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Time-Restricted Eating for Type 2 Diabetes (TRE-T2D Trial)

N/A
Recruiting
Led By Pam Taub, MD
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients on stable doses of GLP-1 receptor agonists will be included
Patients with T2DM with A1c between 6.5 and 9.0 % and on stable doses of medications who are weight-bearing and self-ambulatory
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3-month to 6-month follow-up
Awards & highlights

TRE-T2D Trial Summary

This trial will see if time-restricted eating can help improve the health of people with type 2 diabetes. Two groups will either follow their current care plan or add in time-restricted eating, which means only eating during an 8-10 hour window.

Who is the study for?
This trial is for adults aged 18-70 with type 2 diabetes, A1c levels between 6.5 and 9.0%, who own a smartphone and eat over a period of ≥12 hours/day. They must be on stable medication doses, not adjusting cardiovascular meds during the study, and have an EGFR >50. Exclusions include severe chronic conditions, psychiatric disorders, BMI >40 kg/m2, active substance use, certain medications including weight loss drugs or appetite suppressants.Check my eligibility
What is being tested?
The trial tests if time-restricted eating (TRE), where participants eat within an 8-10 hour window daily alongside standard care (SOC), improves glucose regulation and heart health in type 2 diabetes patients compared to SOC alone.See study design
What are the potential side effects?
Since this study involves dietary changes rather than medication or invasive procedures, side effects may include hunger outside of eating windows or potential changes in energy levels but are generally expected to be minimal.

TRE-T2D Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am on a stable dose of GLP-1 receptor agonist medication.
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I have type 2 diabetes with an A1c level between 6.5% and 9.0%, and I can walk on my own.
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I will take a pregnancy test and use birth control during the study.
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I am post-menopausal or on hormone replacement therapy.
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I am not changing my heart or cholesterol medication doses during the study.
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I am between 18 and 70 years old.

TRE-T2D Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3-month to 6-month follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3-month to 6-month follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Glycemic regulation assessed by HbA1c
Secondary outcome measures
Apolipoprotein B (ApoB)
Fasting plasma glucose (mg/dL)
Fasting plasma insulin (mIU/L)
+6 more
Other outcome measures
Long term TRE adherence
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).

TRE-T2D Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Time-Restricted EatingExperimental Treatment1 Intervention
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.
Group II: Standard of CarePlacebo Group1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Time-Restricted Eating
2019
N/A
~160

Find a Location

Who is running the clinical trial?

University of California, San DiegoLead Sponsor
1,117 Previous Clinical Trials
1,520,228 Total Patients Enrolled
Salk Institute for Biological StudiesOTHER
19 Previous Clinical Trials
1,747 Total Patients Enrolled
Pam Taub, MDPrincipal InvestigatorProfessor of Medicine
8 Previous Clinical Trials
1,116 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the maximum allowable enrollment for this research project?

"Affirmative. The clinicaltrials.gov database suggests that this research is currently open to participants, with the initial posting dating back to May 16th 2022 and a recent edit made on June 17th 2022. Sixty patients are required for enrollment at one site."

Answered by AI

Might I be eligible to join this trial?

"This clinical trial seeks 60 volunteers who, between 18 and 70 years of age, have been diagnosed with type 2 diabetes mellitus. In order to join the study, potential candidates must also fulfil a range of criteria: - Age: 18-70 years old - A1c measurement values 6.5%-9.0% on stable medication doses- Weight bearing and self ambulation abilities - Ownership of either an Apple iOS or Android OS smartphones - Eating period ≥12 hours/day in addition to consistent logging through mCC application - Post menopausal women as well as those taking hormone"

Answered by AI

Are there currently opportunities to join this experiment?

"Affirmative. Clinicaltrials.gov's records show that this clinical trial is currently trying to recruit individuals; it was first posted on May 16th 2022 and the most recent update was June 17th 2022. The research team needs 60 patients from 1 medical location for the study."

Answered by AI

Is there an upper age limit to enrolment in this investigation?

"The parameters for this research project include an age range of 18-70. There are 193 studies involving people younger than the specified lower bound and 1077 studies conducted with individuals beyond 65 years old."

Answered by AI
~29 spots leftby Dec 2025