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NCT Number: NCT07272460

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

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.

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Key information

Conditions

Type 2 Diabetes Behavior Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Fasting Feeding Behavior Glucose Metabolism Disorders Intermittent Fasting Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Overweight (BMI > 25) Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Leadership Sinai Centre for Diabetes

Toronto, Ontario, M5T3L9, Canada

Location status: Recruiting

Location contact

Kramer

CONTACT

[email protected]

+1416-586-4800 ext. 7628

About this study

In this study, eligible patients with type 2 diabetes will be randomized to either time-restricted eating or standard lifestyle. The hypothesis under study is whether time-restricted eating can improve pancreatic beta-cell function.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Individuals with previously diagnosed BMI ≥ 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

Exclusion criteria

  • 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

Treatment and study plan

Time-restricted eating

Behavioral

18 hours of fasting and 6 hour window of eating (between 2 to 8 PM) every day for 52 weeks.

Standard lifestyle

Behavioral

standard lifestyle recommendations as per Diabetes Canada guidelines [where patients are encouraged to maintain regularity in timing and spacing of meals with no specific recommendation regarding hours of fasting]

Primary outcomes

  1. Differences in baseline-adjusted Insulin-Secretion-Sensitivity Index-2 (ISSI-2) between the study groups.

    Time frame: 52-weeks

    Baseline-adjusted beta-cell function at 52 weeks, measured by Insulin Secretion-Sensitivity Index-2 (ISSI-2).

Secondary outcomes

  1. Differences in baseline-adjusted insulin resistance between the study groups

    Time frame: 52-weeks

    Baseline-adjusted insulin resistance at 52-weeks measured by HOMA-IR

  2. Differences in time in glucose target range between each study group

    Time frame: 52-weeks

    Time in glucose target range indicates the amount of time (in %) that glucose readings are within the defined target glucose range of 3.9-10.0 mmol/L.

Other outcomes

  1. Anthropometric measures

    Time frame: 52-weeks

    Differences in body weight (kg) between each study arm

  2. Additional measures of beta-cell function

    Time frame: 52-weeks

    Insulinogenic index/HOMA-IR.

  3. Additional measures of insulin sensitivity

    Time frame: 52-weeks

    Matsuda Index

  4. Time above glucose target on isCGM

    Time frame: 52 weeks

    Differences between each study arm in time-above target of 10 mmol/l (%) obtained by isCGM (FreeStyle Libre devices).

  5. Additional anthropometric measures

    Time frame: 52 weeks

    Differences in waist circumference between the study arms

Study contacts

Contact information is provided by the study sponsor or research team.

Caroline K Kramer, MD, PhD

CONTACT

[email protected]

+1-416-586-4800 ext. 7628

Sponsors and collaborators

Lead sponsor

Mount Sinai Hospital, Canada

Other

Registry information

Official study title

Time Restricted-eating and Metabolic Health in Patients With Type 2 Diabetes

Acronym: TEA-TIME

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Dec 9, 2025
Registry last updated
Feb 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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