Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
NCT07272460

Time Restricted-EAting for Type 2 Diabetes and MEtabolic Health: the TEA TIME Trial

Led by Mount Sinai Hospital, Canada · Updated on 2026-02-11

112

Participants Needed

1

Research Sites

182 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Time-restricted eating - where no food is consumed over a period of time - has been shown to promote weight loss and improve cardio-metabolic function. In individuals with type 2 diabetes, it is also been shown to improve glucose control. The investigators propose a randomized controlled trial to determine whether time-restricted eating is an effective therapeutic strategy that can preserve pancreatic beta-cell function and improve glycemic control early in participants with type 2 diabetes.

CONDITIONS

Official Title

Time Restricted-EAting for Type 2 Diabetes and MEtabolic Health: the TEA TIME Trial

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Individuals with previously diagnosed BMI 25 25 kg/m2 and type 2 diabetes within preceding 10 years
  • Age 18 - 75 years inclusive
  • Stable weight over past 12 weeks (less than 5% change in body weight) (self-reported)
  • Diabetes treatment consisting of lifestyle only or metformin, dipeptidyl peptidase-4 (DPP-4) inhibitor, and sodium-glucose co-transporter 2 (SGLT2) inhibitors either as monotherapy or in combination
  • Ability to read and understand English
Not Eligible

You will not qualify if you...

  • Current diabetes treatment with insulin, glucagon-like peptide-1 receptor agonists, and/or sulfonylureas
  • Use of any other pharmacological treatment for weight-loss
  • Previous surgical treatment for weight loss such as gastric bypass or gastric band
  • Any history of eating disorder
  • Currently pregnant or lactating
  • Renal dysfunction as evidenced by estimated glomerular filtration rate < 25 ml/min by CKD-EPI Creatinine Equation
  • New York Heart Association class II-IV heart failure
  • Hepatic disease considered to be clinically significant (includes jaundice, chronic hepatitis, or previous liver transplant) or transaminases >2.5X the upper limit of normal
  • Malignant neoplasm requiring chemotherapy, surgery, radiation or palliative therapy within the previous 5 years (with the exception of basal cell skin cancer)
  • Any other factor likely to limit adherence to the study, in the opinion of the investigators
  • Concurrent participation in another research study relevant to diabetes and metabolic health

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Leadership Sinai Centre for Diabetes

Toronto, Ontario, Canada, M5T3L9

Actively Recruiting

Loading map...

Research Team

C

Caroline K Kramer, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Time Restricted-EAting for Type 2 Diabetes and MEtabolic Health: the TEA TIME Trial | DecenTrialz