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

Trial Summary

What is the purpose of this trial?

The purpose of this study is to test whether eating earlier in the day and/or timed light therapy can improve blood sugar in people with type 2 diabetes. This study will also test whether these treatments improve other aspects of health, including the circadian (biological) clock, sleep, weight, body composition, cardiovascular health, quality of life, and mood.

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 data supports the effectiveness of the treatment Time-Restricted Feeding + Light Therapy for Type 2 Diabetes?

Research shows that time-restricted feeding (TRF) can improve blood glucose control and insulin sensitivity in people with type 2 diabetes. Additionally, TRF has been positively perceived by participants and may help reduce the risk of chronic diseases by aligning eating patterns with natural circadian rhythms. ^{1 2 3 4 5}

Is time-restricted feeding safe for humans?

Time-restricted feeding (TRE) has been studied in humans and is generally considered safe, with benefits like weight loss and improved blood sugar control. However, more research is needed to fully understand its long-term safety. ^{2 3 6 7 8}

How is the treatment of Time-Restricted Feeding and Light Therapy unique for type 2 diabetes?

This treatment is unique because it combines time-restricted eating (a form of intermittent fasting) with light therapy to potentially improve blood sugar control and insulin sensitivity in people with type 2 diabetes. Unlike traditional treatments that often involve medication, this approach focuses on lifestyle changes to align eating patterns and light exposure with the body's natural circadian rhythms. ^{1 2 7 9 10}

Research Team

Courtney Peterson, Ph.D.

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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), 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]

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 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]

References

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

Time-restricted feeding improves blood glucose and insulin sensitivity in overweight patients with type 2 diabetes: a randomised controlled trial. [2021]

3. Germany pubmed.ncbi.nlm.nih.gov

Early time-restricted carbohydrate consumption vs conventional dieting in type 2 diabetes: a randomised controlled trial. [2023]

4. Switzerland 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. [2020]

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

Time-restricted Eating for the Prevention and Management of Metabolic Diseases. [2022]

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

Randomized controlled trial for time-restricted eating in overweight and obese young adults. [2022]

7. 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]

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

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

9. Ireland pubmed.ncbi.nlm.nih.gov

Time-restricted eating improves measures of daily glycaemic control in people with type 2 diabetes. [2023]

10. 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]