Diabetes Mellitus, Type 2TRE-T2DNCT05365529
Time-Restricted Eating for Type II Diabetes: TRE-T2D
A study testing Time-Restricted Eating in people with Diabetes Mellitus, Type 2 and Time Restricted Feeding, run by University of California, San Diego at 1 site in United States.
Trial summary
This is a randomized clinical trial to assess the feasibility and efficacy of time-restricted eating (TRE) to improve glucose regulation and cardiovascular health of participants with type 2 diabetes mellitus (T2DM). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Time Restricted Feeding, Diabetes type2
- What is being tested?
- Time-Restricted Eating
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 16 May 2022to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18-75 years old
- Patients with T2DM with A1c between 6.5 and 9.0 % and on stable doses of medications who are weight-bearing and self-ambulatory.
- Own a smartphone (Apple iOS or Android OS)
- Baseline eating period ≥12 hours/day and sufficient logging on the mCC app.
- Women of childbearing age will be given a pregnancy test on study enrollment and asked to use contraception throughout the study.
- Post-menopausal and women on hormone replacement therapy will be included.
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- Estimated Glomerular Filtration Rate (EGFR) > 30mL/min/1.73m2
- If participants are on cardiovascular medications (HMG CoA reductase inhibitors (statins), other lipid-modifying drugs, anti-hypertensives) no dose adjustments will be allowed during the study period
- Patients on stable doses of GLP-1 receptor agonists will be included.
Who cannot join
- Participants with Type1DM and T2DM who are taking insulin, sulfonylureas, or have an HbA1c > 9 %.
- BMI > 50 kg/m2
- Systolic BP greater than 160 mmHg and/or Diastolic BP greater than 110 mmHg (with or without treatment/medication)
- LDL cholesterol greater than 200 mg/dL
- Triglycerides greater than 500 mg/dL
- Active tobacco or illicit drug use
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- Pregnant or breastfeeding women.
- Currently enrolled in a weight-loss or weight-management program,
- Currently on a special or prescribed diet for other reasons (e.g., Celiac disease),
- The recent initiation, within the 3 preceding months prior to study enrollment, of medications designed for weight loss or with recognized appetite-suppressant effects (e.g. GLP-1 receptor agonists). Patients that are stable on such medications for at least 3 months can still be enrolled.
- History of eating disorder(s).
- History of surgical intervention for weight management (e) active eating disorder.
- Chronic kidney disease with an eGFR calculated based on the Modification of Diet in Renal Disease (MDRD) equation < 30mL/min/1.73m2
- Treatment for active inflammatory and/or rheumatologic disease and cancer.
- A major adverse cardiovascular event within the past 6 months such as acute coronary syndrome (ACS), percutaneous coronary intervention, coronary artery bypass graft surgery, hospitalization for congestive heart failure, stroke/transient ischemic attack (TIA).
- History of Uncontrolled arrhythmia (i.e., rate-controlled atrial fibrillation/atrial flutter are not exclusion criteria)
- Liver cirrhosis and/or significant alterations in liver function
- History of (a) thyroid disease requiring dose titration of thyroid replacement medication(s) within the past 3 months (i.e., hypothyroidism on a stable dose of thyroid replacement therapy is not an exclusion),
- Known inflammatory and/or rheumatologic disease.
- Shift workers with variable (e.g., nocturnal) hours.
- Caregivers for dependents requiring frequent nocturnal care/sleep interruptions.
- More than one trip planned to travel to a time zone with greater than a 3-hour difference during study period.
- History of major adverse cardiovascular events within the past 1 year (acute coronary syndrome (ACS), percutaneous coronary intervention, coronary artery bypass graft surgery, hospitalization for congestive heart failure, stroke/transient ischemic attack (TIA)).
- History of thyroid disease requiring dose titration of thyroid replacement medication(s) within the past 3 months (i.e., hypothyroidism on a stable dose of thyroid replacement therapy is not an exclusion).
- History of adrenal disease.
- History of malignancy undergoing active treatment, except non-melanoma skin cancer.
- Known history of type I diabetes.
- History of stage 4 or 5 chronic kidney disease or requiring dialysis.
- History of HIV/AIDS.
- Uncontrolled psychiatric disorder (including history of hospitalization for psychiatric illness).
Trial locations and contacts
1 site in 1 country.
United States1 site
Altman Clinical and Translational Research Institute
La Jolla, California, 92093
About this study
Official title: Feasibility and Efficacy of Time-Restricted Eating in Diabetes Management
This is a randomized clinical trial to assess the feasibility and efficacy of time-restricted eating (TRE) to improve glucose regulation and cardiovascular health of participants with type 2 diabetes mellitus (T2DM). Participants will be randomized into 2 groups: 1) standard of care (SOC), in which they will continue to follow their physician's treatment plan, or 2) SOC and TRE (8-10 hours eating window).
