Diabetes Mellitus, Type 2NCT05225337
Time Restricted Eating for the Treatment of Type 2 Diabetes
A study testing Time restricted feeding (TRF) and Daily calorie restriction in people with Diabetes Mellitus, Type 2 and Obesity, run by University of Illinois Chicago at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Obesity
- What is being tested?
- Time restricted feeding (TRF) and Daily calorie restriction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Feb 2022to 25 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 9Show fewer
- Pregnant, or trying to become pregnant
- Night shift workers
- Smokers
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois Chicago
Chicago, Illinois, 60612
About this study
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.
- Conditions
- Diabetes Mellitus, Type 2, Obesity
- Being tested
- Time restricted feeding (TRF), Daily calorie restriction
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time restricted feeding (TRF)Other
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 restrictionOther
25% energy restriction every day Diet counseling provided
| Study group | Role | What they receive |
|---|---|---|
| Time restricted feeding (TRF) | Experimental | 8-h eating window Ad libitum food intake from 12-8 pm every day Fasting from 8-12 pm every day (16-h fast) Receives: Other: Time restricted feeding (TRF) |
| Daily calorie restriction (CR) | Experimental | 25% energy restriction every day Diet counseling provided Receives: Other: Daily calorie restriction |
| Control | No intervention | Ad libitum food intake, eating over more than 10 hours per day |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in percent body weight
Measured by an electronic scale
Measured: Measured at baseline and month 6
Secondary outcomes (23)
Change in HbA1c
Measured by outside lab (Medstar, IN)
Measured: Measured at baseline and month 6
Change in total time in euglycemic range
Measured by continuous glucose monitor (CGM)
Measured: Measured at baseline and month 6
Change in mean glucose level
Measured by continuous glucose monitor (CGM)
Measured: Measured at baseline and month 6
Change in standard deviation of glucose level
Measured by continuous glucose monitor (CGM)
Measured: Measured at baseline and month 6
Change fasting glucose
Measured by outside lab (Medstar, IN)
Measured: Measured at baseline and month 6
Change fasting insulin
Measured by outside lab (Medstar, IN)
Measured: Measured at baseline and month 6
Change in Insulin sensitivity
Measured as QUICKI
Measured: Measured at baseline and month 6
Change in insulin resistance
Measured as HOMA-IR
Measured: Measured at baseline and month 6
Change in absolute body weight
Measured by electronic scale
Measured: Measured at baseline and month 6
Change in fat mass, lean mass, visceral fat mass
Measured by DXA
Measured: Measured at baseline and month 6
Change in waist circumference
Measured by measuring tape
Measured: Measured at baseline and month 6
Change in body mass index (BMI)
Calculated as kg/meter squared
Measured: Measured at baseline and month 6
Change in plasma lipids (total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides)
Measured by outside lab (Medstar, IN)
Measured: Measured at baseline and month 6
Change in systolic and diastolic blood pressure
Measured by blood pressure cuff
Measured: Measured at baseline and month 6
Change in heart rate
Measured by blood pressure cuff
Measured: Measured at baseline and month 6
Change in energy and nutrient intake
Measured by 7-day food record
Measured: Measured at baseline and month 6
Change in dietary adherence
Measured by 7-day food record and adherence log
Measured: Measured at baseline, month 3, and month 6
Change in physical activity (steps/d)
Measured by pedometer
Measured: Measured at baseline and month 6
Adverse events
Measured by adverse events survey
Measured: 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: 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: 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: 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: Measured at baseline and month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2022
- Study start10 Feb 2022
- Primary completion1 Apr 2023
- Study completion25 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Krista Varady, University of Illinois Chicago
- Investigators
- Krista Varady, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05225337
- Sponsor's protocol ID
- 2021-1086
- Status last verified
- Nov 2024
- First submitted
- 25 Jan 2022
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37889487
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time Restricted Eating for the Treatment of Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT05225337
- Acronym / sponsor ID
- 2021-1086
- Conditions
- Diabetes Mellitus, Type 2, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Study start
- 10 Feb 2022 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 25 Nov 2024 (actual)
- First posted
- 4 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Time restricted feeding (TRF) | Experimental | 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 (CR) | Experimental | Other: Daily calorie restriction25% energy restriction every day Diet counseling provided |
| Control | No intervention | –Ad libitum food intake, eating over more than 10 hours per day |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) |
| Daily calorie restriction25% energy restriction every day Diet counseling provided | Other | Daily calorie restriction (CR) |
Primary outcome
Change in percent body weight
Time frame: Measured at baseline and month 6
Measured by an electronic scale
23 secondary outcomes
Change in HbA1c
Time frame: Measured at baseline and month 6
Change in total time in euglycemic range
Time frame: Measured at baseline and month 6
Change in mean glucose level
Time frame: Measured at baseline and month 6
Change in standard deviation of glucose level
Time frame: Measured at baseline and month 6
Change fasting glucose
Time frame: Measured at baseline and month 6
Change fasting insulin
Time frame: Measured at baseline and month 6
Change in Insulin sensitivity
Time frame: Measured at baseline and month 6
Change in insulin resistance
Time frame: Measured at baseline and month 6
Change in absolute body weight
Time frame: Measured at baseline and month 6
Change in fat mass, lean mass, visceral fat mass
Time frame: Measured at baseline and month 6
Change in waist circumference
Time frame: Measured at baseline and month 6
Change in body mass index (BMI)
Time frame: Measured at baseline and month 6
Change in plasma lipids (total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides)
Time frame: Measured at baseline and month 6
Change in systolic and diastolic blood pressure
Time frame: Measured at baseline and month 6
Change in heart rate
Time frame: Measured at baseline and month 6
Change in energy and nutrient intake
Time frame: Measured at baseline and month 6
Change in dietary adherence
Time frame: Measured at baseline, month 3, and month 6
Change in physical activity (steps/d)
Time frame: Measured at baseline and month 6
Adverse events
Time frame: Measured weekly from baseline to month 6
Change in medication effect score (MES)
Time frame: Measured at baseline and month 6
Change in sleep quality
Time frame: Measured at baseline and month 6
Change in insomnia severity
Time frame: Measured at baseline and month 6
Change in risk of sleep apnea
Time frame: Measured at baseline and month 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
- Derived from this study: PubMed 37889487Pavlou 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Krista Varady principal investigator
University of Illinois Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Time restricted feeding (TRF) and Daily calorie restriction in people with Diabetes Mellitus, Type 2 and Obesity, run by University of Illinois Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in percent body weight (time frame: Measured at baseline and month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05225337, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2024.