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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Time restricted feeding | Behavioral | 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). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | at week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting glucose | Difference in change in fasting glucose between each intervention period | at week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| BMI | Difference in change in BMI between each intervention period | at week 16 |
| Waist circumference | Difference in change in waist circumference between each intervention period |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Leadership Sinai Centre foe Diabetes - Mount Sinai Hospital | Toronto | Ontario | M5T 3L9 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39193706 | Result | 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. | |
| 41814085 | Derived | Kramer 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. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Standard lifestyle | Behavioral | Standard lifestyle recommendations |
|
| at week 16 |
| Central abdominal fat mass on Dual X-ray Absorptiometry (DEXA) | Difference in change in central abdominal mass between each intervention period | at week 16 |
| Insulin sensitivity | Difference in insulin sensitivity measured by the Matsuda Index between each intervention period | at week 16 |
| Satiety | Difference in hunger assessed by Visual Analogue Scales (0 to 10mm with increased values associated with increased hunger) between each intervention period | at week 16 |
| D004700 | Endocrine System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |