Diabetes Mellitus, Type 2NCT05717127
Metabolic Impact of Intermittent Fasting in Early Type 2 Diabetes
A study testing Time restricted feeding and Standard lifestyle in people with Diabetes Mellitus, Type 2 and Obesity, run by Mount Sinai Hospital, Canada at 1 site in Canada.
Trial summary
One known cause of type 2 diabetes (T2DM) is beta-cell dysfunction, which refers to the inability of the beta-cells of the pancreas to produce enough insulin for the body's needs. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Obesity
- What is being tested?
- Time restricted feeding and Standard lifestyle
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2021to 1 Jun 2023
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women with type 2 diabetes mellitus diagnosed within preceding 10 years
- Age 20-70 years inclusive
- Body mass index ≥ 25 kg/m2
- Diabetes treatment consisting of lifestyle only, metformin or dipeptidyl peptidase-4 (DPP-4) inhibitor either as monotherapy or in combination
- HbA1c value of 5.5 - 9.0% inclusive
Who cannot join
- Current diabetes treatment with insulin, glucagon-like peptide-1 receptor agonists, sodium-glucose co-transporter 2 (SGLT-2) and/or sulfonylureas
- Involvements in any other clinical study on lifestyle intervention or requiring drug therapy
- Any history or eating disorder
- Renal dysfunction as evidenced by estimated glomerular filtration rate <45 mL/min by Modification of Diet in Renal Disease (MDRD) formula
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Leadership Sinai Centre foe Diabetes - Mount Sinai Hospital
Toronto, Ontario, M5T 3L9
About this study
One known cause of type 2 diabetes (T2DM) is beta-cell dysfunction, which refers to the inability of the beta-cells of the pancreas to produce enough insulin for the body's needs. Unfortunately, no anti-diabetic medication or lifestyle intervention has been shown to prevent the worsening of beta-cell function over time. Interestingly, however, intermittent fasting (IF) - 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 T2DM, it is also been shown to improve glycemic control (i.e. reduce the sugar levels). While no research has studied whether IF can improve pancreatic beta-cell function, the positive metabolic effects suggest that it could provide some benefit. The current study will evaluate whether IF can improve pancreatic beta-cell function in individuals with early T2DM.
- Conditions
- Diabetes Mellitus, Type 2, Obesity
- Being tested
- Time restricted feeding, Standard lifestyle
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time restricted feedingBehavioural
Restricted feeding with 20 hours of fasting and a 4 hour window of feeding (between 4 and 8 PM or between 5 to 9 PM).
Standard lifestyleBehavioural
Standard lifestyle recommendations
| Study group | Role | What they receive |
|---|---|---|
| Intermittent fasting (time restricted feeding) | Experimental | Intermittent fasting (IF) study arm consisting of time restricted feeding with 20 hours of fasting and a 4 hour window of feeding (between 4 and 8 PM or between 5 to 9 PM). Receives: Behavioral: Time restricted feeding |
| Standard lifestyle | Active comparator | Standard lifestyle recommendation as per the Diabetes Canada guidelines, where participants are encouraged to maintain regularity in timing and spacing of means with no specific recommendations regarding the hours of fasting Receives: Behavioral: Standard lifestyle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pancreatic beta-cell function
The difference in percentage change in beta-cell function between each intervention period, measured using the Insulin Secretion-Sensitivity Index-2 (ISSI-2)
Measured: at week 16
Secondary outcomes (1)
Fasting glucose
Difference in change in fasting glucose between each intervention period
Measured: at week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start1 Sep 2021
- Primary completion1 Jun 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mount Sinai Hospital, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caroline Kramer, Mount Sinai Hospital, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05717127
- Sponsor's protocol ID
- 19-0299-A
- Status last verified
- Jan 2023
- First submitted
- 20 Jan 2023
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kramer CK, Zinman B, Feig DS, Retnakaran R. Effect of Time-Restricted Eating on beta-Cell Function in Adults With Type 2 Diabetes. J Clin Endocrinol Metab. 2025 May 19;110(6):e2045-e2053. doi: 10.1210/clinem/dgae594.
