Clinical trial

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

Recruiting now · Not applicable · 1 countries · Registry ID NCT07272460

Recruiting nowNot applicableInterventional

What this study 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 75 Years

SexAll

Healthy volunteersNot accepted

ConditionType 2 Diabetes, Overweight (BMI > 25)

Full registry criteria

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

Treatments and study arms

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

Differences in baseline-adjusted Insulin-Secretion-Sensitivity Index-2 (ISSI-2) between the study groups.52-weeks

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

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Leadership Sinai Centre for Diabetes🇨🇦 Toronto, Ontario, Canada

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KramerContact

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