Clinical trial NCT05365529: Time-Restricted Eating for Type II Diabetes: TRE-T2D
Official title: Feasibility and Efficacy of Time-Restricted Eating in Diabetes Management
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Time Restricted Feeding
Diabetes Type2
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: Salk Institute for Biological Studies
First posted: 2022-05-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

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.

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).

Primary outcomes:
measure: Glycemic regulation assessed by HbA1c
timeFrame: Baseline and 3 months
Secondary outcomes:
measure: Glycemic regulation assessed by Continuous Glucose Monitor (CGM)
timeFrame: Baseline and 3 months
measure: Fasting plasma glucose (mg/dL)
timeFrame: Baseline and 3 months
measure: Fasting plasma insulin (mIU/L)
timeFrame: Baseline and 3 months
measure: HOMA-IR
timeFrame: Baseline and 3 months
measure: LDL Particle Number (nmol/L)
timeFrame: Baseline and 3 months
measure: Non-HDL Cholesterol (mg/dL)
timeFrame: Baseline and 3 months
measure: Triglycerides (mg/dL)
timeFrame: Baseline and 3 months
measure: Apolipoprotein B (ApoB)
timeFrame: Baseline and 3 months
measure: Quality of life Assessment via Short Form-36 Questionnaire (SF-36)
timeFrame: Baseline and 3 months
Other outcomes:
measure: Safety of 8-10 hour TRE in patients with type II diabetes mellitus on stable medication assessed by daily fasting glucose and ketone measurements (finger pricks).
timeFrame: Baseline through 3 months
measure: Long term TRE adherence
timeFrame: 3-month to 6-month follow-up
Locations:
city: La Jolla
country: United States
facility: Altman Clinical and Translational Research Institute
state: California
Study officials:
affiliation: Professor of Medicine
name: Pam Taub, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.