Time Restricted Eating for the Treatment of Type 2 Diabetes
1 other identifier
interventional
75
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable diabetes-mellitus-type-2
Started Feb 2022
Typical duration for not_applicable diabetes-mellitus-type-2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 25, 2022
CompletedFirst Posted
Study publicly available on registry
February 4, 2022
CompletedStudy Start
First participant enrolled
February 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 25, 2024
CompletedNovember 27, 2024
November 1, 2024
1.1 years
January 25, 2022
November 25, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Change in percent body weight
Measured by an electronic scale
Measured at baseline and month 6
Secondary Outcomes (23)
Change in HbA1c
Measured at baseline and month 6
Change in total time in euglycemic range
Measured at baseline and month 6
Change in mean glucose level
Measured at baseline and month 6
Change in standard deviation of glucose level
Measured at baseline and month 6
Change fasting glucose
Measured at baseline and month 6
- +18 more secondary outcomes
Study Arms (3)
Time restricted feeding (TRF)
EXPERIMENTAL8-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 (CR)
EXPERIMENTAL25% energy restriction every day Diet counseling provided
Control
NO INTERVENTIONAd libitum food intake, eating over more than 10 hours per day
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Illinois Chicago
Chicago, Illinois, 60612, United States
Related Publications (1)
Pavlou V, Cienfuegos S, Lin S, Ezpeleta M, Ready K, Corapi S, Wu J, Lopez J, Gabel K, Tussing-Humphreys L, Oddo VM, Alexandria SJ, Sanchez J, Unterman T, Chow LS, Vidmar AP, Varady KA. Effect of Time-Restricted Eating on Weight Loss in Adults With Type 2 Diabetes: A Randomized Clinical Trial. JAMA Netw Open. 2023 Oct 2;6(10):e2339337. doi: 10.1001/jamanetworkopen.2023.39337.
PMID: 37889487DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Krista Varady
University of Illinois Chicago
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Nutrition
Study Record Dates
First Submitted
January 25, 2022
First Posted
February 4, 2022
Study Start
February 10, 2022
Primary Completion
April 1, 2023
Study Completion
November 25, 2024
Last Updated
November 27, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will not share