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

Primary Purpose

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

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Time-Restricted Eating
Standard of Care
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Altman Clinical and Translational Research InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Standard of Care

Time-Restricted Eating

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Glycemic regulation assessed by HbA1c
Change in blood glucose assessed via hemoglobin A1c.

Secondary Outcome Measures

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.
Fasting plasma glucose (mg/dL)
Change in glycemic regulation as assessed fasting plasma glucose (mg/dL).
Fasting plasma insulin (mIU/L)
Change in glycemic regulation as assessed changes in fasting plasma insulin (mIU/L).
HOMA-IR
Change in glycemic regulation as assessed by HOMA-IR.
LDL Particle Number (nmol/L)
Changes in atherogenic lipids assessed via LDL Particle Number (nmol/L) via NMR Lipoproteinprofile.
Non-HDL Cholesterol (mg/dL)
Changes in atherogenic lipids assessed via Non-HDL Cholesterol (mg/dL).
Triglycerides (mg/dL)
Changes in atherogenic lipids assessed via Triglycerides (mg/dL).
Apolipoprotein B (ApoB)
Changes in atherogenic lipids assessed via ApoB (mg/dL).
Quality of life Assessment via Short Form-36 Questionnaire (SF-36)
Changes in quality of life as assessed by the SF-36 questionnaire.

Full Information

First Posted
March 10, 2022
Last Updated
August 9, 2023
Sponsor
University of California, San Diego
Collaborators
Salk Institute for Biological Studies
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1. Study Identification

Unique Protocol Identification Number
NCT05365529
Brief Title
Time-Restricted Eating for Type II Diabetes: TRE-T2D
Acronym
TRE-T2D
Official Title
Feasibility and Efficacy of Time-Restricted Eating in Diabetes Management
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 16, 2022 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
March 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego
Collaborators
Salk Institute for Biological Studies

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Time Restricted Feeding, Diabetes type2

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Time-Restricted Eating
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Time-Restricted Eating
Other Intervention Name(s)
Time Restricted Feeding
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard of Care
Other Intervention Name(s)
Control group
Intervention Description
Participants in the Standard of Care group will continue to follow their physician's treatment plan for type II diabetes mellitus.
Primary Outcome Measure Information:
Title
Glycemic regulation assessed by HbA1c
Description
Change in blood glucose assessed via hemoglobin A1c.
Time Frame
Baseline and 3 months
Secondary Outcome Measure Information:
Title
Glycemic regulation assessed by Continuous Glucose Monitor (CGM)
Description
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
Title
Fasting plasma glucose (mg/dL)
Description
Change in glycemic regulation as assessed fasting plasma glucose (mg/dL).
Time Frame
Baseline and 3 months
Title
Fasting plasma insulin (mIU/L)
Description
Change in glycemic regulation as assessed changes in fasting plasma insulin (mIU/L).
Time Frame
Baseline and 3 months
Title
HOMA-IR
Description
Change in glycemic regulation as assessed by HOMA-IR.
Time Frame
Baseline and 3 months
Title
LDL Particle Number (nmol/L)
Description
Changes in atherogenic lipids assessed via LDL Particle Number (nmol/L) via NMR Lipoproteinprofile.
Time Frame
Baseline and 3 months
Title
Non-HDL Cholesterol (mg/dL)
Description
Changes in atherogenic lipids assessed via Non-HDL Cholesterol (mg/dL).
Time Frame
Baseline and 3 months
Title
Triglycerides (mg/dL)
Description
Changes in atherogenic lipids assessed via Triglycerides (mg/dL).
Time Frame
Baseline and 3 months
Title
Apolipoprotein B (ApoB)
Description
Changes in atherogenic lipids assessed via ApoB (mg/dL).
Time Frame
Baseline and 3 months
Title
Quality of life Assessment via Short Form-36 Questionnaire (SF-36)
Description
Changes in quality of life as assessed by the SF-36 questionnaire.
Time Frame
Baseline and 3 months
Other Pre-specified Outcome Measures:
Title
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).
Description
Any hypoglycemic events reported from daily finger pricks will be reported
Time Frame
Baseline through 3 months
Title
Long term TRE adherence
Description
Ability to self-sustain TRE assessed via logging on the mCC app 2 weeks/month. [Timeframe: 3-month to 6-month follow-up]
Time Frame
3-month to 6-month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Justina P Nguyen, BS
Phone
858-246-2406
Email
preventivecvresearch@health.ucsd.edu
First Name & Middle Initial & Last Name or Official Title & Degree
David T Van, BS
Phone
858-246-2342
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pam Taub, MD
Organizational Affiliation
Professor of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Altman Clinical and Translational Research Institute
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Justina P Nguyen, BS
Phone
858-246-2406
Email
preventivecvresearch@health.ucsd.edu
First Name & Middle Initial & Last Name & Degree
David T Van, BS
Phone
858-246-2342
First Name & Middle Initial & Last Name & Degree
Pam R Taub, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
35732151
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.
Results Reference
derived

Learn more about this trial

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

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