Time-restricted eating for improving diabetes management

Feasibility and Efficacy of Time-Restricted Eating in Diabetes Management

This study is testing if eating within a specific 8-10 hour window can help people with type 2 diabetes manage their blood sugar and heart health better than usual care alone.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: University of California, San Diego (Academic / other)
• Locations: 1 site (La Jolla, California)
• Trial ID: NCT05365529 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the feasibility and effectiveness of time-restricted eating (TRE) in enhancing glucose regulation and cardiovascular health in individuals with type 2 diabetes mellitus (T2DM). Participants will be randomly assigned to either a standard care group or a group that combines standard care with TRE, which involves an 8-10 hour eating window. The intervention lasts for 12 weeks, followed by a 6-month assessment, and utilizes advanced monitoring tools such as continuous glucose monitors and a smartphone app to track dietary intake and health metrics. The study aims to determine if TRE can lead to significant improvements in glucose levels and cardiovascular health, while also assessing long-term adherence and quality of life. This trial is notable for being the first adequately powered randomized trial of TRE in T2DM patients receiving medical therapy.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with type 2 diabetes and an A1c between 6.5 and 9.0%, who are on stable medication doses and can use a smartphone.

Not a fit: Patients with type 1 diabetes, those taking insulin or sulfonylureas, or individuals with a BMI over 50 kg/m2 may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a novel dietary strategy to improve glucose control and cardiovascular health in patients with type 2 diabetes.

How similar studies have performed: Other studies have shown promising results with time-restricted eating, but this trial is one of the first to rigorously assess its effects in a randomized format for T2DM patients.

Eligibility criteria

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).

Where this trial is running

La Jolla, California

• Altman Clinical and Translational Research Institute — La Jolla, California, United States (Recruiting)

Study contacts

• Principal investigator: Pam Taub, MD — Professor of Medicine
• Study coordinator: Justina P Nguyen, BS

Conditions Diabetes Mellitus, Type 2; Time Restricted Feeding; Diabetes Type2