Type 2 DiabetesTEA-TIMENCT07272460
Time Restricted-EAting for Type 2 Diabetes and MEtabolic Health: the TEA TIME Trial
A study testing Time-restricted eating and Standard lifestyle in people with Type 2 Diabetes and Overweight (BMI > 25), run by Mount Sinai Hospital, Canada at 1 site in Canada.
Trial summary
Time-restricted eating - where no food is consumed over a period of time - has been shown to promote weight loss and improve cardio-metabolic function. In individuals with type 2 diabetes, it is also been shown to improve glucose control. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes, Overweight (BMI > 25)
- What is being tested?
- Time-restricted eating and Standard lifestyle
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteCanada
- Study dates
- 1 Feb 2026to 31 Jul 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals with previously diagnosed BMI ≥ 25 kg/m2 and type 2 diabetes within preceding 10 years.
- Age 18 - 75 years inclusive
- Stable weight over past 12 weeks (less than 5% change in body weight) (self-reported)
- Diabetes treatment consisting of lifestyle only or metformin, dipeptidyl peptidase-4 (DPP-4) inhibitor, and sodium-glucose co-transporter 2 (SGLT2) inhibitors either as monotherapy or in combination.
- Ability to read and understand English
Who cannot join
- Current diabetes treatment with insulin, glucagon-like peptide-1 receptor agonists, and/or sulfonylureas.
- Use of any other pharmacological treatment for weight-loss
- Previous surgical treatment for weight loss such as gastric bypass or gastric band
- Any history of eating disorder
- Currently pregnant or lactating
- Renal dysfunction as evidenced by estimated glomerular filtration rate < 25 ml/min by CKD-EPI Creatinine Equation
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- New York Heart Association class II-IV heart failure
- Hepatic disease considered to be clinically significant (includes jaundice, chronic hepatitis, or previous liver transplant) or transaminases >2.5X the upper limit of normal
- Malignant neoplasm requiring chemotherapy, surgery, radiation or palliative therapy within the previous 5 years (with the exception of basal cell skin cancer)
- Any other factor likely to limit adherence to the study, in the opinion of the investigators
- Concurrent participation in another research study relevant to diabetes and metabolic health
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Leadership Sinai Centre for Diabetes
Toronto, Ontario, M5T3L9
Kramer, +1416-586-4800 ext. 7628, Caroline.Kramer@sinaihealth.ca
About this study
Official title: Time Restricted-eating and Metabolic Health in Patients With Type 2 Diabetes
Time-restricted eating - where no food is consumed over a period of time - has been shown to promote weight loss and improve cardio-metabolic function. In individuals with type 2 diabetes, it is also been shown to improve glucose control. The investigators propose a randomized controlled trial to determine whether time-restricted eating is an effective therapeutic strategy that can preserve pancreatic beta-cell function and improve glycemic control early in participants with type 2 diabetes.
Read the detailed description
In this study, eligible patients with type 2 diabetes will be randomized to either time-restricted eating or standard lifestyle. The hypothesis under study is whether time-restricted eating can improve pancreatic beta-cell function.
- Conditions
- Type 2 Diabetes, Overweight (BMI > 25)
- Being tested
- Time-restricted eating, Standard lifestyle
- Keywords
- Randomized controlled trial, Time-restricted eating, Intermittent fasting, Type 2 diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2, Overweight, Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time-restricted eatingBehavioural
18 hours of fasting and 6 hour window of eating (between 2 to 8 PM) every day for 52 weeks.
Standard lifestyleBehavioural
standard lifestyle recommendations as per Diabetes Canada guidelines [where patients are encouraged to maintain regularity in timing and spacing of meals with no specific recommendation regarding hours of fasting]
| Study group | Role | What they receive |
|---|---|---|
| Time-restricted eating | Experimental | Time-restricted eating protocol consisting of time-restricted eating with 18 hours of fasting and 6 hour window of eating (between 2 to 8 PM) every day. Receives: Behavioral: Time-restricted eating |
| Standard lifestyle | Active comparator | Standard lifestyle recommendation as per Diabetes Canada Guidelines. Receives: Behavioral: Standard lifestyle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in baseline-adjusted Insulin-Secretion-Sensitivity Index-2 (ISSI-2) between the study groups.
Baseline-adjusted beta-cell function at 52 weeks, measured by Insulin Secretion-Sensitivity Index-2 (ISSI-2).
Measured: 52-weeks
Secondary outcomes (2)
Differences in baseline-adjusted insulin resistance between the study groups
Baseline-adjusted insulin resistance at 52-weeks measured by HOMA-IR
Measured: 52-weeks
Differences in time in glucose target range between each study group
Time in glucose target range indicates the amount of time (in %) that glucose readings are within the defined target glucose range of 3.9-10.0 mmol/L.
