Time-Restricted Eating for Type 2 Diabetes

(TEA-TIME Trial)

Overseen By Caroline K Kramer, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mount Sinai Hospital, Canada

Must be taking: Metformin, DPP-4 inhibitors, SGLT2 inhibitors

Must not be taking: Insulin, GLP-1 agonists, Sulfonylureas

Disqualifiers: Eating disorder, Renal dysfunction, Heart failure, Hepatic disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 52 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if time-restricted eating, which involves eating only between 2 PM and 8 PM daily, can improve blood sugar control in people with type 2 diabetes. The study compares this method to standard lifestyle recommendations to assess its effectiveness in preserving pancreatic function and managing diabetes. Ideal candidates have had type 2 diabetes for up to 10 years, maintained a consistent body weight recently, and are managing their diabetes without insulin. As an unphased trial, this study provides a unique opportunity to explore innovative lifestyle changes that could enhance diabetes management.

What prior data suggests that time-restricted eating is safe for individuals with type 2 diabetes?

Research has shown that time-restricted eating (TRE) is a safe option for people with type 2 diabetes. Studies indicate it can aid in weight loss, improve blood sugar control, and lower blood pressure. Importantly, TRE is considered a safe and practical approach for those with diabetes and prediabetes.

In one study, participants with type 2 diabetes who followed TRE for six months lost more weight than those who did not. While most studies highlight the benefits, they also emphasize TRE's safety in these situations.

Overall, TRE is not only effective but also easy for participants to follow. It does not involve taking medication, so the risk of side effects is generally lower compared to drug treatments. Consulting a healthcare provider is recommended to determine if TRE is suitable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about time-restricted eating for type 2 diabetes because it introduces a unique approach to managing blood sugar levels. Unlike standard treatments that often rely on medication to increase insulin sensitivity or lower glucose production, this method uses a simple eating schedule—an 18-hour fasting period with a 6-hour eating window. This approach could potentially help regulate metabolism and improve weight management without the need for additional drugs. By aligning eating habits with the body's natural circadian rhythms, this technique might offer a more holistic and sustainable way to manage diabetes.

What evidence suggests that time-restricted eating might be an effective treatment for type 2 diabetes?

This trial will compare time-restricted eating (TRE) with a standard lifestyle approach for managing type 2 diabetes. Research has shown that TRE can benefit people with type 2 diabetes. Studies have found that TRE significantly lowers fasting blood sugar levels, which is crucial for managing diabetes. In a six-month study, participants who followed TRE lost more weight than those using other methods, and their bodies handled sugar better. Observational studies, such as those conducted during Ramadan, have shown that fasting can improve blood sugar and cholesterol levels. This suggests that TRE might help protect the pancreas and enhance overall blood sugar control in people with diabetes. ^{1 3 4 5 6}

Are You a Good Fit for This Trial?

This trial is for individuals with type 2 diabetes, particularly those who are overweight. Participants should be interested in trying a time-restricted eating pattern as a potential treatment. Specific eligibility details aren't provided, but typically participants would need to meet certain health criteria and not have conditions that could interfere with the study.

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)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either time-restricted eating or standard lifestyle for 52 weeks

52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Time-restricted eating

Trial Overview The TEA TIME Trial is testing if not eating during set hours (time-restricted eating) can help people with type 2 diabetes control their blood sugar better and maintain pancreatic function compared to standard lifestyle advice.

How Is the Trial Designed?

Group I: Time-restricted eating Experimental Treatment 1 Intervention

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.

Group II: Standard lifestyle Active Control 1 Intervention

Standard lifestyle recommendation as per Diabetes Canada Guidelines.

Who Is Running the Clinical Trial?

Mount Sinai Hospital, Canada

Lead Sponsor

Trials

210

Recruited

70,700+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40806442/

Time-Restricted Eating Improves Glycemic Control in ... Meta-analyses of six eligible studies demonstrated that TRE significantly reduced fasting glucose (mean difference [MD]: -0.74 mmol/L; 95% CI: - ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S026156142500216X

Effects of time-restricted eating on glycemic control in type ... Human studies demonstrate that TRE helps to reduce body weight and fat mass, improve glucose tolerance and lower blood pressure in individuals with overweight ...

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2811116

Effect of Time-Restricted Eating on Weight Loss in Adults ... In a 6-month randomized clinical trial involving 75 adults with T2D, TRE was more effective for weight loss (−3.6%) than CR (−1.8%) compared with controls.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03940482

Time Restricted Eating As Treatment (TREAT) for Diabetes ... There is observational evidence from Ramadan studies of Diabetic patients that glycaemic control and lipid parameters improve over a 4-week fasting period. ...

5. clinicaltrials.ucsd.edu clinicaltrials.ucsd.edu/trial/NCT05365529

Time-Restricted Eating for Type II Diabetes: TRE-T2D This is a randomized clinical trial to assess the feasibility and efficacy of time-restricted eating (TRE) to improve glucose regulation and cardiovascular ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9671354/

Time-restricted eating for patients with diabetes and ... Time-restricted eating is a safe and feasible intervention, and may offer cardiovascular and metabolic benefits for patients with diabetes and prediabetes.