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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
Participants in the TRE group with continue to follow their physicians treatment plan for type II diabetes mellitus and consume all of their food within an 8-10 hour eating window.
Participants in the Standard of Care group will continue to follow their physician's treatment plan for type II diabetes mellitus.
Altman Clinical and Translational Research Institute
La Jolla, California, United States
Glycemic regulation assessed by HbA1c
Change in blood glucose assessed via hemoglobin A1c.
Time frame: Baseline and 3 months
Glycemic regulation assessed by Continuous Glucose Monitor (CGM)
Change in glycemic regulation as assessed by CGM from interstitial glucose with outcomes including time in range, glycemic variability, and mean glucose.
Time frame: Baseline and 3 months
Fasting plasma glucose (mg/dL)
Change in glycemic regulation as assessed fasting plasma glucose (mg/dL).
Time frame: Baseline and 3 months
Fasting plasma insulin (mIU/L)
Change in glycemic regulation as assessed changes in fasting plasma insulin (mIU/L).
Time frame: Baseline and 3 months
HOMA-IR
Change in glycemic regulation as assessed by HOMA-IR.
Time frame: Baseline and 3 months
LDL Particle Number (nmol/L)
Changes in atherogenic lipids assessed via LDL Particle Number (nmol/L) via NMR Lipoproteinprofile.
Time frame: Baseline and 3 months
Non-HDL Cholesterol (mg/dL)
Changes in atherogenic lipids assessed via Non-HDL Cholesterol (mg/dL).
Time frame: Baseline and 3 months
Triglycerides (mg/dL)
Changes in atherogenic lipids assessed via Triglycerides (mg/dL).
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Time frame: Baseline and 3 months
Apolipoprotein B (ApoB)
Changes in atherogenic lipids assessed via ApoB (mg/dL).
Time frame: Baseline and 3 months
Quality of life Assessment via Short Form-36 Questionnaire (SF-36)
Changes in quality of life as assessed by the SF-36 questionnaire.
Time frame: Baseline and 3 months