Time-Restricted Eating for Type II Diabetes: TRE-T2D

Launched by UNIVERSITY OF CALIFORNIA, SAN DIEGO · May 3, 2022

Keywords

ClinConnect Summary

The TRE-T2D clinical trial is exploring how time-restricted eating (TRE) can help improve blood sugar control and heart health in adults with type 2 diabetes. In this study, participants will be divided into two groups: one will continue with their usual diabetes treatment, while the other will follow the same treatment but with a specific eating schedule, where they only eat during an 8 to 10-hour window each day. This trial is currently looking for volunteers aged 18 to 75 who have type 2 diabetes and meet certain health criteria, such as having stable blood sugar levels and owning a smartphone.

Participants in the trial can expect to maintain their regular diabetes medications, and they will be supported with tools to track their eating habits. It's important to note that people with certain conditions, like those using insulin or having very high blood pressure or cholesterol levels, may not be eligible for this study. Overall, this trial aims to see if changing the timing of meals can be a helpful strategy for managing diabetes.

Gender

ALL

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).