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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether time-restricted eating (TRE) can help manage blood sugar levels in people with Type 2 diabetes who take only metformin. Instead of counting calories, TRE involves eating all meals within an 8-hour window each day, allowing individuals to eat according to their usual preferences. The trial compares TRE to traditional calorie reduction (a weight loss diet) to determine which is more effective and easier to maintain. Suitable candidates for this trial include those with stable weight and Type 2 diabetes managed only with metformin, who are overweight or obese. As an unphased trial, this study provides a unique opportunity to explore innovative dietary approaches for improving 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, but it requires that participants are only treated with metformin for their type 2 diabetes.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that time-restricted eating (TRE) is generally safe for people with type 2 diabetes. TRE involves eating only during a specific part of the day. Studies have found that this method can aid in weight loss. One study revealed that adults with type 2 diabetes who ate within an 8-hour window lost more weight than those who only reduced calories, shedding about 4.5 kg over six months with TRE.

Although extensive safety data is still limited, current studies report no serious side effects. Some individuals might find TRE easier to maintain than daily calorie reduction. However, as this is a newer method, monitoring how the body responds and consulting a doctor if any issues arise is crucial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using time-restricted eating for type 2 diabetes because it focuses on when you eat, not just what you eat. This method allows for eating within an 8-hour window each day, which may help regulate blood sugar levels naturally and improve metabolic health without changing calorie intake. In contrast, caloric restriction, which is also being examined, involves reducing calorie intake by 15% and is already a common strategy for managing diabetes. The unique appeal of time-restricted eating lies in its potential to simplify meal planning and improve adherence, offering a promising alternative to existing treatments like medication or strict calorie counting.

What evidence suggests that this trial's treatments could be effective for Type 2 Diabetes?

Research has shown that time-restricted eating (TRE), one of the treatments in this trial, can help manage Type 2 diabetes. In one study, adults with Type 2 diabetes who followed TRE lost more weight than those who simply cut calories. Another study found that TRE helped lower HbA1c levels, a measure of blood sugar control. Additionally, eating within shorter time frames improved how the body uses insulin to manage blood sugar. Overall, TRE appears promising for better weight loss and improved blood sugar levels in people with Type 2 diabetes. Meanwhile, caloric restriction, another treatment arm in this trial, involves reducing caloric intake by 15% and serves as an active comparator to evaluate TRE's effectiveness. ^{2 3 6 7 8}

Who Is on the Research Team?

Lisa Chow, MD

Principal Investigator

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

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

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 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]

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 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]

Citations

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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.

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This randomized clinical trial found that a TRE diet strategy without calorie counting was effective for weight loss and lowering of HbA1c levels.

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sciencedirect.com

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Time-restricted eating: Watching the clock to treat obesity

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Either IF 16:8 or 14:10 had a benefit in the percentage weight change, glucose and lipid profiles in obese diabetic patients compared with the control group.

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sciencedirect.com

sciencedirect.com/science/article/pii/S026156142500216X

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Notably, another study conducted in patients with type 2 diabetes revealed more substantial weight loss (−4.52 kg, −4.28 %) following 6 months of 8-h TRE ...

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Intermittent fasting is the abstinence from food and caloric fluids over a specific period of time, followed by a period of food consumption (24, 37). According ...