Time Restricted Eating for Type 2 Diabetes

(SFS3 Trial)

Overseen By Brad Yentzer or Abdisa Taddese

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Minnesota

Must be taking: Metformin

Must not be taking: Other diabetes medications

Disqualifiers: Pregnancy, Eating disorders, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

60 Participants Needed

Trial Summary

What is the purpose of this trial?

Hyperglycemia in patients with Type 2 Diabetes Mellitus is initially treated with metformin coupled with intentional caloric restriction, which is difficult to sustain due to multiple barriers, including acquiring the necessary knowledge, teaching the intervention, cost of delivery and potential burden on quality of life. In contrast to intentionally restricting calories, time restricted eating (TRE), presents a simplified view of eating focused on restricting the eating window, which allows ad libitum intake per a person's dietary preferences during a daily fixed eating window. This study proposes a 24 week feasibility study to test if TRE is a viable alternative to Caloric Restriction in improving glycemic measures while accounting for weight loss in overweight/obese patients \[BMI:25-45 kg/m2\] with metformin-only treated Type 2 diabetes.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it requires that participants are only treated with metformin for their type 2 diabetes.

What data supports the effectiveness of the treatment Time Restricted Eating for Type 2 Diabetes?

Research shows that time-restricted eating can improve blood sugar control and insulin sensitivity in people with type 2 diabetes. Studies also suggest that this approach can lead to better glucose tolerance compared to standard calorie restriction, although some benefits may diminish over time. ^{1 2 3 4 5}

Is time-restricted eating safe for humans?

Research suggests that time-restricted eating, which involves eating within a specific time window each day, is generally safe for humans. Studies have shown that it can be safely practiced by adults with obesity and those at risk of type 2 diabetes, with only mild and temporary side effects like fatigue, constipation, and headache reported. ^{1 2 5 6 7}

How is time-restricted eating different from other treatments for type 2 diabetes?

Time-restricted eating is unique because it focuses on limiting the hours during which food is consumed each day, rather than just reducing calorie intake. This approach can improve blood sugar control and insulin sensitivity by aligning eating patterns with the body's natural circadian rhythms, which is different from traditional calorie restriction or medication-based treatments. ^{1 2 5 8 9}

Research Team

Lisa Chow, MD

Principal Investigator

University of Minnesota- Division of Endocrinology, Diabetes, and Metabolism

Eligibility Criteria

This trial is for adults aged 18-65 with Type 2 diabetes treated only with metformin, having a BMI of 25-40 and stable weight. Participants should have an HbA1c level between 6.5-8.5% and own a smartphone. Pregnant individuals, those on other diabetes medications besides metformin, or with eating disorders cannot join.

Inclusion Criteria

Self-reported weight must be stable [±5 pounds] for at least 3 months prior to the study

Your HbA1c level is between 6.5% and 8.5%.

I am overweight and have type 2 diabetes treated only with metformin.

Exclusion Criteria

Active or anticipated pregnancy during the study

I am being treated for Type 2 diabetes with medication other than metformin.

You have an eating disorder, as indicated by a survey.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 24-week feasibility study to test time restricted eating (TRE) as an alternative to caloric restriction

24 weeks

Regular visits for monitoring and data collection

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Caloric reduction
• Time restricted eating

Trial Overview The study is testing if time restricted eating (TRE), where participants eat during a fixed daily window without calorie counting, can improve blood sugar levels compared to traditional caloric restriction over a period of 24 weeks in overweight/obese patients.

Participant Groups

Group I: Time restricted eating Experimental Treatment 1 Intervention

daily 8 hour eating window

Group II: Caloric Restriction Active Control 1 Intervention

reduction of caloric intake by 15%

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Findings from Research

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]

A novel intermittent fasting approach called iTRE, which involves eating during a specific time window, showed greater improvements in glucose tolerance compared to traditional calorie restriction (CR) after 6 months in a study of 209 adults at risk for type 2 diabetes.

While iTRE led to better glucose metabolism initially, these benefits diminished by the 18-month follow-up, and participants reported more fatigue and some mild adverse effects compared to those on CR or standard care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intermittent fasting plus early time-restricted eating versus calorie restriction and standard care in adults at risk of type 2 diabetes: a randomized controlled trial. Teong, XT., Liu, K., Vincent, AD., et al.[2023]

Intermittent fasting (IF) shows potential benefits for diabetic patients, with evidence suggesting that its positive effects may outweigh the risks, based on various studies including animal research and small clinical trials.

However, there is currently insufficient high-quality evidence to recommend IF as a standard treatment for diabetes, highlighting the need for more rigorous long-term studies to determine the safest and most effective IF regimens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence-based information about intermittent fasting in diabetes patients: useful or harmful? Altay, M.[2023]

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]

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 23 obese adults, time-restricted feeding (TRF) with an 8-hour eating window was found to be safe, as there were no significant changes in self-reported adverse events or disordered eating patterns.

The study suggests that TRF can effectively support weight loss in obese individuals without negatively impacting their health or body image perception.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of 8-h time restricted feeding in adults with obesity. Gabel, K., Hoddy, KK., Varady, KA.[2019]

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]

A 4-week time-restricted eating (TRE) intervention was found to be feasible for individuals with type 2 diabetes, with participants adhering to the eating window about 72% of the time, which helped reduce daily energy intake.

Despite the feasibility of TRE, it did not significantly improve glycaemic control or body mass in participants, indicating that while it may help with dietary management, it may not lead to substantial health improvements in blood sugar levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time-Restricted Eating as a Nutrition Strategy for Individuals with Type 2 Diabetes: A Feasibility Study. Parr, EB., Devlin, BL., Lim, KHC., et al.[2022]

In a 12-week study involving 14 adults with obesity, time-restricted feeding (8-hour eating window) led to a significant weight loss of about 2 kg, indicating potential efficacy for weight management.

Despite the weight loss, the study found no significant changes in the diversity or composition of the gut microbiome, suggesting that time-restricted feeding may not impact gut health in terms of microbial diversity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of time restricted feeding on the gut microbiome in adults with obesity: A pilot study. Gabel, K., Marcell, J., Cares, K., et al.[2022]

References

1. 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]

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

Intermittent fasting plus early time-restricted eating versus calorie restriction and standard care in adults at risk of type 2 diabetes: a randomized controlled trial. [2023]

3. Turkey pubmed.ncbi.nlm.nih.gov

Evidence-based information about intermittent fasting in diabetes patients: useful or harmful? [2023]

4. Ireland pubmed.ncbi.nlm.nih.gov

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

5. 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]

6. Canada pubmed.ncbi.nlm.nih.gov

Safety of 8-h time restricted feeding in adults with obesity. [2019]

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. Switzerland pubmed.ncbi.nlm.nih.gov

Time-Restricted Eating as a Nutrition Strategy for Individuals with Type 2 Diabetes: A Feasibility Study. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Effect of time restricted feeding on the gut microbiome in adults with obesity: A pilot study. [2022]