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New treatment option for Type 2 Diabetes
Official title Time Restricted-EAting for Type 2 Diabetes and MEtabolic Health: the TEA TIME Trial
ClinicalTrials.gov ID: NCT07272460
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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)...
- Ability to read and understand English
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.