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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Standard lifestyle | Active Comparator | Standard lifestyle recommendation as per Diabetes Canada Guidelines. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Time-restricted eating | Behavioral | 18 hours of fasting and 6 hour window of eating (between 2 to 8 PM) every day for 52 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 52-weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Differences in baseline-adjusted insulin resistance between the study groups | Baseline-adjusted insulin resistance at 52-weeks measured by HOMA-IR | 52-weeks |
| Differences in time in glucose target range between each study group |
| Measure | Description | Time Frame |
|---|---|---|
| Anthropometric measures | Differences in body weight (kg) between each study arm | 52-weeks |
| Additional measures of beta-cell function | Insulinogenic index/HOMA-IR. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Caroline K Kramer, MD, PhD | Contact | +1-416-586-4800 | 7628 | Caroline.Kramer@sinaihealth.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Leadership Sinai Centre for Diabetes | Recruiting | Toronto | Ontario | M5T3L9 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41818195 | Derived | 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. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D050177 | Overweight |
| D000093763 | Intermittent Fasting |
| 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 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] |
|
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.
| 52-weeks |
| 52-weeks |
| Additional measures of insulin sensitivity | Matsuda Index | 52-weeks |
| Time above glucose target on isCGM | Differences between each study arm in time-above target of 10 mmol/l (%) obtained by isCGM (FreeStyle Libre devices). | 52 weeks |
| Additional anthropometric measures | Differences in waist circumference between the study arms | 52 weeks |
| D004700 | Endocrine System Diseases |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005215 | Fasting |
| D005247 | Feeding Behavior |
| D001519 | Behavior |