Time Restricted Eating for the Treatment of Type 2 Diabetes

University of Illinois

Status: Completed

Conditions: Obesity; Diabetes Mellitus, Type 2

Treatments: Other: Daily calorie restriction; Other: Time restricted feeding (TRF)

Study type: Interventional

Funder types: Other

Identifiers

NCT05225337

2021-1086

Details and patient eligibility

About

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.

Enrollment: 75 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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75 participants in 3 patient groups

Time restricted feeding (TRF)

Experimental group

Description:

8-h eating window Ad libitum food intake from 12-8 pm every day Fasting from 8-12 pm every day (16-h fast)

Treatment:

Other: Time restricted feeding (TRF)

Daily calorie restriction (CR)

Experimental group

Description:

25% energy restriction every day Diet counseling provided

Treatment:

Other: Daily calorie restriction

Control

No Intervention group

Description:

Ad libitum food intake, eating over more than 10 hours per day