← Back to Search

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 with T2DM with A1c between 6.5 and 9.0 % and on stable doses of medications who are weight-bearing and self-ambulatory

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

Must not have

Chronic kidney disease with an eGFR calculated based on the Modification of Diet in Renal Disease (MDRD) equation <50mL/min/1.73m2

History of adrenal disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3-month to 6-month follow-up

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have type 2 diabetes with an A1c level between 6.5% and 9.0%, and I can walk on my own.

Select...

I am not changing my heart or cholesterol medication doses during the study.

Select...

I am between 18 and 70 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My kidney function is low, with an eGFR under 50 mL/min.

Select...

I have had adrenal gland problems in the past.

Select...

I am receiving treatment for an inflammatory, rheumatologic disease, or cancer.

Select...

I have liver cirrhosis or significant liver function issues.

Select...

I am currently on medication for weight loss or that suppresses my appetite.

Select...

I plan to travel across time zones with a 3+ hour difference during the study.

Select...

I have a history of HIV/AIDS.

Select...

I have been diagnosed with type I diabetes.

Select...

I haven't had any major heart or stroke events in the last year.

Select...

I have diabetes and take insulin or specific medications, or my HbA1c is above 9%.

Select...

I have advanced chronic kidney disease or am on dialysis.

Select...

I have had surgery for weight management or have an active eating disorder.

Select...

I have not had a major heart or stroke event in the last 6 months.

Select...

I have a diagnosed inflammatory or rheumatologic condition.

Select...

I am currently being treated for cancer, except for non-melanoma skin cancer.

Select...

My blood pressure is higher than 160/110 mmHg, with or without medication.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3-month to 6-month follow-up

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Glycemic regulation assessed by HbA1c

Secondary study objectives

Apolipoprotein B (ApoB)

Fasting plasma glucose (mg/dL)

Fasting plasma insulin (mIU/L)

+6 more

Other study objectives

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).

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

0 / 19Eligibility criteria met