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

NCT05365529 | Recruiting

• 1 other identifier: 801955
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Diabetes Mellitus, Type 2; Time Restricted Feeding; Diabetes Type2

Outcome Measures

Primary Outcomes (1)

• Glycemic regulation assessed by HbA1c

  Change in blood glucose assessed via hemoglobin A1c.

  Baseline and 3 months

Secondary Outcomes (9)

• Glycemic regulation assessed by Continuous Glucose Monitor (CGM)

  Baseline and 3 months

• Fasting plasma glucose (mg/dL)

  Baseline and 3 months

• Fasting plasma insulin (mIU/L)

  Baseline and 3 months

• HOMA-IR

  Baseline and 3 months

• LDL Particle Number (nmol/L)

  Baseline and 3 months

Other Outcomes (2)

• 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).

  Baseline through 3 months

• Long term TRE adherence

  3-month to 6-month follow-up

Study Arms (2)

Standard of Care

PLACEBO COMPARATOR

The participants in this arm will receive the standard health and nutritional wellness guidelines and will be required to log food entries through the use of a smartphone app.

Behavioral: Standard of Care

Time-Restricted Eating

EXPERIMENTAL

The participants in this arm will limit the number of hours they eat in day to a 8-10-hour window and will also receive the standard health and nutritional wellness guidelines. They will also be required to log food entries through the use of a smartphone app.

Behavioral: Time-Restricted Eating

Interventions

Time-Restricted Eating BEHAVIORAL

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.

Also known as: Time Restricted Feeding

Time-Restricted Eating

Standard of Care BEHAVIORAL

Participants in the Standard of Care group will continue to follow their physician's treatment plan for type II diabetes mellitus.

Also known as: Control group

Standard of Care

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18-75 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) \> 30mL/min/1.73m2
• 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.

You may not qualify if:

• Participants with Type1DM and T2DM who are taking insulin, sulfonylureas, or have an HbA1c \> 9 %.
• BMI \> 50 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),
• 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.
• 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 \< 30mL/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).

Sponsors & Collaborators

• University of California, San Diego: lead
• Salk Institute for Biological Studies: collaborator

Study Sites (1)

Altman Clinical and Translational Research Institute

La Jolla, California, 92093, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 35732151 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Intermittent Fasting

Interventions

Standard of Care; Control Groups

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Fasting; Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Pam Taub, MD

  Professor of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Justina P Nguyen, BS

CONTACT

858-246-2406; preventivecvresearch@health.ucsd.edu

David T Van, BS

CONTACT

858-246-2342

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: March 10, 2022
• First Posted: May 9, 2022
• Study Start: May 16, 2022
• Primary Completion: December 1, 2025
• Study Completion: March 1, 2026
• Last Updated: October 8, 2024

Record last verified: 2024-10

Locations

US (1)