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

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). 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).

Eligibility

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).

Conditions4

Locations1 site

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