Read the detailed description
The intervention will last for 12 weeks with a follow-up assessment at 6 months. This study will deliver the intervention, monitor participant health for safety, and promote compliance through clinic visits, virtual consultations, and an innovative combination of sensors, including continuous glucose monitors, actiwatches (to assess activity and sleep patterns), and the myCircadianClock smartphone app (to capture food, beverage, and medicine intake in real time). In-depth clinical and analytical measurements will be conducted at baseline and at the end of the intervention. We hypothesize that TRE will result in improved glucose levels (assessed via Hemoglobin A1c, the gold standard in clinical trials of T2D) and improved cardiovascular health (assessed via LDL or "bad" Cholesterol and Triglycerides). We will also be examining long-term adherence to TRE and improvements in quality of life. The proposed study will be the first adequately powered, randomized trial of TRE in patients with T2DM on background medical therapy. It is founded on a strong scientific premise and utilizes rigorous study design, state-of-the-art methods for analyzing outcomes, and an innovative approach for engaging and sustaining participation. Successful completion of this clinical trial will lay the scientific foundation and establish safety parameters for widespread implementation of TRE in patients with T2DM.
- Being tested
- Time-Restricted Eating, Standard of Care
- Medical subject headings
- Diabetes Mellitus, Type 2, Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time-Restricted EatingBehavioural
Also called Time Restricted Feeding
Participants in the TRE group with continue to follow their physicians treatment plan for type II diabetes mellitus and consume all of their food within an 8-10 hour eating window.
Standard of CareBehavioural
Also called Control group
Participants in the Standard of Care group will continue to follow their physician's treatment plan for type II diabetes mellitus.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Placebo comparator | The participants in this arm will receive the standard health and nutritional wellness guidelines and will be required to log food entries through the use of a smartphone app. Receives: Behavioral: Standard of Care |
| Time-Restricted Eating | Experimental | The participants in this arm will limit the number of hours they eat in day to a 8-10-hour window and will also receive the standard health and nutritional wellness guidelines. They will also be required to log food entries through the use of a smartphone app. Receives: Behavioral: Time-Restricted Eating |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic regulation assessed by HbA1c
Change in blood glucose assessed via hemoglobin A1c.
Measured: Baseline and 3 months
Secondary outcomes (9)
Glycemic regulation assessed by Continuous Glucose Monitor (CGM)
Change in glycemic regulation as assessed by CGM from interstitial glucose with outcomes including time in range, glycemic variability, and mean glucose.
Measured: Baseline and 3 months
Fasting plasma glucose (mg/dL)
Change in glycemic regulation as assessed fasting plasma glucose (mg/dL).
Measured: Baseline and 3 months
Fasting plasma insulin (mIU/L)
Change in glycemic regulation as assessed changes in fasting plasma insulin (mIU/L).
Measured: Baseline and 3 months
HOMA-IR
Change in glycemic regulation as assessed by HOMA-IR.
Measured: Baseline and 3 months
LDL Particle Number (nmol/L)
Changes in atherogenic lipids assessed via LDL Particle Number (nmol/L) via NMR Lipoproteinprofile.
Measured: Baseline and 3 months
Non-HDL Cholesterol (mg/dL)
Changes in atherogenic lipids assessed via Non-HDL Cholesterol (mg/dL).
Measured: Baseline and 3 months
Triglycerides (mg/dL)
Changes in atherogenic lipids assessed via Triglycerides (mg/dL).
Measured: Baseline and 3 months
Apolipoprotein B (ApoB)
Changes in atherogenic lipids assessed via ApoB (mg/dL).
Measured: Baseline and 3 months
Quality of life Assessment via Short Form-36 Questionnaire (SF-36)
Changes in quality of life as assessed by the SF-36 questionnaire.
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2022
- Study start16 May 2022
- Primary completion22 Dec 2025
- Study completion31 Dec 2026 (estimated)
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.
- 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- Salk Institute for Biological Studies
- Responsible party
- Principal investigator, Pam Taub, MD, University of California, San Diego
- Investigators
- Pam Taub, MD, Principal investigator, Professor of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05365529
- Sponsor's protocol ID
- 801955
- Acronym
- TRE-T2D
- Status last verified
- Jun 2026
- First submitted
- 10 Mar 2022
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Taub PR, Panda S. Time for better time-restricted eating trials to lessen the burden of metabolic diseases. Cell Rep Med. 2022 Jun 21;3(6):100665. doi: 10.1016/j.xcrm.2022.100665.
PubMed 35732151
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Efficacy of Time-Restricted Eating in Diabetes Management
- ClinicalTrials.gov ID
- NCT05365529
- Acronym / sponsor ID
- TRE-T2D / 801955
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- Salk Institute for Biological Studies
- Study start
- 16 May 2022 (actual)
- Primary completion
- 22 Dec 2025 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 9 May 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.