PubMed 39193706Kramer CK, Zinman B, Feig DS, Retnakaran R. The effects of time-restricted eating on energy balance regulation in adults with overweight/obesity and type 2 diabetes. Int J Obes (Lond). 2026 Jun;50(6):1228-1235. doi: 10.1038/s41366-026-02042-1. Epub 2026 Mar 11.
PubMed 41814085
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Impact of Intermittent Fasting in Early Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT05717127
- Acronym / sponsor ID
- 19-0299-A
- Conditions
- Diabetes Mellitus, Type 2, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Mount Sinai Hospital, CanadaUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 8 Feb 2023 (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.
One known cause of type 2 diabetes (T2DM) is beta-cell dysfunction, which refers to the inability of the beta-cells of the pancreas to produce enough insulin for the body's needs. Unfortunately, no anti-diabetic medication or lifestyle intervention has been shown to prevent the worsening of beta-cell function over time. Interestingly, however, intermittent fasting (IF) - 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 T2DM, it is also been shown to improve glycemic control (i.e. reduce the sugar levels). While no research has studied whether IF can improve pancreatic beta-cell function, the positive metabolic effects suggest that it could provide some benefit. The current study will evaluate whether IF can improve pancreatic beta-cell function in individuals with early T2DM.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intermittent fasting (time restricted feeding) | Experimental | Behavioral: Time restricted feedingIntermittent fasting (IF) study arm consisting of time restricted feeding with 20 hours of fasting and a 4 hour window of feeding (between 4 and 8 PM or between 5 to 9 PM). |
| Standard lifestyle | Active comparator | Behavioral: Standard lifestyleStandard lifestyle recommendation as per the Diabetes Canada guidelines, where participants are encouraged to maintain regularity in timing and spacing of means with no specific recommendations regarding the hours of fasting |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men and women with type 2 diabetes mellitus diagnosed within preceding 10 years
- Age 20-70 years inclusive
- Body mass index ≥ 25 kg/m2
- Diabetes treatment consisting of lifestyle only, metformin or dipeptidyl peptidase-4 (DPP-4) inhibitor either as monotherapy or in combination
- HbA1c value of 5.5 - 9.0% inclusive
Key exclusion criteria (7 listed)
- Current diabetes treatment with insulin, glucagon-like peptide-1 receptor agonists, sodium-glucose co-transporter 2 (SGLT-2) and/or sulfonylureas
- Involvements in any other clinical study on lifestyle intervention or requiring drug therapy
- Any history or eating disorder
- Renal dysfunction as evidenced by estimated glomerular filtration rate <45 mL/min by Modification of Diet in Renal Disease (MDRD) formula
- Hepatic disease considered to be clinically significant (includes jaundice, chronic hepatitis, or previous liver transplant) or transaminases >2.5x the upper limit of normal
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 feedingRestricted feeding with 20 hours of fasting and a 4 hour window of feeding (between 4 and 8 PM or between 5 to 9 PM). | Behavioural | Intermittent fasting (time restricted feeding) |
| Standard lifestyleStandard lifestyle recommendations | Behavioural | Standard lifestyle |
Primary outcome
Pancreatic beta-cell function
Time frame: at week 16
The difference in percentage change in beta-cell function between each intervention period, measured using the Insulin Secretion-Sensitivity Index-2 (ISSI-2)
1 secondary outcome
Fasting glucose
Time frame: at week 16
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 3 Oct 2025.
- Results publication: PubMed 39193706Kramer CK, Zinman B, Feig DS, Retnakaran R. Effect of Time-Restricted Eating on beta-Cell Function in Adults With Type 2 Diabetes. J Clin Endocrinol Metab. 2025 May 19;110(6):e2045-e2053. doi: 10.1210/clinem/dgae594.
- Derived from this study: PubMed 41814085Kramer CK, Zinman B, Feig DS, Retnakaran R. The effects of time-restricted eating on energy balance regulation in adults with overweight/obesity and type 2 diabetes. Int J Obes (Lond). 2026 Jun;50(6):1228-1235. doi: 10.1038/s41366-026-02042-1. Epub 2026 Mar 11.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 feeding and Standard lifestyle in people with Diabetes Mellitus, Type 2 and Obesity, 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 7 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 3 Oct 2025. 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?
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?
Pancreatic beta-cell function (time frame: at week 16). 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 NCT05717127, which also lists 2 linked publications.
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 3 Oct 2025.