Time-Restricted Feeding + Light Therapy for Type 2 Diabetes

Overseen By Courtney M Peterson, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Must be taking: Metformin, DPP-IV inhibitors

Must not be taking: Insulin

Disqualifiers: Type 1 diabetes, Severe retinopathy, Cancer, others

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

Compensation: Varies

Number of Visits: 38

Duration: 16 weeks

344 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether eating earlier in the day (Early Time-Restricted Feeding) or using light therapy (Timed Light Therapy) can improve blood sugar levels in people with type 2 diabetes. Researchers aim to determine if these methods also benefit sleep, weight, heart health, and mood. Participants will either adjust their meal times, use light therapy, try both, or maintain their usual habits. Ideal candidates have type 2 diabetes, take specific diabetes medications, and follow a regular morning schedule. As an unphased trial, this study provides a unique opportunity to explore innovative lifestyle changes that could enhance overall health and well-being.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must be on a stable dose of certain diabetes medications like metformin, DPP-IV inhibitors, SGLT2 inhibitors, sulfonylureas, or GLP-1 receptor agonists for at least 6 weeks before joining. If you're on other diabetes medications, you may not be eligible.

What prior data suggests that these treatments are safe for people with type 2 diabetes?

Research has shown that eating within a set time each day, known as early time-restricted feeding, is safe for people with diabetes. It aids in weight loss and improves blood sugar levels. One study found that participants following this eating pattern lost more weight than those who did not. Additionally, it can lower blood pressure and enhance heart health.

Research on timed light therapy indicates it can improve sleep quality and help regulate the body's internal clock. This therapy involves exposure to light at specific times to manage sleep patterns. It has been used safely in people with type 2 diabetes to enhance their sleep and daily routines.

Studies have shown that both early time-restricted feeding and timed light therapy are well-tolerated, with no major safety concerns reported. These findings make them promising options for improving health in people with type 2 diabetes. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about this trial because it explores innovative approaches like early time-restricted feeding and timed light therapy for managing Type 2 diabetes. Unlike standard treatments that often rely on medications or insulin to regulate blood sugar, these methods focus on lifestyle changes to potentially improve metabolic health. Early time-restricted feeding involves eating within a specific window of time each day, which might help align the body's internal clock with natural circadian rhythms. Meanwhile, timed light therapy aims to enhance insulin sensitivity by using specific light exposure patterns. These approaches could offer non-invasive and holistic alternatives to traditional diabetes management, making them a promising area of study.

What evidence suggests that this trial's treatments could be effective for type 2 diabetes?

Research has shown that eating all meals within a set number of hours each day, known as early time-restricted feeding, can benefit people with type 2 diabetes. Studies have found that this approach can lead to weight loss and better control of blood sugar levels, while also helping the body use insulin more effectively. In this trial, some participants will follow early time-restricted feeding.

Others will receive timed light therapy, which research suggests can improve sleep quality and help regulate the body's internal clock, potentially benefiting those with type 2 diabetes. While the direct effect of light therapy on blood sugar remains unclear, it appears to support better sleep and daily rhythms.

Additionally, some participants will experience both early time-restricted feeding and timed light therapy together, which might offer a comprehensive way to manage diabetes by boosting metabolism and overall health. ^{1 2 3 6 7}

Who Is on the Research Team?

Courtney Peterson, Ph.D.

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

Adults aged 30-80 with type 2 diabetes, HbA1c levels between 7.0 - 10.0%, and waking up between 5-9 am can join this trial if they're on stable diabetes medication or none at all. Excluded are those with severe health issues like unstable heart or liver disease, major psychiatric conditions, outdoor activity over 1.5 hours/day, recent significant weight changes, or travel plans that disrupt time zones during the study.

Inclusion Criteria

I am between 30 and 80 years old.

I have been on the same diabetes medication for at least 6 months or am not taking any.

Your HbA1c levels have been steady for the last 6 months (within 0.7%).

Exclusion Criteria

I have type 1 diabetes or was diagnosed with diabetes before I turned 18.

I spend over 1.5 hours outside daily.

I haven't changed my chronic medication dose in the last 2 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants follow their assigned treatment of either no change, early TRF, timed light therapy, or both for 16 weeks

16 weeks

Baseline and post-intervention testing during a 38-hour inpatient stay

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 months

What Are the Treatments Tested in This Trial?

Interventions

• Early Time-Restricted Feeding
• No change in light exposure
• No change in meal timing
• Timed Light Therapy

Trial Overview The study is examining if eating earlier in the day combined with timed light therapy can better manage blood sugar in type 2 diabetics compared to no change in meal timing or light exposure. It will also assess effects on sleep, weight, body composition, cardiovascular health, quality of life and mood.

How Is the Trial Designed?

