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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
75
8-h eating window Ad libitum food intake from 12-8 pm every day Fasting from 8-12 pm every day (16-h fast)
25% energy restriction every day Diet counseling provided
University of Illinois Chicago
Chicago, Illinois, United States
Change in percent body weight
Measured by an electronic scale
Time frame: Measured at baseline and month 6
Change in HbA1c
Measured by outside lab (Medstar, IN)
Time frame: Measured at baseline and month 6
Change in total time in euglycemic range
Measured by continuous glucose monitor (CGM)
Time frame: Measured at baseline and month 6
Change in mean glucose level
Measured by continuous glucose monitor (CGM)
Time frame: Measured at baseline and month 6
Change in standard deviation of glucose level
Measured by continuous glucose monitor (CGM)
Time frame: Measured at baseline and month 6
Change fasting glucose
Measured by outside lab (Medstar, IN)
Time frame: Measured at baseline and month 6
Change fasting insulin
Measured by outside lab (Medstar, IN)
Time frame: Measured at baseline and month 6
Change in Insulin sensitivity
Measured as QUICKI
Time frame: Measured at baseline and month 6
Change in insulin resistance
Measured as HOMA-IR
Time frame: Measured at baseline and month 6
Change in absolute body weight
Measured by electronic scale
Time frame: Measured at baseline and month 6
Change in fat mass, lean mass, visceral fat mass
Measured by DXA
Time frame: Measured at baseline and month 6
Change in waist circumference
Measured by measuring tape
Time frame: Measured at baseline and month 6
Change in body mass index (BMI)
Calculated as kg/meter squared
Time frame: Measured at baseline and month 6
Change in plasma lipids (total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides)
Measured by outside lab (Medstar, IN)
Time frame: Measured at baseline and month 6
Change in systolic and diastolic blood pressure
Measured by blood pressure cuff
Time frame: Measured at baseline and month 6
Change in heart rate
Measured by blood pressure cuff
Time frame: Measured at baseline and month 6
Change in energy and nutrient intake
Measured by 7-day food record
Time frame: Measured at baseline and month 6
Change in dietary adherence
Measured by 7-day food record and adherence log
Time frame: Measured at baseline, month 3, and month 6
Change in physical activity (steps/d)
Measured by pedometer
Time frame: Measured at baseline and month 6
Adverse events
Measured by adverse events survey
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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
Time frame: Measured at baseline and month 6
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