Time-Restricted Eating for Type 2 Diabetes
(TRE-T2D Trial)
Recruiting in Palo Alto (17 mi)
Overseen byPam Taub, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of California, San Diego
Must be taking: GLP-1 receptor agonists
Must not be taking: Insulin, Sulfonylureas
Disqualifiers: Type 1 diabetes, Obesity, Hypertension, Hyperlipidemia, others
Trial Summary
What is the purpose of this trial?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).
Will I have to stop taking my current medications?
The trial does not require you to stop taking your current medications. However, if you are on cardiovascular medications or GLP-1 receptor agonists, you must stay on stable doses without any changes during the study.
What data supports the effectiveness of the treatment Time-Restricted Eating for Type 2 Diabetes?
Research suggests that intermittent fasting, which includes time-restricted eating, may help improve blood sugar control and aid in weight loss for people with type 2 diabetes. This approach is thought to improve how the body manages glucose (sugar) and may even help reverse some of the underlying issues of diabetes.
12345Is time-restricted eating safe for people with type 2 diabetes?
Existing studies suggest that time-restricted eating is generally safe for people with type 2 diabetes, as long as their medication is monitored and adjusted. However, more research is needed to make specific recommendations about its safety and effectiveness.
13678How is time-restricted eating different from other treatments for type 2 diabetes?
Time-restricted eating (TRE) is unique because it focuses on limiting the hours during which you eat each day, typically to an 8-10 hour window, rather than changing what you eat. This approach is different from other treatments that may involve medication or specific dietary changes, and it aims to improve blood sugar control and weight management by aligning eating patterns with the body's natural rhythms.
19101112Eligibility Criteria
This trial is for adults aged 18-70 with type 2 diabetes, A1c levels between 6.5 and 9.0%, who own a smartphone and eat over a period of ≥12 hours/day. They must be on stable medication doses, not adjusting cardiovascular meds during the study, and have an EGFR >50. Exclusions include severe chronic conditions, psychiatric disorders, BMI >40 kg/m2, active substance use, certain medications including weight loss drugs or appetite suppressants.Inclusion Criteria
I am on a stable dose of GLP-1 receptor agonist medication.
I will take a pregnancy test and use birth control during the study.
I have type 2 diabetes with an A1c level between 6.5% and 9.0%, and I can walk on my own.
+6 more
Exclusion Criteria
Uncontrolled psychiatric disorder (including history of hospitalization for psychiatric illness)
My kidney function is low, with an eGFR under 50 mL/min.
I have had adrenal gland problems in the past.
+27 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants follow either standard of care or time-restricted eating for 12 weeks
12 weeks
Regular clinic visits and virtual consultations
Follow-up
Participants are monitored for safety and effectiveness after treatment
3 months
Follow-up assessment at 6 months
Participant Groups
The trial tests if time-restricted eating (TRE), where participants eat within an 8-10 hour window daily alongside standard care (SOC), improves glucose regulation and heart health in type 2 diabetes patients compared to SOC alone.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Time-Restricted EatingExperimental Treatment1 Intervention
The participants in this arm will limit the number of hours they eat in day to a 8-10-hour window and will also receive the standard health and nutritional wellness guidelines. They will also be required to log food entries through the use of a smartphone app.
Group II: Standard of CarePlacebo Group1 Intervention
The participants in this arm will receive the standard health and nutritional wellness guidelines and will be required to log food entries through the use of a smartphone app.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Altman Clinical and Translational Research InstituteLa Jolla, CA
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Who Is Running the Clinical Trial?
University of California, San DiegoLead Sponsor
Salk Institute for Biological StudiesCollaborator
References
Designing a Co-created Intervention to Promote Motivation and Maintenance of Time-Restricted Eating in Individuals With Overweight and Type 2 Diabetes. [2023]To design an appealing time-restricted eating (TRE) intervention by exploring behavioral and social mechanisms to improve TRE adoption and maintenance among people with type 2 diabetes (T2D) and overweight. Time-restricted eating is an intermittent fasting regimen suggested to improve glycemic control and body weight.