Measured: 52-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start1 Feb 2026
- Primary completion30 Mar 2029 (estimated)
- Study completion31 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies 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
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mount Sinai Hospital, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07272460
- Sponsor's protocol ID
- REB # 0002
- Acronym
- TEA-TIME
- Status last verified
- Sep 2025
- First submitted
- 29 Sep 2025
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Retnakaran M, Lessa VL, Kramer CK. Time restricted EAting for Type 2 diabetes and MEtabolic health: The TEA TIME trial study protocol. PLoS One. 2026 Mar 12;21(3):e0343494. doi: 10.1371/journal.pone.0343494. eCollection 2026.
PubMed 41818195
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time Restricted-eating and Metabolic Health in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT07272460
- Acronym / sponsor ID
- TEA-TIME / REB # 0002
- Conditions
- Type 2 Diabetes, Overweight (BMI > 25)
- Keywords
- Randomized controlled trial, Time-restricted eating, Intermittent fasting, Type 2 diabetes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Mount Sinai Hospital, CanadaUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 30 Mar 2029 (estimated)
- Study completion
- 31 Jul 2029 (estimated)
- First posted
- 9 Dec 2025 (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.
Time-restricted eating - where no food is consumed over a period of time - has been shown to promote weight loss and improve cardio-metabolic function. In individuals with type 2 diabetes, it is also been shown to improve glucose control. The investigators propose a randomized controlled trial to determine whether time-restricted eating is an effective therapeutic strategy that can preserve pancreatic beta-cell function and improve glycemic control early in participants with type 2 diabetes.
Detailed description
In this study, eligible patients with type 2 diabetes will be randomized to either time-restricted eating or standard lifestyle. The hypothesis under study is whether time-restricted eating can improve pancreatic beta-cell function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Time-restricted eating | Experimental | Behavioral: Time-restricted eatingTime-restricted eating protocol consisting of time-restricted eating with 18 hours of fasting and 6 hour window of eating (between 2 to 8 PM) every day. |
| Standard lifestyle | Active comparator | Behavioral: Standard lifestyleStandard lifestyle recommendation as per Diabetes Canada Guidelines. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Individuals with previously diagnosed BMI ≥ 25 kg/m2 and type 2 diabetes within preceding 10 years.
- Age 18 - 75 years inclusive
- Stable weight over past 12 weeks (less than 5% change in body weight) (self-reported)
- Diabetes treatment consisting of lifestyle only or metformin, dipeptidyl peptidase-4 (DPP-4) inhibitor, and sodium-glucose co-transporter 2 (SGLT2) inhibitors either as monotherapy or in combination.
- Ability to read and understand English
Key exclusion criteria (11 listed)
- Current diabetes treatment with insulin, glucagon-like peptide-1 receptor agonists, and/or sulfonylureas.
- Use of any other pharmacological treatment for weight-loss
- Previous surgical treatment for weight loss such as gastric bypass or gastric band
- Any history of eating disorder
- Currently pregnant or lactating
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 |
|---|---|---|
| Time-restricted eating18 hours of fasting and 6 hour window of eating (between 2 to 8 PM) every day for 52 weeks. | Behavioural | Time-restricted eating |
| Standard lifestylestandard lifestyle recommendations as per Diabetes Canada guidelines [where patients are encouraged to maintain regularity in timing and spacing of meals with no specific recommendation regarding hours of fasting] | Behavioural | Standard lifestyle |
Primary outcome
Differences in baseline-adjusted Insulin-Secretion-Sensitivity Index-2 (ISSI-2) between the study groups.
Time frame: 52-weeks
Baseline-adjusted beta-cell function at 52 weeks, measured by Insulin Secretion-Sensitivity Index-2 (ISSI-2).
2 secondary outcomes
Differences in baseline-adjusted insulin resistance between the study groups
Time frame: 52-weeks
Differences in time in glucose target range between each study group
Time frame: 52-weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
- Derived from this study: PubMed 41818195Retnakaran M, Lessa VL, Kramer CK. Time restricted EAting for Type 2 diabetes and MEtabolic health: The TEA TIME trial study protocol. PLoS One. 2026 Mar 12;21(3):e0343494. doi: 10.1371/journal.pone.0343494. eCollection 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Time-restricted eating and Standard lifestyle in people with Type 2 Diabetes and Overweight (BMI > 25), run by Mount Sinai Hospital, Canada at 1 site in Canada.
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 5 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 11 Feb 2026. 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 Canada. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Caroline K Kramer, MD, PhD (+1-416-586-4800 ext. 7628, Caroline.Kramer@sinaihealth.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in baseline-adjusted Insulin-Secretion-Sensitivity Index-2 (ISSI-2) between the study groups. (time frame: 52-weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07272460, which also lists 1 linked publication.
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 11 Feb 2026.