Time Restricted-EAting for Type 2 Diabetes and MEtabolic Health: the TEA TIME Trial
Recruiting · NCT07272460 · Interventional (participants receive a specific treatment) · Lead sponsor: Mount Sinai Hospital, Canada
View the official record on ClinicalTrials.gov →Interventions studied
Standard lifestyleTime-restricted eating
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.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- Leadership Sinai Centre for Diabetes - Toronto, Ontario, Canada