This is a randomized clinical trial to assess the feasibility and efficacy of time-restricted eating (TRE) to improve glucose regulation and cardiovascular health of participants with type 2 diabetes mellitus (T2DM). Participants will be randomized into 2 groups: 1) standard of care (SOC), in which they will continue to follow their physician's treatment plan, or 2) SOC and TRE (8-10 hours eating window).
Detailed description
The intervention will last for 12 weeks with a follow-up assessment at 6 months. This study will deliver the intervention, monitor participant health for safety, and promote compliance through clinic visits, virtual consultations, and an innovative combination of sensors, including continuous glucose monitors, actiwatches (to assess activity and sleep patterns), and the myCircadianClock smartphone app (to capture food, beverage, and medicine intake in real time). In-depth clinical and analytical measurements will be conducted at baseline and at the end of the intervention. We hypothesize that TRE will result in improved glucose levels (assessed via Hemoglobin A1c, the gold standard in clinical trials of T2D) and improved cardiovascular health (assessed via LDL or "bad" Cholesterol and Triglycerides). We will also be examining long-term adherence to TRE and improvements in quality of life. The proposed study will be the first adequately powered, randomized trial of TRE in patients with T2DM on background medical therapy. It is founded on a strong scientific premise and utilizes rigorous study design, state-of-the-art methods for analyzing outcomes, and an innovative approach for engaging and sustaining participation. Successful completion of this clinical trial will lay the scientific foundation and establish safety parameters for widespread implementation of TRE in patients with T2DM.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Placebo comparator | Behavioral: Standard of CareThe participants in this arm will receive the standard health and nutritional wellness guidelines and will be required to log food entries through the use of a smartphone app. |
| Time-Restricted Eating | Experimental | Behavioral: Time-Restricted EatingThe participants in this arm will limit the number of hours they eat in day to a 8-10-hour window and will also receive the standard health and nutritional wellness guidelines. They will also be required to log food entries through the use of a smartphone app. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age: 18-75 years old
- Patients with T2DM with A1c between 6.5 and 9.0 % and on stable doses of medications who are weight-bearing and self-ambulatory.
- Own a smartphone (Apple iOS or Android OS)
- Baseline eating period ≥12 hours/day and sufficient logging on the mCC app.
- Women of childbearing age will be given a pregnancy test on study enrollment and asked to use contraception throughout the study.
Key exclusion criteria (30 listed)
- Participants with Type1DM and T2DM who are taking insulin, sulfonylureas, or have an HbA1c > 9 %.
- BMI > 50 kg/m2
- Systolic BP greater than 160 mmHg and/or Diastolic BP greater than 110 mmHg (with or without treatment/medication)
- LDL cholesterol greater than 200 mg/dL
- Triglycerides greater than 500 mg/dL
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 EatingAlso: Time Restricted FeedingParticipants in the TRE group with continue to follow their physicians treatment plan for type II diabetes mellitus and consume all of their food within an 8-10 hour eating window. | Behavioural | Time-Restricted Eating |
| Standard of CareAlso: Control groupParticipants in the Standard of Care group will continue to follow their physician's treatment plan for type II diabetes mellitus. | Behavioural | Standard of Care |
Primary outcome
Glycemic regulation assessed by HbA1c
Time frame: Baseline and 3 months
Change in blood glucose assessed via hemoglobin A1c.
9 secondary outcomes
Glycemic regulation assessed by Continuous Glucose Monitor (CGM)
Time frame: Baseline and 3 months
Fasting plasma glucose (mg/dL)
Time frame: Baseline and 3 months
Fasting plasma insulin (mIU/L)
Time frame: Baseline and 3 months
HOMA-IR
Time frame: Baseline and 3 months
LDL Particle Number (nmol/L)
Time frame: Baseline and 3 months
Non-HDL Cholesterol (mg/dL)
Time frame: Baseline and 3 months
Triglycerides (mg/dL)
Time frame: Baseline and 3 months
Apolipoprotein B (ApoB)
Time frame: Baseline and 3 months
Quality of life Assessment via Short Form-36 Questionnaire (SF-36)
Time frame: Baseline and 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Derived from this study: PubMed 35732151Taub PR, Panda S. Time for better time-restricted eating trials to lessen the burden of metabolic diseases. Cell Rep Med. 2022 Jun 21;3(6):100665. doi: 10.1016/j.xcrm.2022.100665.
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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.
Pam Taub, MD principal investigator
Professor of Medicine
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 Eating in people with Diabetes Mellitus, Type 2 and Time Restricted Feeding, run by University of California, San Diego 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 9 inclusion and 30 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: under way, not looking for participants, as of the sponsor's last update on 11 Jun 2026. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
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?
Glycemic regulation assessed by HbA1c (time frame: Baseline and 3 months). 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 NCT05365529, 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 11 Jun 2026.