102 Participants Needed

Time-Restricted Eating for Type 2 Diabetes

MT
Overseen ByMatt Thomas, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether consuming all daily calories within a 10-hour window can help manage type 2 diabetes. The goal is to determine if this eating pattern, known as time-restricted eating, improves blood sugar control over a year. As a single-arm trial, all participants will follow the same eating schedule. Individuals with type 2 diabetes who are not pregnant, do not have an eating disorder, and are not night shift workers may be suitable for this study. As an unphased trial, it offers a unique opportunity to explore innovative approaches to managing type 2 diabetes.

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

Research has shown that time-restricted eating (TRE) is safe for people with type 2 diabetes. One study found that TRE not only proved safe but also offered heart and metabolism benefits for those with diabetes and prediabetes. Another study discovered that participants could easily follow TRE for 12 weeks without major safety issues.

Additionally, a 6-month study with adults who have type 2 diabetes demonstrated that TRE aided weight loss more effectively than other diet methods, again without safety concerns. In another study, following TRE for 12 weeks improved blood sugar control and led to weight loss in people with type 2 diabetes, and it was deemed safe.

These studies suggest that TRE is well-tolerated and does not cause significant side effects in people with type 2 diabetes.12345

Why are researchers excited about this trial?

Time-restricted eating is unique because it focuses on when you eat, not just what you eat, to help manage type 2 diabetes. Unlike standard treatments like medications that help control blood sugar, this approach involves consuming all daily calories within a 10-hour window each day. Researchers are excited because it might improve blood sugar control and promote weight loss without the need for additional medication. This method could offer a simpler, lifestyle-based way to tackle diabetes, potentially reducing the reliance on drugs and their associated side effects.

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

Research has shown that time-restricted eating (TRE), which participants in this trial will follow, can benefit people with type 2 diabetes. Studies have found that TRE lowers fasting blood sugar levels, aiding in blood sugar management. Participants in TRE studies have also lost more weight compared to those on regular diets. This method has been linked to better blood sugar control and lower blood pressure. Overall, TRE appears promising for improving health in those with type 2 diabetes.36789

Who Is on the Research Team?

MT

Matt Thomas, PhD

Principal Investigator

University of Kentucky

Are You a Good Fit for This Trial?

This trial is for individuals with type 2 diabetes who are patients at the University of Kentucky Barnstable Brown Diabetes Center. Specific eligibility criteria are not provided, but typically participants would need to meet certain health conditions and agree to follow the study procedures.

Inclusion Criteria

I have been diagnosed with Type 2 Diabetes.

Exclusion Criteria

Pregnant or breastfeeding
I have been diagnosed with an eating disorder.
I am taking medication that can lower my blood sugar.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a 10-hour time-restricted eating intervention for 1 year

1 year
Regular clinic visits for routine labs

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 intervention being studied is a time-restricted eating pattern where subjects eat only during a 10-hour window each day for one year. The aim is to see how this eating schedule affects their diabetes management.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Time-restricted eatingExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Justin (Matt) Thomas

Lead Sponsor

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: - ...

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 ...

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.

The Impact of Time Restricted Eating on Type 2 Diabetes

It has shown great promise as a novel intervention for stabilizing blood glucose, reducing weight, and improving cardiovascular disease outcomes. However, this ...

The impact of intermittent fasting during weight reduction in ...

A 12-hour intermittent fasting (IF) regimen combined with calorie restriction (CR) demonstrated superior efficacy in promoting weight loss and ...

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.

Time-Restricted Eating is a Feasible Dietary Strategy in the ...

We demonstrated that 12 weeks of TRE was feasible in individuals with overweight/obesity and type 2 diabetes in terms of easy recruitment and high retention and ...

Efficacy and Safety of Intermittent Fasting in People With ...

Our data demonstrate that IF over 12 weeks in insulin-treated people with type 2 diabetes is safe, reduces HbA1c, body weight, and total daily ...

Effects of time-restricted eating on glycemic control in type ...

In this single-center trial, we found that the 12-week TRE intervention not only significantly reduced body weight, but also improved the glycemic control, body ...