Time Restricted Eating for the Treatment of Type 2 Diabetes

Obesity Clinical Trial

Official title:

Time Restricted Eating for the Treatment of Type 2 Diabetes

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05225337
• Other study ID #: 2021-1086
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 10, 2022
• Est. completion date: July 1, 2024

Study information

• Verified date: May 2024
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 75
• Est. completion date: July 1, 2024
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Obesity

Intervention

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)
• Daily calorie restriction
25% energy restriction every day Diet counseling provided

Locations

Country	Name	City	State
United States	University of Illinois Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Illinois at Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in percent body weight	Measured by an electronic scale	Measured at baseline and month 6
Secondary	Change in HbA1c	Measured by outside lab (Medstar, IN)	Measured at baseline and month 6
Secondary	Change in total time in euglycemic range	Measured by continuous glucose monitor (CGM)	Measured at baseline and month 6
Secondary	Change in mean glucose level	Measured by continuous glucose monitor (CGM)	Measured at baseline and month 6
Secondary	Change in standard deviation of glucose level	Measured by continuous glucose monitor (CGM)	Measured at baseline and month 6
Secondary	Change fasting glucose	Measured by outside lab (Medstar, IN)	Measured at baseline and month 6
Secondary	Change fasting insulin	Measured by outside lab (Medstar, IN)	Measured at baseline and month 6
Secondary	Change in Insulin sensitivity	Measured as QUICKI	Measured at baseline and month 6
Secondary	Change in insulin resistance	Measured as HOMA-IR	Measured at baseline and month 6
Secondary	Change in absolute body weight	Measured by electronic scale	Measured at baseline and month 6
Secondary	Change in fat mass, lean mass, visceral fat mass	Measured by DXA	Measured at baseline and month 6
Secondary	Change in waist circumference	Measured by measuring tape	Measured at baseline and month 6
Secondary	Change in body mass index (BMI)	Calculated as kg/meter squared	Measured at baseline and month 6
Secondary	Change in plasma lipids (total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides)	Measured by outside lab (Medstar, IN)	Measured at baseline and month 6
Secondary	Change in systolic and diastolic blood pressure	Measured by blood pressure cuff	Measured at baseline and month 6
Secondary	Change in heart rate	Measured by blood pressure cuff	Measured at baseline and month 6
Secondary	Change in energy and nutrient intake	Measured by 7-day food record	Measured at baseline and month 6
Secondary	Change in dietary adherence	Measured by 7-day food record and adherence log	Measured at baseline, month 3, and month 6
Secondary	Change in physical activity (steps/d)	Measured by pedometer	Measured at baseline and month 6
Secondary	Adverse events	Measured by adverse events survey	Measured weekly from baseline to month 6
Secondary	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
Secondary	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
Secondary	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
Secondary	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