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

Mount Sinai Hospital, Canada

Status: Not yet enrolling

Conditions: Overweight (BMI > 25); Type 2 Diabetes

Treatments: Behavioral: Standard lifestyle; Behavioral: Time-restricted eating

Study type: Interventional

Funder types: Other

Identifiers

NCT07272460

REB # 0002

Details and patient eligibility

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.

Full description

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.

Enrollment: 112 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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112 participants in 2 patient groups

Time-restricted eating

Experimental group

Description:

Time-restricted eating protocol consisting of time-restricted eating with 18 hours of fasting and 6 hour window of eating (between 2 to 8 PM) every day.

Treatment:

Behavioral: Time-restricted eating

Standard lifestyle

Active Comparator group

Description:

Standard lifestyle recommendation as per Diabetes Canada Guidelines.

Treatment:

Behavioral: Standard lifestyle