Group I: Timed Light Therapy Experimental Treatment 2 Interventions

Group II: Early Time-Restricted Feeding and Timed Light Therapy Experimental Treatment 2 Interventions

Group III: Early Time-Restricted Feeding Experimental Treatment 2 Interventions

Group IV: No change in eating or light exposure habits Active Control 2 Interventions

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Published Research Related to This Trial

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]

In a study involving overweight and obese young adults, both early time-restricted eating (eTRE) and late time-restricted eating (lTRE) resulted in similar weight loss after 8 weeks compared to a control group.

eTRE was more effective than lTRE in improving several metabolic health markers, including reducing systolic blood pressure, glucose levels, fasting insulin, insulin resistance, and thyroid axis activity, while lTRE only reduced leptin levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled trial for time-restricted eating in overweight and obese young adults. Zhang, LM., Liu, Z., Wang, JQ., et al.[2022]

A 4-week, 9-hour time-restricted eating (TRE) protocol significantly improved glycaemic control in 19 adults with type 2 diabetes, reducing mean 24-hour glucose concentrations and total area under the curve (AUC) without changing dietary intake or physical activity levels.

Participants experienced 10% more time in the target glucose range and 10% less time above the target range during the TRE period, indicating enhanced blood sugar management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time-restricted eating improves measures of daily glycaemic control in people with type 2 diabetes. Parr, EB., Steventon-Lorenzen, N., Johnston, R., et al.[2023]

In a 12-week study involving 120 overweight adults with type 2 diabetes, time-restricted feeding (10-hour eating window) significantly improved glycaemic control, as evidenced by a 1.54% reduction in HbA1c and a weight loss of nearly 3 kg compared to a control group.

Participants in the time-restricted feeding group also showed improved insulin sensitivity and reduced levels of triglycerides and cholesterol, suggesting additional cardiovascular benefits alongside better diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time-restricted feeding improves blood glucose and insulin sensitivity in overweight patients with type 2 diabetes: a randomised controlled trial. Che, T., Yan, C., Tian, D., et al.[2021]

In a study involving 11 sedentary men with overweight/obesity, time-restricted feeding (TRF) for 8 hours per day showed a tendency to lower total 24-hour glucose levels compared to extended feeding (EXF) for 15 hours, with significant improvements in nocturnal glucose control.

Participants reported positive attitudes towards TRF, noting improved well-being, although they identified challenges such as work schedules and social commitments that could hinder adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Delayed Morning and Earlier Evening Time-Restricted Feeding Protocol for Improving Glycemic Control and Dietary Adherence in Men with Overweight/Obesity: A Randomized Controlled Trial. Parr, EB., Devlin, BL., Radford, BE., et al.[2020]

Time-restricted eating (TRE) in humans, which involves consuming all calories within a consistent window of less than 12 hours, shows promise in reducing the risk of obesity, diabetes, and cardiovascular diseases, supported by both animal studies and pilot human interventions.

The approach is based on the understanding of circadian rhythms and their influence on metabolism, suggesting that maintaining a regular feeding schedule can help sustain these rhythms and potentially improve health outcomes, although further clinical studies are needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time-restricted Eating for the Prevention and Management of Metabolic Diseases. Manoogian, ENC., Chow, LS., Taub, PR., et al.[2022]

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]

The early time-restricted carbohydrate consumption (eTRC) diet was found to be a feasible and effective alternative for managing glucose levels and body weight in individuals with type 2 diabetes, with similar outcomes to a Mediterranean-style control diet over 12 weeks.

Both the eTRC and control diets resulted in comparable reductions in HbA1c and body weight, indicating that while eTRC is a viable dietary strategy, it does not provide additional metabolic benefits compared to conventional dieting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early time-restricted carbohydrate consumption vs conventional dieting in type 2 diabetes: a randomised controlled trial. Tricò, D., Masoni, MC., Baldi, S., et al.[2023]

Time-restricted eating (TRE), which limits calorie intake to 6- to 10-hour periods during the active part of the day, has been shown to improve various aspects of metabolic health, including weight loss, glucose tolerance, and cardiovascular health, based on both preclinical and human studies.

Implementing TRE can help mitigate the negative effects of eating out of sync with our body's natural circadian rhythms, potentially reducing the risk of chronic diseases, although there are challenges in applying this dietary approach in real-world settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time-Restricted Eating: Benefits, Mechanisms, and Challenges in Translation. Regmi, P., Heilbronn, LK.[2021]

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. 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.

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. 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, ...

5. nutritionandmetabolism.biomedcentral.com nutritionandmetabolism.biomedcentral.com/articles/10.1186/s12986-021-00613-9

Time-restricted feeding improves blood glucose and insulin ... Our study showed that 10-h TRF reduced body weight and blood glucose and improved insulin sensitivity in overweight patients with type 2 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11175017/

Effects of Early and Late Time-Restricted Feeding on ... As compared to controls, eTRF significantly decreased fasting glucose in two studies [30,34]. No significant effects were found for lTRF ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0168822724008039

Comparing the effects of time-restricted eating on ... Johnston, et al. Time-restricted eating improves measures of daily glycaemic control in people with type 2 diabetes. Diabetes Res Clin Pract, 110569 (2023) ...