Time Restricted Feeding for Type 2 Diabetes

Overseen By Lynn M Petrik, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: OhioHealth

Must be taking: Antidiabetics

Disqualifiers: Pregnancy, Thyroid dysfunction, Renal failure, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether eating only during certain hours of the day (time-restricted feeding) can help individuals with poorly controlled Type 2 diabetes manage their blood sugar more effectively. Participants will eat freely for one week, then switch to eating only between 4 AM and 4 PM for another week, before returning to their usual eating schedule. The researchers aim to determine if this eating pattern can improve blood sugar levels without altering medication doses. The trial seeks OhioHealth patients who have had Type 2 diabetes with high blood sugar levels (A1c of 8.0 or more) and have been on the same diabetes medication for the last three months. As an unphased trial, this study offers a unique opportunity to explore innovative dietary approaches to improve diabetes management.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants should have been on stable antidiabetics for the 3 months before enrollment, suggesting you may continue your current diabetes medications.

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

Research has shown that time-restricted eating (TRE) is generally safe for people with type 2 diabetes. Studies indicate that TRE can aid in weight loss and improve blood sugar control. For instance, one study found that adults with type 2 diabetes lost more weight using TRE compared to other methods. Another study demonstrated that TRE helped lower blood pressure and improved the body's sugar management. Importantly, TRE is considered a safe and manageable way to help control diabetes and may even benefit heart health. Overall, TRE appears to be well-tolerated with few reported issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about time-restricted feeding for type 2 diabetes because it offers a unique approach by focusing on when you eat, rather than what you eat. Unlike standard treatments that often involve medication or calorie counting, time-restricted feeding aligns eating patterns with the body's natural circadian rhythms, potentially improving blood sugar control. This method could simplify diabetes management by reducing the need for constant monitoring and dietary adjustments, making it an attractive alternative for both patients and healthcare providers.

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

Research shows that time-restricted eating (TRE), which participants will experience during the experimental phase of this trial, can benefit people with Type 2 Diabetes. Studies have found that TRE can lead to weight loss, with participants losing up to 3.6% of their body weight. This method also reduces HbA1c levels, a measure of long-term blood sugar control. Specifically, one study found that following a TRE plan for 12 weeks helped maintain more stable blood sugar levels. These findings suggest that TRE could be a promising way to better manage Type 2 Diabetes. ^{2 3 4 6 7}

Who Is on the Research Team?

Yuanjie Mao, MD, PhD

Principal Investigator

OhioHealth

Are You a Good Fit for This Trial?

This trial is for adults aged 18-64 with poorly controlled Type 2 diabetes, an A1c level of at least 8.0, and stable on diabetic medications for the past three months. It's not suitable for those with severe hypoglycemia history, advanced organ failure, significant mental impairments, thyroid issues in the last six months, current participation in another study or non-adherence to treatments.

Inclusion Criteria

OhioHealth Patient

Your A1c level is higher than 8.0 in the last 3 months.

I have been diagnosed with type 2 diabetes.

Exclusion Criteria

I have had thyroid issues in the last 6 months.

I do not have an active infection or another type of cancer.

I am unable to understand and agree to the study's procedures and risks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Ad libitum feeding (Control Phase I)

Participants follow an ad libitum feeding schedule for one week as a control phase

1 week

Time-restricted feeding (Experimental Phase)

Participants follow a time-restricted feeding schedule (feeding between 4 AM - 4 PM) for one week

1 week

Ad libitum feeding (Control Phase II)

Participants return to an ad libitum feeding schedule for one week as a control phase

1 week

Follow-up

Participants are monitored for changes in mean glucose, serum triglyceride levels, insulin resistance, and body weight

2-4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Time restricted feeding

Trial Overview The study tests if Time-Restricted Feeding can improve blood sugar control in Type 2 diabetes patients using their current or lower doses of antidiabetic drugs over a period of three weeks.

How Is the Trial Designed?

Group I: Time restricted feeding Experimental Treatment 1 Intervention

The study will consist of three phases. In phase I all study subjects will be in the ad libitum feeding phase for one week followed by Phase II. In Phase II the subjects will be placed on time-restricted fasting (feeding between 4 AM - 4 PM, fasting in the rest of the day) for one week. For phase III (final week), patients will be returned to an ad libitum feeding. The first and third phases will serve as control phases, and the second phase will be the experimental phase

Who Is Running the Clinical Trial?

OhioHealth

Lead Sponsor

Trials

31

Recruited

5,500+

Ohio University

Collaborator

Trials

73

Recruited

17,800+

Citations

1. 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.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37889487/

Effect of Time-Restricted Eating on Weight Loss in Adults With ... This randomized clinical trial found that a TRE diet strategy without calorie counting was effective for weight loss and lowering of HbA1c levels.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03940482

Time Restricted Eating As Treatment (TREAT) for Diabetes ... This 12-week study of TREAT in adult patients with Type 2 Diabetes Mellitus aims to explore if this simplified form of intermittent fasting can result in ...

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

Effects of time-restricted eating on glycemic control in type ... The 12-week TRE intervention not only significantly reduced body weight (−1.72 ± 1.83 kg, P < 0.001), but also remarkably improved glycemic control, with ...

5. thelancet.com thelancet.com/journals/lanhl/article/PIIS2666-7568(24)00028-X/fulltext

Effects of 3 months of 10-h per-day time-restricted eating ... Since 2015, several small studies have reported weight loss of approximately 1–4% and improvements in glucose regulation, blood lipid profile, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9182892/

Is Time-Restricted Eating Safe in the Treatment of Type 2 ... Recent studies have shown that TRE can lead to weight loss and improvement of insulin sensitivity and glucose tolerance in people with overweight and high risk ...

7. 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.