Time Restricted-EAting for Type 2 Diabetes and MEtabolic Health: the TEA TIME Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorMount Sinai Hospital, Canada
About this 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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Time-restricted eating
- Standard lifestyle
Treatment groups
112 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov