Time Restricted Eating for the Treatment of Type 2 Diabetes

Study Overview
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Brief Summary
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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.

Official Title
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Time Restricted Eating for the Treatment of Type 2 Diabetes

Conditions
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Diabetes Mellitus, Type 2, Obesity

Intervention / Treatment
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* Other: Time restricted feeding (TRF)
* Other: Daily calorie restriction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-80 years BMI between 30 and 50 kg/m2 Previously diagnosed with type 2 diabetes HbA1c between 6.5 and 11% Sedentary or lightly active Exclusion Criteria: HbA1c below 6.5 or greater than 11% Have a history of cardiovascular disease History of eating disorders (anorexia, bulimia, or binge eating disorder) Not weight stable for 3 months prior to the beginning of study (weight gain or loss > 4%) Eating within less than a 10 hour window at baseline Perimenopausal (menses does not appear every 27-32d) Pregnant, or trying to become pregnant Night shift workers Smokers

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Time restricted feeding (TRF)<br>8-h eating window Ad libitum food intake from 12-8 pm every day Fasting from 8-12 pm every day (16-h fast) | Other: Time restricted feeding (TRF)<br>* 8-h eating window Ad libitum food intake from 12-8 pm every day Fasting from 8-12 pm every day (16-h fast)<br>|
| Experimental: Daily calorie restriction (CR)<br>25% energy restriction every day Diet counseling provided | Other: Daily calorie restriction<br>* 25% energy restriction every day Diet counseling provided<br>|
| No Intervention: Control<br>Ad libitum food intake, eating over more than 10 hours per day | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in percent body weight | Measured by an electronic scale | Measured at baseline and month 6 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 |