Time Restricted Eating for the Treatment of Type 2 Diabetes

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 Overview

• Status: Completed
• Conditions: Obesity; Diabetes Mellitus, Type 2
• Intervention / Treatment: Other: Time restricted feeding (TRF); Other: Daily calorie restriction

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • University of Illinois Chicago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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
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.	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).	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	Measured at baseline and month 6

Collaborators and Investigators

• Sponsor: University of Illinois at Chicago
• Investigators: Principal Investigator: Krista Varady, University of Illinois Chicago

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2022
• Primary Completion (Actual): April 1, 2023
• Study Completion (Actual): November 25, 2024

Study Registration Dates

• First Submitted: January 25, 2022
• First Submitted That Met QC Criteria: January 25, 2022
• First Posted (Actual): February 4, 2022

Study Record Updates

• Last Update Posted (Estimated): November 27, 2024
• Last Update Submitted That Met QC Criteria: November 25, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus, Type 2; Diabetes Mellitus
• Other Study ID Numbers: 2021-1086

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No