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

ConditionsType 2 DiabetesOverweight (BMI > 25)
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • 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 \[where patients are encouraged to maintain regularity in timing and spacing of meals with no specific recommendation regarding hours of fasting\]

Treatment groups

112 Participants
are divided into 2 treatment groups
Group A: Time-restricted eatingExperimental treatment 1 intervention
Group B: Standard lifestyleActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

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

Time frame
52-weeks

Secondary outcomes

1

Differences in baseline-adjusted insulin resistance between the study groups

Baseline-adjusted insulin resistance at 52-weeks measured by HOMA-IR

Time frame
52-weeks
2

Differences in time in glucose target range between each study group

Time in glucose target range indicates the amount of time (in %) that glucose readings are within the defined target glucose range of 3.9-10.0 mmol/L.

Time frame
52-weeks

Other outcomes

1

Anthropometric measures

Differences in body weight (kg) between each study arm

Time frame
52-weeks
2

Additional measures of beta-cell function

Insulinogenic index/HOMA-IR.

Time frame
52-weeks
3

Additional measures of insulin sensitivity

Matsuda Index

Time frame
52-weeks
4

Time above glucose target on isCGM

Differences between each study arm in time-above target of 10 mmol/l (%) obtained by isCGM (FreeStyle Libre devices).

Time frame
52 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mount Sinai Hospital, Canada

Lead sponsor

Source ClinicalTrials.gov
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