INTERmittent FASTing in people with insulin-treated type 2 diabetes mellitus - the INTERFAST-2 study protocol. [2023]Intermittent fasting, a dietary intervention of alternate eating and fasting, has gained popularity in people trying to lose weight. Intermittent fasting could provide an alternative to classic caloric restriction in people with type 2 diabetes mellitus. The aim of the study is to determine the impact of a 12-week intermittent fasting regimen compared with usual care in people with type 2 diabetes mellitus receiving insulin therapy.
Intermittent fasting versus continuous energy-restricted diet for patients with type 2 diabetes mellitus and metabolic syndrome for glycemic control: A systematic review and meta-analysis of randomized controlled trials. [2021]To compare the safety of intermittent fasting (IF) with that of continuous energy-restricted diets (CERD) in patients with T2DM and metabolic syndrome who were overweight or obese and assess their effects on glycemic control and weight loss.
A Review of Intermittent Fasting as a Treatment for Type 2 Diabetes Mellitus. [2023]Introduction: The purpose of this review is to explore intermittent fasting (IF) versus continuous energy restriction as a treatment of Type 2 Diabetes Mellitus (T2DM). The precursor to diabetes is obesity, which currently threatens the Department of Defense's ability to retain and recruit adequate service members. Intermittent fasting may be an adjunct for prevention of obesity and diabetes in the armed forces.
Intermittent Fasting as Part of the Management for T2DM: from Animal Models to Human Clinical Studies. [2020]Diet is a pillar of type 2 diabetes mellitus (T2DM) management. Intermittent fasting (IF) is postulated as a novel approach, able to improve glucose control and potentially capable of reversing some of the pathophysiological alterations of this condition. In this review, the molecular and clinical evidence of diets based on intermittent energy restriction (IER) in laboratory animal models and subjects with type 2 diabetes is discussed. The mechanisms through which IF are thought to improve glucose homeostasis and reverse β cell failure are also reviewed.
Is Time-Restricted Eating Safe in the Treatment of Type 2 Diabetes?-A Review of Intervention Studies. [2022]Time-restricted eating (TRE) has been shown to improve body weight and glucose metabolism in people at high risk of type 2 diabetes. However, the safety of TRE in the treatment of type 2 diabetes is unclear. We investigated the safety of TRE interventions in people with type 2 diabetes by identifying published and ongoing studies. Moreover, we identified the commonly used antidiabetic drugs and discussed the safety of TRE in people with type 2 diabetes considering the use of these drugs. In addition, we addressed the research needed before TRE can be recommended in the treatment of type 2 diabetes. A literature search was conducted to identify published (MEDLINE PubMed) and ongoing studies (ClinicalTrials.gov) on TRE in people with type 2 diabetes. To assess the usage of antidiabetic drugs and to discuss pharmacodynamics and pharmacokinetics in a TRE context, the most used antidiabetic drugs were identified and analysed. Statistics regarding sale of pharmaceuticals were obtained from MEDSTAT.DK which are based on data from the national Register of Medicinal Product Statistics, and from published studies on medication use in different countries. Four published studies investigating TRE in people with type 2 diabetes were identified as well as 14 ongoing studies. The completed studies suggested that TRE is safe among people with type 2 diabetes. Common antidiabetic drugs between 2010 and 2019 were metformin, insulin, dipeptidyl peptidase-4 inhibitors, glucagon-like peptide-1 receptor agonists, sulfonylureas, and sodium-glucose cotransporter-2 inhibitors. Existing studies suggest that TRE is not associated with major safety issues in people with type 2 diabetes as long as medication is monitored and adjusted. However, because of low generalisability of the few studies available, more studies are needed to make concrete recommendations regarding efficacy and safety of TRE in people with type 2 diabetes.
Intermittent fasting interventions for the treatment of overweight and obesity in adults aged 18 years and over: a systematic review protocol. [2022]Are intermittent fasting interventions an effective treatment for overweight and obesity in adults, when compared to usual care treatment (continuous daily energy restriction - reduced calorie diet) or no treatment (ad libitum diet)?
Safety of alternate day fasting and effect on disordered eating behaviors. [2018]Alternate day fasting (ADF; ad libitum intake "feed day" alternated with 75% restriction "fast day"), is effective for weight loss, but the safety of the diet has been questioned. Accordingly, this study examined occurrences of adverse events and eating disorder symptoms during ADF.
Time-Restricted Eating as a Nutrition Strategy for Individuals with Type 2 Diabetes: A Feasibility Study. [2022]Individuals with type 2 diabetes (T2D) require a long-term dietary strategy for blood glucose management and may benefit from time-restricted eating (TRE, where the duration between the first and last energy intake is restricted to 8-10 h/day). We aimed to determine the feasibility of TRE for individuals with T2D. Participants with T2D (HbA1c >6.5 to <9%, eating window >12 h/day) were recruited to a pre-post, non-randomised intervention consisting of a 2-week Habitual period to establish baseline dietary intake, followed by a 4-weeks TRE intervention during which they were instructed to limit all eating occasions to between 10:00 and 19:00 h on as many days of each week as possible. Recruitment, retention, acceptability, and safety were recorded throughout the study as indicators of feasibility. Dietary intake, glycaemic control, psychological well-being, acceptability, cognitive outcomes, and physiological measures were explored as secondary outcomes. From 594 interested persons, and 27 eligible individuals, 24 participants enrolled and 19 participants (mean ± SD; age: 50 ± 9 years, BMI: 34 ± 5 kg/m2, HbA1c: 7.6 ± 1.1%) completed the 6-week study. Overall daily dietary intake did not change between Habitual (~8400 kJ/d; 35% carbohydrate, 20% protein, 41% fat, 1% alcohol) and TRE periods (~8500 kJ/d; 35% carbohydrate, 19% protein, 42% fat, 1% alcohol). Compliance to the 9 h TRE period was 72 ± 24% of 28 days (i.e., ~5 days/week), with varied adherence (range: 4-100%). Comparisons of adherent vs. non-adherent TRE days showed that adherence to the 9-h TRE window reduced daily energy intake through lower absolute carbohydrate and alcohol intakes. Overall, TRE did not significantly improve measures of glycaemic control (HbA1c -0.2 ± 0.4%; p = 0.053) or reduce body mass. TRE did not impair or improve psychological well-being, with variable effects on cognitive function. Participants described hunger, daily stressors, and emotions as the main barriers to adherence. We demonstrate that 4-weeks of TRE is feasible and achievable for these individuals with T2D to adhere to for at least 5 days/week. The degree of adherence to TRE strongly influenced daily energy intake. Future trials may benefit from supporting participants to incorporate TRE in regular daily life and to overcome barriers to adherence.
Effect of Time-Restricted Eating on Weight Loss in Adults With Type 2 Diabetes: A Randomized Clinical Trial. [2023]Time-restricted eating (TRE) has become increasingly popular, yet longer-term randomized clinical trials have not evaluated its efficacy and safety in patients with type 2 diabetes (T2D).
Feasibility of time-restricted eating in individuals with overweight, obesity, prediabetes, or type 2 diabetes: A systematic scoping review. [2023]This systematic scoping review aimed to map and synthesize research on feasibility of time-restricted eating (TRE) in individuals with overweight, obesity, prediabetes, or type 2 diabetes, including recruitment rate, retention rate, safety, adherence, and participants' attitudes, experiences, and perspectives.
Time-restricted eating did not alter insulin sensitivity or β-cell function in adults with obesity: A randomized pilot study. [2023]Decreased insulin sensitivity and impairment of β-cell function predate and predict development of type 2 diabetes mellitus. Time-restricted eating (TRE) might have a benefit for these parameters. The objective of this pilot study was to investigate this possibility.