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

Diabetes Mellitus, Type 2 Clinical Trial

— TRE-T2D  

Official title:

Feasibility and Efficacy of Time-Restricted Eating in Diabetes Management

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05365529
• Other study ID #: 801955
• Status: Recruiting
• Phase: N/A
• Start date: May 16, 2022
• Est. completion date: March 2026

Study information

• Verified date: August 2023
• Source: University of California, San Diego
• Contact: Justina P Nguyen, BS
• Phone: 858-246-2406
• Email: preventivecvresearch[@]health.ucsd.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Age: 18-70 years old
• Patients with T2DM with A1c between 6.5 and 9.0 % and on stable doses of medications who are weight-bearing and self-ambulatory.
• Own a smartphone (Apple iOS or Android OS)
• Baseline eating period =12 hours/day and sufficient logging on the mCC app.
• Women of childbearing age will be given a pregnancy test on study enrollment and asked to use contraception throughout the study.
• Post-menopausal and women on hormone replacement therapy will be included.
• Estimated Glomerular Filtration Rate (EGFR) > 50
• 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
• Patients on stable doses of GLP-1 receptor agonists will be included.

Exclusion Criteria:

• Participants with Type1DM and T2DM who are taking insulin, sulfonylureas, or have an HbA1c > 9 %.
• BMI > 40 kg/m2
• Systolic BP greater than 160 mmHg and/or Diastolic BP greater than 110 mmHg (with or without treatment/medication)
• LDL cholesterol greater than 200 mg/dL
• Triglycerides greater than 500 mg/dL
• Active tobacco or illicit drug use
• Pregnant or breastfeeding women.
• Currently enrolled in a weight-loss or weight-management program,
• Currently on a special or prescribed diet for other reasons (e.g., Celiac disease),
• Currently taking any medication that is meant for weight loss, or has known effect on appetite suppression,
• History of eating disorder(s).
• History of surgical intervention for weight management (e) active eating disorder.
• Chronic kidney disease with an eGFR calculated based on the Modification of Diet in Renal Disease (MDRD) equation <50mL/min/1.73m2
• Treatment for active inflammatory and/or rheumatologic disease and cancer.
• 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).
• History of Uncontrolled arrhythmia (i.e., rate-controlled atrial fibrillation/atrial flutter are not exclusion criteria)
• Liver cirrhosis and/or significant alterations in liver function
• 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)
• Known inflammatory and/or rheumatologic disease.
• Shift workers with variable (e.g., nocturnal) hours.
• Caregivers for dependents requiring frequent nocturnal care/sleep interruptions.
• More than one trip planned to travel to a time zone with greater than a 3-hour difference during study period.
• 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)).
• 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).
• History of adrenal disease.
• History of malignancy undergoing active treatment, except non-melanoma skin cancer.
• Known history of type I diabetes.
• History of stage 4 or 5 chronic kidney disease or requiring dialysis.
• History of HIV/AIDS.
• Uncontrolled psychiatric disorder (including history of hospitalization for psychiatric illness).

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetes type2
• Time Restricted Feeding

Intervention

Behavioral:
• Time-Restricted Eating
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.
• Standard of Care
Participants in the Standard of Care group will continue to follow their physician's treatment plan for type II diabetes mellitus.

Locations

Country	Name	City	State
United States	Altman Clinical and Translational Research Institute	La Jolla	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Diego	Salk Institute for Biological Studies

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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).	Any hypoglycemic events reported from daily finger pricks will be reported	Baseline through 3 months
Other	Long term TRE adherence	Ability to self-sustain TRE assessed via logging on the mCC app 2 weeks/month. [Timeframe: 3-month to 6-month follow-up]	3-month to 6-month follow-up
Primary	Glycemic regulation assessed by HbA1c	Change in blood glucose assessed via hemoglobin A1c.	Baseline and 3 months
Secondary	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.	Baseline and 3 months
Secondary	Fasting plasma glucose (mg/dL)	Change in glycemic regulation as assessed fasting plasma glucose (mg/dL).	Baseline and 3 months
Secondary	Fasting plasma insulin (mIU/L)	Change in glycemic regulation as assessed changes in fasting plasma insulin (mIU/L).	Baseline and 3 months
Secondary	HOMA-IR	Change in glycemic regulation as assessed by HOMA-IR.	Baseline and 3 months
Secondary	LDL Particle Number (nmol/L)	Changes in atherogenic lipids assessed via LDL Particle Number (nmol/L) via NMR Lipoproteinprofile.	Baseline and 3 months
Secondary	Non-HDL Cholesterol (mg/dL)	Changes in atherogenic lipids assessed via Non-HDL Cholesterol (mg/dL).	Baseline and 3 months
Secondary	Triglycerides (mg/dL)	Changes in atherogenic lipids assessed via Triglycerides (mg/dL).	Baseline and 3 months
Secondary	Apolipoprotein B (ApoB)	Changes in atherogenic lipids assessed via ApoB (mg/dL).	Baseline and 3 months
Secondary	Quality of life Assessment via Short Form-36 Questionnaire (SF-36)	Changes in quality of life as assessed by the SF-36 questionnaire.	Baseline and 3 months