Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Innovative lifestyle strategies to treat type 2 diabetes (T2DM) are critically needed. At present, daily calorie restriction (CR) is the main diet prescribed to patients with T2DM for weight loss. However, many patients find it difficult to adhere to CR because calorie intake must be vigilantly monitored every day.
In light of these problems with CR, another approach that limits timing of food intake, instead of number of calories consumed, has been developed. This diet is called "time restricted eating" (TRE) and involves confining the period of food intake to 6-8 h per day. TRE allows individuals to self-select foods and eat ad libitum during a large part of the day, which greatly increases compliance to these protocols. Recent findings show that TRE is effective for weight loss and improved glycemic control in patients with obesity and prediabetes. However no long-term randomized controlled trial has examined whether TRE is safe and effective for patients with obesity and T2DM.
This study is a 6-month randomized, controlled trial that aims to compare the effects of TRE (eating all food between 12:00 pm to 8:00 pm, without calorie counting), versus CR (25% energy restriction daily), and a control group eating over a period of 10 or more hours per day, on change in body weight (%), glycemic control, and cardiometabolic risk factors, in adults with obesity and T2DM.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Time restricted feeding (TRF) | Experimental | 8-h eating window Ad libitum food intake from 12-8 pm every day Fasting from 8-12 pm every day (16-h fast) |
|
| Daily calorie restriction (CR) | Experimental | 25% energy restriction every day Diet counseling provided |
|
| Control | No Intervention | Ad libitum food intake, eating over more than 10 hours per day |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Time restricted feeding (TRF) | Other | 8-h eating window Ad libitum food intake from 12-8 pm every day Fasting from 8-12 pm every day (16-h fast) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in percent body weight | Measured by an electronic scale | Measured at baseline and month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c | Measured by outside lab (Medstar, IN) | Measured at baseline and month 6 |
| Change in total time in euglycemic range | Measured by continuous glucose monitor (CGM) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Krista Varady | University of Illinois at Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Illinois Chicago | Chicago | Illinois | 60612 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37889487 | Derived | Pavlou V, Cienfuegos S, Lin S, Ezpeleta M, Ready K, Corapi S, Wu J, Lopez J, Gabel K, Tussing-Humphreys L, Oddo VM, Alexandria SJ, Sanchez J, Unterman T, Chow LS, Vidmar AP, Varady KA. Effect of Time-Restricted Eating on Weight Loss in Adults With Type 2 Diabetes: A Randomized Clinical Trial. JAMA Netw Open. 2023 Oct 2;6(10):e2339337. doi: 10.1001/jamanetworkopen.2023.39337. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Daily calorie restriction | Other | 25% energy restriction every day Diet counseling provided |
|
| Measured at baseline and month 6 |
| Change in mean glucose level | Measured by continuous glucose monitor (CGM) | Measured at baseline and month 6 |
| Change in standard deviation of glucose level | Measured by continuous glucose monitor (CGM) | Measured at baseline and month 6 |
| Change fasting glucose | Measured by outside lab (Medstar, IN) | Measured at baseline and month 6 |
| Change fasting insulin | Measured by outside lab (Medstar, IN) | Measured at baseline and month 6 |
| Change in Insulin sensitivity | Measured as QUICKI | Measured at baseline and month 6 |
| Change in insulin resistance | Measured as HOMA-IR | Measured at baseline and month 6 |
| Change in absolute body weight | Measured by electronic scale | Measured at baseline and month 6 |
| Change in fat mass, lean mass, visceral fat mass | Measured by DXA | Measured at baseline and month 6 |
| Change in waist circumference | Measured by measuring tape | Measured at baseline and month 6 |
| Change in body mass index (BMI) | Calculated as kg/meter squared | Measured at baseline and month 6 |
| Change in plasma lipids (total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides) | Measured by outside lab (Medstar, IN) | Measured at baseline and month 6 |
| Change in systolic and diastolic blood pressure | Measured by blood pressure cuff | Measured at baseline and month 6 |
| Change in heart rate | Measured by blood pressure cuff | Measured at baseline and month 6 |
| Change in energy and nutrient intake | Measured by 7-day food record | Measured at baseline and month 6 |
| Change in dietary adherence | Measured by 7-day food record and adherence log | Measured at baseline, month 3, and month 6 |
| Change in physical activity (steps/d) | Measured by pedometer | Measured at baseline and month 6 |
| Adverse events | Measured by adverse events survey | Measured weekly from baseline to month 6 |
| Change in medication effect score (MES) | Measured by survey. Total score 0-100. Lower scores indicate less medication used, higher scores indicate more medication used. | Measured at baseline and month 6 |
| Change in sleep quality | Measured by Pittsburgh Sleep Quality Index (PSQI), total score of 0-21. A PSQI total score greater than 5 indicates poor sleep quality. | Measured at baseline and month 6 |
| Change in insomnia severity | Measured by Insomnia Severity Index (ISI), total score of 0-28. The total score for the ISI is interpreted as follows: no clinically significant insomnia (0-7), sub-threshold insomnia (8-14), moderate severity insomnia (15-21), and severe insomnia (22-28). | Measured at baseline and month 6 |
| Change in risk of sleep apnea | Measured by Berlin Questionnaire, measures proportion of participants at high risk for sleep apnea | Measured at baseline and month 6 |
| D004700 | Endocrine System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |