Time-Restricted Eating for Type 2 Diabetes

(TRE-T2D Trial)

Overseen By David T Van, BS

Age: 18+

Sex: Any

Trial Phase: Academic

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

Compensation: Varies

Number of Visits: 6

Duration: 12 weeks

60 Participants Needed

What You Need to Know Before You Apply

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.

Is 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. ^{1 2 3 4 5}

How 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. ^{2 6 7 8 9}

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. ^{1 2 10 11 12}

Who Is on the Research Team?

Pam Taub, MD

Principal Investigator

Professor of Medicine

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Standard of Care
• Time-Restricted Eating

Trial Overview 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.

How Is the Trial Designed?

Group I: Time-Restricted Eating Experimental Treatment 1 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 Care Placebo Group 1 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.

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

Salk Institute for Biological Studies

Collaborator

Trials

23

Recruited

2,200+

Published Research Related to This Trial

A time-restricted eating (TRE) intervention designed for people with type 2 diabetes and overweight includes a two-phase approach: an initial strict phase followed by a more flexible phase tailored to individual needs.

Support from healthcare professionals, family, and peers is crucial for maintaining motivation and adherence to the TRE regimen, emphasizing a whole-person approach that considers participants' past experiences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Designing a Co-created Intervention to Promote Motivation and Maintenance of Time-Restricted Eating in Individuals With Overweight and Type 2 Diabetes. Hempler, NF., Bjerre, N., Varming, AR., et al.[2023]

A 12-week study involving participants with type 2 diabetes on insulin therapy aims to compare the effects of intermittent fasting against standard care, focusing on changes in HbA1c levels and overall health outcomes.

The study will assess key outcomes such as HbA1c reduction and the percentage of participants achieving significant weight loss and insulin dose reduction, providing insights into the efficacy of intermittent fasting as an alternative dietary intervention for diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

INTERmittent FASTing in people with insulin-treated type 2 diabetes mellitus - the INTERFAST-2 study protocol. Obermayer, A., Tripolt, NJ., Pferschy, PN., et al.[2023]

Intermittent fasting (IF) and continuous energy-restricted diets (CERD) showed similar effects on glycemic control in patients with type 2 diabetes and metabolic syndrome, based on a meta-analysis of four studies with 355 participants.

However, IF resulted in greater weight loss compared to CERD, indicating it may be a beneficial dietary approach for overweight or obese patients with these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Wang, X., Li, Q., Liu, Y., et al.[2021]

Intermittent fasting (IF) showed similar reductions in HbA1C and BMI compared to continuous energy restriction in individuals with Type 2 Diabetes Mellitus, but these differences were not statistically significant.

The review highlights the need for more extensive research on IF as a treatment for T2DM, as current evidence is insufficient to influence clinical guidelines despite its potential benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Review of Intermittent Fasting as a Treatment for Type 2 Diabetes Mellitus. Silver, DT., Pekari, TB.[2023]

Intermittent fasting (IF) shows promise in improving glucose control and potentially reversing some effects of type 2 diabetes, with animal studies indicating enhanced β cell function and insulin resistance independent of weight loss.

In humans, IF is associated with weight loss and improvements in glucose and insulin levels, with no increased risk of hypoglycemia reported, suggesting it could be a safe dietary approach for managing type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intermittent Fasting as Part of the Management for T2DM: from Animal Models to Human Clinical Studies. Muñoz-Hernández, L., Márquez-López, Z., Mehta, R., et al.[2020]

Time-restricted eating (TRE) appears to be safe for individuals with type 2 diabetes, based on four completed studies and 14 ongoing studies, provided that their antidiabetic medications are monitored and adjusted accordingly.

Despite the promising safety profile of TRE, the limited number of studies and their low generalizability highlight the need for further research to establish clear recommendations for its efficacy and safety in managing type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is Time-Restricted Eating Safe in the Treatment of Type 2 Diabetes?-A Review of Intervention Studies. Uldal, S., Clemmensen, KKB., Persson, F., et al.[2022]

Intermittent fasting (IF) may be an effective weight management strategy for overweight and obese adults, but its evidence base in humans is still limited, with only one published systematic review available.

Current guidelines from the National Institute for Health and Care Excellence (NICE) do not recommend very low calorie diets (VLCD) as a routine treatment for obesity, highlighting concerns about potential side effects and the sustainability of fasting approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intermittent fasting interventions for the treatment of overweight and obesity in adults aged 18 years and over: a systematic review protocol. Jane, L., Atkinson, G., Jaime, V., et al.[2022]

In an 8-week study with 59 obese participants, alternate day fasting (ADF) led to a significant weight loss of 4.2%, while only a small percentage reported mild adverse effects like constipation and dizziness.

ADF was associated with improvements in eating disorder symptoms, including a decrease in depression and binge eating, suggesting that it may have beneficial effects on body image and eating behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of alternate day fasting and effect on disordered eating behaviors. Hoddy, KK., Kroeger, CM., Trepanowski, JF., et al.[2018]

A 4-week time-restricted eating (TRE) intervention was found to be feasible for individuals with type 2 diabetes, with participants adhering to the eating window about 72% of the time, which helped reduce daily energy intake.

Despite the feasibility of TRE, it did not significantly improve glycaemic control or body mass in participants, indicating that while it may help with dietary management, it may not lead to substantial health improvements in blood sugar levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time-Restricted Eating as a Nutrition Strategy for Individuals with Type 2 Diabetes: A Feasibility Study. Parr, EB., Devlin, BL., Lim, KHC., et al.[2022]

In a 6-month randomized clinical trial with 75 participants who had type 2 diabetes, time-restricted eating (TRE) led to a significant weight loss of 3.56% compared to controls, while daily calorie restriction (CR) did not show a significant difference in weight loss.

Both TRE and CR resulted in similar reductions in hemoglobin A1c (HbA1c) levels, indicating that TRE can be an effective dietary strategy for improving glycemic control without the need for calorie counting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Time-Restricted Eating on Weight Loss in Adults With Type 2 Diabetes: A Randomized Clinical Trial. Pavlou, V., Cienfuegos, S., Lin, S., et al.[2023]

Time-restricted eating (TRE) is a feasible and safe intervention for individuals with overweight, obesity, prediabetes, or type 2 diabetes, with high retention rates of 95% for studies under 12 weeks and 89% for those 12 weeks or longer.

Participants generally adhered to TRE well, with median adherence rates of 89% for shorter studies and 81% for longer ones, although individual experiences varied, highlighting the need for support and flexibility in the approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of time-restricted eating in individuals with overweight, obesity, prediabetes, or type 2 diabetes: A systematic scoping review. Termannsen, AD., Varming, A., van Elst, C., et al.[2023]

In a pilot study involving 20 adults with overweight or obesity, time-restricted eating (TRE) for 12 weeks did not significantly improve insulin sensitivity, insulin secretion, or β-cell function compared to unrestricted eating.

The results suggest that while TRE is a popular dietary approach, it may not be effective for enhancing metabolic parameters in individuals without diabetes, indicating a need for further research in those with prediabetes or type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time-restricted eating did not alter insulin sensitivity or β-cell function in adults with obesity: A randomized pilot study. Bantle, AE., Lau, KJ., Wang, Q., et al.[2023]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Designing a Co-created Intervention to Promote Motivation and Maintenance of Time-Restricted Eating in Individuals With Overweight and Type 2 Diabetes. [2023]

2. England pubmed.ncbi.nlm.nih.gov

INTERmittent FASTing in people with insulin-treated type 2 diabetes mellitus - the INTERFAST-2 study protocol. [2023]

3. Ireland pubmed.ncbi.nlm.nih.gov

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]

4. United States pubmed.ncbi.nlm.nih.gov

A Review of Intermittent Fasting as a Treatment for Type 2 Diabetes Mellitus. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Intermittent Fasting as Part of the Management for T2DM: from Animal Models to Human Clinical Studies. [2020]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Is Time-Restricted Eating Safe in the Treatment of Type 2 Diabetes?-A Review of Intervention Studies. [2022]

7. Australia pubmed.ncbi.nlm.nih.gov

Intermittent fasting interventions for the treatment of overweight and obesity in adults aged 18 years and over: a systematic review protocol. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Safety of alternate day fasting and effect on disordered eating behaviors. [2018]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Time-Restricted Eating as a Nutrition Strategy for Individuals with Type 2 Diabetes: A Feasibility Study. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Effect of Time-Restricted Eating on Weight Loss in Adults With Type 2 Diabetes: A Randomized Clinical Trial. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Feasibility of time-restricted eating in individuals with overweight, obesity, prediabetes, or type 2 diabetes: A systematic scoping review. [2023]

12. United States pubmed.ncbi.nlm.nih.gov

Time-restricted eating did not alter insulin sensitivity or β-cell function in adults with obesity: A randomized pilot study. [2023]