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The majority of adults with type 1 diabetes (T1DM) have either overweight or obesity. As such, dietary management has been recommended as an adjunct to insulin treatment to improve glycemic control and facilitate weight loss in patients with T1DM. Daily calorie restriction (CR) is the main diet prescribed to patients with T1DM 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. The simplicity of TRE, its accommodation of dietary preferences, and associated weight loss may translate to improved glycemic measures in patients with T1DM. The present study will be the first randomized controlled trial to compare the effect of TRE versus CR for weight management and improved glycemic control in adults with obesity and T1DM.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Time restricted eating (TRE) | 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 eating | 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 ELISA | Measured at baseline and month 6 |
| Change in total time in euglycemic range | Measured by continuous glucose monitor (CGM) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Krista Varady, PhD | University of Illinois at Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Illinois Chicago | Chicago | Illinois | 60612 | United States |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| 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 in coefficient of variation of glucose level | Measured by continuous glucose monitor (CGM) | Measured at baseline and month 6 |
| Change in absolute body weight | Measured by an 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 using enzymatic kits, standardized reagents, and standardsand analyzed using a microplate reader | 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 and month 6 |
| Change in physical activity (steps/d) | Measured by activity monitor | Measured at baseline and month 6 |
| Adverse events | Measured by adverse events survey and continous glucose monitor (for events of hypoglycemia and hyperglycemia) | Measured at baseline and month 6 |
| Change in insulin dose | Measured by recording total insulin dose, basal insulin dose, and bolus insulin dose | Measured at baseline and month 6 |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |