Clinical trial NCT05225337: Time Restricted Eating for the Treatment of Type 2 Diabetes
Official title: Time Restricted Eating for the Treatment of Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Obesity
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
First posted: 2022-02-04
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in percent body weight
timeFrame: Measured at baseline and month 6
Secondary outcomes:
measure: Change in HbA1c
timeFrame: Measured at baseline and month 6
measure: Change in total time in euglycemic range
timeFrame: Measured at baseline and month 6
measure: Change in mean glucose level
timeFrame: Measured at baseline and month 6
measure: Change in standard deviation of glucose level
timeFrame: Measured at baseline and month 6
measure: Change fasting glucose
timeFrame: Measured at baseline and month 6
measure: Change fasting insulin
timeFrame: Measured at baseline and month 6
measure: Change in Insulin sensitivity
timeFrame: Measured at baseline and month 6
measure: Change in insulin resistance
timeFrame: Measured at baseline and month 6
measure: Change in absolute body weight
timeFrame: Measured at baseline and month 6
measure: Change in fat mass, lean mass, visceral fat mass
timeFrame: Measured at baseline and month 6
measure: Change in waist circumference
timeFrame: Measured at baseline and month 6
measure: Change in body mass index (BMI)
timeFrame: Measured at baseline and month 6
measure: Change in plasma lipids (total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides)
timeFrame: Measured at baseline and month 6
measure: Change in systolic and diastolic blood pressure
timeFrame: Measured at baseline and month 6
measure: Change in heart rate
timeFrame: Measured at baseline and month 6
measure: Change in energy and nutrient intake
timeFrame: Measured at baseline and month 6
measure: Change in dietary adherence
timeFrame: Measured at baseline, month 3, and month 6
measure: Change in physical activity (steps/d)
timeFrame: Measured at baseline and month 6
measure: Adverse events
timeFrame: Measured weekly from baseline to month 6
measure: Change in medication effect score (MES)
timeFrame: Measured at baseline and month 6
measure: Change in sleep quality
timeFrame: Measured at baseline and month 6
measure: Change in insomnia severity
timeFrame: Measured at baseline and month 6
measure: Change in risk of sleep apnea
timeFrame: Measured at baseline and month 6
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois Chicago
state: Illinois
Study officials:
affiliation: University of Illinois Chicago
name: Krista Varady
role: PRINCIPAL_INVESTIGATOR
References: