to lose weight. However, it has not been tested in people with type 2 diabetes.
Plan of investigation: Participants meeting the eligibility criteria will be randomized to the TRF arm or the continuous eating arm. Both arms with be given a prescribed dietary plan to help them lose 5% of body weight. In the TRF they will permitted to eat between midday and 6pm. In the continuous eating arm they will be allowed to eat between 8am and 11pm. Participants will attend the nutrition clinic every two weeks to be weighed and be given personalized support to help them follow their assigned diet. Prior to starting the diets outcome measures will be taken: Glycaemia will be measured by a glucose tolerance test, and 7-day continuous glucose monitoring. HbA1c will be taken from fasting blood sample. In addition, the fasting sample will be taken for measurement of insulin, lipid profile and inflammatory markers. We will also use questionnaires to assess quality of life, a 3-day food diary to assess compliance to diet especially meal timings. Capillary ketones will also be used to assess whether compliance to the assigned fasting period. Outcome measures will also be taken during 7 days of the second month, and then the final seven days of the last month on the diet. The primary outcome is HbA1c.
Detailed description
Experimental Design
12-week parallel randomised control trial
Recruitment
We will recruit via advertisements outside Dasman using social media and local ads in addition to screening of Dasman Registry for any potential participants. Opportunistic recruitment will also occur by DDI dietitians. Following telephone screening to ensure the potential participant meets initial screening criteria we will carry out a medical screening to ensure the person can take part.
Environment All screening, dietary counselling visits, and placement of the CGM will take place at the Dasman Diabetes Institute (DDI). The institute has extensive space for interventional studies, including screening rooms, body composition assessment and clinical rooms for placement of the CGM monitor.
STUDY INTERVENTIONS
For both groups all participants will be guided towards a 5% weight loss based on individualised energy requirements. The difference will be the hours during which the participants consume their required calories.
- Time restricted feeding group: Will consume their calories between 12pm and 6pm.
- Continuous energy restriction group: Will consume their calories between 8am and 11pm.
Participants will be guided towards their weight loss during one-to-one visits at baseline and every 2 weeks for 12 weeks.
Procedures
- At baseline and follow-up all participants will undergo an oral glucose tolerance test.
- A blood sample will also be taken for HbA1c, lipid profile, fasting insulin, inflammatory factors and a sample for Biobank. The biobank sample will be stored to enable us, with other researchers at DDI to understand the heterogeneity of type 2 diabetes; whether certain people respond to dietary interventions based on their genetic, epigenetic or metabolomic background; and ultimately will help guide clinical care.
- Participants will wear Flash Glucose monitoring or other continuous glucose monitoring device to measure their 24-hour blood glucose concentrations during the seven days preceding the start of the dietary intervention, seven days of the second month, and the final seven days of the third month.
- Participants will also measure their capillary ketones during the first three days of the first month, three days of the second month, and final three days of the third month.
- Medication changes: prandial medications (insulin or sulphonylurea) will be altered to the timing of meal intake. Any reduction in medication due to changes in glucose will be carried out by the patient's doctor.
- A quality of life questionnaire: PAID.
- A 3 day food diary with meal times to check compliance.
Statistical Methods
This is a pilot study. We will recruit 25 people per group. This is based on recommendations for sample sizes for feasibility and pilot studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 12 week parallel trial.
| Arm | Type | Receives |
|---|---|---|
| TRF | Experimental | Behavioral: TRFEating restricted to between midday and 6pm. |
| Normal timing of food intake. | Placebo comparator | Behavioral: Normal timing of food intakeEating between 8am and 11pm. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Must agree to follow time restricted feeding protocol if randomized to the TRF arm.
- Age 21-65 years
- T2DM with any diabetes medication
- BMI of 25-45 kg/m2
- Wake up at a regular time between 5-8 am
Key exclusion criteria (13 listed)
- Weight loss of more than 5 kg within the past 6 months
- HbA1c of <6·5% and >12%
- Serious current or recent illness including cancer or severe or unstable heart failure.
- Participation in another clinical research trial.
- Current treatment with anti-obesity drugs.
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 |
|---|---|---|
| TRFtime restricted feeding group | Behavioural | TRF |
| Normal timing of food intakeno time restricted feeding | Behavioural | Normal timing of food intake. |
Primary outcome
HbA1c
Time frame: 12 weeks
Change in HbA1c between the intervention and control arms.
9 secondary outcomes
Body weight
Time frame: 12 weeks
Insulin sensitivity
Time frame: 12 weeks
Diabetes medications
Time frame: 12 weeks
Inflammatory markers
Time frame: 12 weeks
Inflammatory markers
Time frame: 12 weeks
Inflammatory markers
Time frame: 12 weeks
Inflammatory markers
Time frame: 12 weeks
Inflammatory markers
Time frame: 12 weeks
Inflammatory markers
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2019.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TRF and Normal timing of food intake in people with Diabetes Mellitus, Type 2 and Time Restricted Feeding, run by Dasman Diabetes Institute at 1 site in Kuwait.
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 6 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 13 Dec 2019. 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 Kuwait. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nicola Guess, PhD (+965 2224 2999 ext. 2033, Nicola.Guess@dasmaninstitute.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c (time frame: 12 weeks). 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 13 Dec 2019.