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Time Restricted Eating for the Treatment of Type 2 Diabetes

Primary Purpose

Diabetes Mellitus, Type 2, Obesity

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Time restricted feeding (TRF)
Daily calorie restriction
Sponsored by
University of Illinois at Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • BMI between 27 and 50 kg/m2
  • T2DM (HbA1c: >6.5%)
  • Sedentary or lightly active

Exclusion Criteria:

  • Normoglycemic (HbA1c <5.7%) or have prediabetes: HbA1c: 5.7-6.4%
  • 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 kg)
  • Not able to keep a food diary for 7 consecutive days during screening
  • Taking certain drugs that effect outcomes (weight loss medications)
  • Perimenopausal (menses does not appear every 27-32d)
  • Pregnant, or trying to become pregnant
  • Night shift workers
  • Smokers

Sites / Locations

  • University of Illinois Chicago

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Time restricted feeding (TRF)

Daily calorie restriction (CR)

Control

Arm 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)

25% energy restriction every day Diet counseling provided

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

Outcomes

Primary Outcome Measures

Change in percent body weight
Measured by an electronic scale

Secondary Outcome Measures

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

Full Information

First Posted
January 25, 2022
Last Updated
May 31, 2023
Sponsor
University of Illinois at Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT05225337
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 10, 2022 (Actual)
Primary Completion Date
April 1, 2023 (Actual)
Study Completion Date
July 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Chicago

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Time restricted feeding (TRF)
Arm Type
Experimental
Arm 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)
Arm Title
Daily calorie restriction (CR)
Arm Type
Experimental
Arm Description
25% energy restriction every day Diet counseling provided
Arm Title
Control
Arm Type
No Intervention
Arm Description
Ad libitum food intake, eating over more than 10 hours per day
Intervention Type
Other
Intervention Name(s)
Time restricted feeding (TRF)
Intervention 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)
Intervention Type
Other
Intervention Name(s)
Daily calorie restriction
Intervention Description
25% energy restriction every day Diet counseling provided
Primary Outcome Measure Information:
Title
Change in percent body weight
Description
Measured by an electronic scale
Time Frame
Measured at baseline and month 6
Secondary Outcome Measure Information:
Title
Change in HbA1c
Description
Measured by outside lab (Medstar, IN)
Time Frame
Measured at baseline and month 6
Title
Change in total time in euglycemic range
Description
Measured by continuous glucose monitor (CGM)
Time Frame
Measured at baseline and month 6
Title
Change in mean glucose level
Description
Measured by continuous glucose monitor (CGM)
Time Frame
Measured at baseline and month 6
Title
Change in standard deviation of glucose level
Description
Measured by continuous glucose monitor (CGM)
Time Frame
Measured at baseline and month 6
Title
Change fasting glucose
Description
Measured by outside lab (Medstar, IN)
Time Frame
Measured at baseline and month 6
Title
Change fasting insulin
Description
Measured by outside lab (Medstar, IN)
Time Frame
Measured at baseline and month 6
Title
Change in Insulin sensitivity
Description
Measured as QUICKI
Time Frame
Measured at baseline and month 6
Title
Change in insulin resistance
Description
Measured as HOMA-IR
Time Frame
Measured at baseline and month 6
Title
Change in absolute body weight
Description
Measured by electronic scale
Time Frame
Measured at baseline and month 6
Title
Change in fat mass, lean mass, visceral fat mass
Description
Measured by DXA
Time Frame
Measured at baseline and month 6
Title
Change in waist circumference
Description
Measured by measuring tape
Time Frame
Measured at baseline and month 6
Title
Change in body mass index (BMI)
Description
Calculated as kg/meter squared
Time Frame
Measured at baseline and month 6
Title
Change in plasma lipids (total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides)
Description
Measured by outside lab (Medstar, IN)
Time Frame
Measured at baseline and month 6
Title
Change in systolic and diastolic blood pressure
Description
Measured by blood pressure cuff
Time Frame
Measured at baseline and month 6
Title
Change in heart rate
Description
Measured by blood pressure cuff
Time Frame
Measured at baseline and month 6
Title
Change in energy and nutrient intake
Description
Measured by 7-day food record
Time Frame
Measured at baseline and month 6
Title
Change in dietary adherence
Description
Measured by 7-day food record and adherence log
Time Frame
Measured at baseline, month 3, and month 6
Title
Change in physical activity (steps/d)
Description
Measured by pedometer
Time Frame
Measured at baseline and month 6
Title
Adverse events
Description
Measured by adverse events survey
Time Frame
Measured weekly from baseline to month 6
Title
Change in medication effect score (MES)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Krista Varady
Organizational Affiliation
University of Illinois Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Illinois Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Time Restricted Eating for the Treatment of Type 2 Diabetes

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