Time-Restricted Eating for Type II Diabetes: TRE-T2D (NCT05365529) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Time-Restricted Eating for Type II Diabetes: TRE-T2D
United States60 participantsStarted 2022-05-16
Plain-language summary
This is a randomized clinical trial to assess the feasibility and efficacy of time-restricted eating (TRE) to improve glucose regulation and cardiovascular health of participants with type 2 diabetes mellitus (T2DM). Participants will be randomized into 2 groups: 1) standard of care (SOC), in which they will continue to follow their physician's treatment plan, or 2) SOC and TRE (8-10 hours eating window).
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age: 18-75 years old
. Patients with T2DM with A1c between 6.5 and 9.0 % and on stable doses of medications who are weight-bearing and self-ambulatory.
. Own a smartphone (Apple iOS or Android OS)
. Baseline eating period ≥12 hours/day and sufficient logging on the mCC app.
. Women of childbearing age will be given a pregnancy test on study enrollment and asked to use contraception throughout the study.
. Post-menopausal and women on hormone replacement therapy will be included.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is studying time-restricted eating — meaning eating only within a set window of hours each day — as a way to manage blood sugar in type 2 diabetes; is this something that could realistically work with my current eating habits, work schedule, and lifestyle?
2The trial is measuring HbA1c as its main outcome, which reflects average blood sugar over about three months — based on where my HbA1c currently sits, do you think a dietary timing approach like this is likely to move the needle enough for someone in my situation?
3Since this study has no listed phase, it's not a drug trial in the traditional sense, but it is a structured research intervention — what are the potential risks or downsides of following a strict time-restricted eating schedule, especially given any other health conditions or medications I'm on?
4The trial is listed as active but no longer recruiting, so I can't enroll — but could you help me understand whether time-restricted eating is something we could try as part of my regular care plan, based on what studies like this one have found so far?
5Before exploring options like this, should I focus on standard treatments for type 2 diabetes first, and how would you compare the evidence behind time-restricted eating to more established approaches like medication or a conventional dietary plan?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. If participants are on cardiovascular medications (HMG CoA reductase inhibitors (statins), other lipid-modifying drugs, anti-hypertensives) no dose adjustments will be allowed during the study period
Exclusion criteria
0. Participants with Type1DM and T2DM who are taking insulin, sulfonylureas, or have an HbA1c \> 9 %.
1. BMI \> 50 kg/m2
2. Systolic BP greater than 160 mmHg and/or Diastolic BP greater than 110 mmHg (with or without treatment/medication)
3. LDL cholesterol greater than 200 mg/dL
4. Triglycerides greater than 500 mg/dL
5. Active tobacco or illicit drug use
6. Pregnant or breastfeeding women.
7. Currently enrolled in a weight-loss or weight-management program,