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Time-Restricted eating: a new weapon against diabetes?

NCT ID NCT05365529

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether time-restricted eating (eating all meals within an 8-10 hour window each day) can help people with type 2 diabetes better control their blood sugar and improve heart health. About 60 adults with type 2 diabetes will either follow their usual care or add time-restricted eating for several months. Researchers will measure changes in blood sugar levels and other health markers to see if this eating pattern is both feasible and effective.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Time-restricted eating (eating all food within an 8-10 hour window each day)
What this could lead to
If it works, this could offer a simple, drug-free way to help manage blood sugar and improve heart health for people with type 2 diabetes.
What could go wrong
This is a small, early feasibility study with only 60 participants. The results may not apply to everyone, and sticking to a strict eating window can be challenging for some people.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2022

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria 1. Age: 18-75 years old 2. Patients with T2DM with A1c between 6.5 and 9.0 % and on stable doses of medications who are weight-bearing and self-ambulatory. 3. Own a smartphone (Apple iOS or Android OS) 4. Baseline eating period ≥12 hours/day and sufficient logging on the mCC app. 5. Women of childbearing age will be given a pregnancy test on study enrollment and asked to use contraception throughout the study. 6. Post-menopausal and women on hormone replacement therapy will be included. 7. Estimated Glomerular Filtration Rate (EGFR) \> 30mL/min/1.73m2 8. 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 9. Patients on stable doses of GLP-1 receptor agonists will be included. Exclusion Criteria 10. Participants with Type1DM and T2DM who are taking insulin, sulfonylureas, or have an HbA1c \> 9 %. 11. BMI \> 50 kg/m2 12. Systolic BP greater than 160 mmHg and/or Diastolic BP greater than 110 mmHg (with or without treatment/medication) 13. LDL cholesterol greater than 200 mg/dL 14. Triglycerides greater than 500 mg/dL 15. Active tobacco or illicit drug use 16. Pregnant or breastfeeding women. 17. Currently enrolled in a weight-loss or weight-management program, 18. Currently on a special or prescribed diet for other reasons (e.g., Celiac disease), 19. 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. 20. History of eating disorder(s). 21. History of surgical intervention for weight management (e) active eating disorder. 22. Chronic kidney disease with an eGFR calculated based on the Modification of Diet in Renal Disease (MDRD) equation \< 30mL/min/1.73m2 23. Treatment for active inflammatory and/or rheumatologic disease and cancer. 24. 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). 25. History of Uncontrolled arrhythmia (i.e., rate-controlled atrial fibrillation/atrial flutter are not exclusion criteria) 26. Liver cirrhosis and/or significant alterations in liver function 27. 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), 28. Known inflammatory and/or rheumatologic disease. 29. Shift workers with variable (e.g., nocturnal) hours. 30. Caregivers for dependents requiring frequent nocturnal care/sleep interruptions. 31. More than one trip planned to travel to a time zone with greater than a 3-hour difference during study period. 32. 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)). 33. 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). 34. History of adrenal disease. 35. History of malignancy undergoing active treatment, except non-melanoma skin cancer. 36. Known history of type I diabetes. 37. History of stage 4 or 5 chronic kidney disease or requiring dialysis. 38. History of HIV/AIDS. 39. Uncontrolled psychiatric disorder (including history of hospitalization for psychiatric illness).

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Conditions

The condition(s) this trial relates to.

Intermittent Fasting type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Altman Clinical and Translational Research Institute

    La Jolla, California, 92093, United States

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Other studies related to the condition(s) this trial covers.