Intermittent Fasting for Type 2 Diabetes

Overseen By Annie Eller, RD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Kansas Medical Center

Must not be taking: Hypoglycemia-inducing medications

Disqualifiers: Cancer, Hypertension, Cardiac event, others

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

Compensation: Varies

Number of Visits: 24

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether two types of intermittent fasting can help people with type 2 diabetes manage their blood sugar better and possibly reverse the condition. One group will eat only during an 8-hour window each day, known as Time Restricted Eating (TRE). The other group will follow a very low-calorie diet for 2-3 days a week, referred to as Intermittent Energy Restriction (IER). The trial seeks participants who have had type 2 diabetes for less than 10 years, struggle with weight, and can join a physical activity program. 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?

If you are currently taking medications that could cause low blood sugar during fasting and are unwilling to stop them before the study, you may not be eligible to participate.

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

Research shows that both intermittent energy restriction (IER) and time-restricted eating (TRE) are safe for people with type 2 diabetes. Studies indicate that IER can help improve blood sugar control and is generally well-tolerated, even for those using diet or medication to manage their diabetes. Similarly, TRE is considered safe and may offer additional benefits like better heart health and improved blood sugar levels. In a study with 75 adults, TRE led to noticeable weight loss and better blood sugar control over 12 weeks. Both methods are regarded as safe ways to potentially manage type 2 diabetes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about intermittent fasting methods like Intermittent Energy Restriction (IER) and Time-Restricted Eating (TRE) for managing Type 2 Diabetes because they offer a novel approach compared to standard treatments like medications and lifestyle changes. Unlike traditional methods that often focus on consistent calorie reduction, IER involves eating a very-low energy diet only a few days a week, which might be easier for some people to maintain. TRE, on the other hand, limits eating to an 8-hour window each day, potentially aligning better with natural body rhythms and improving metabolic health. These methods could offer more flexible lifestyle options that might improve adherence and outcomes for patients with Type 2 Diabetes.

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

This trial will compare Time Restricted Eating (TRE) and Intermittent Energy Restriction (IER) for managing type 2 diabetes. Research has shown that both methods can help people with type 2 diabetes manage their blood sugar levels. Participants in the TRE arm will follow an intermittent fasting schedule with an 8-hour eating period, which significantly lowers fasting blood sugar and leads to weight loss. One study found that people practicing TRE lost 3.6% of their body weight over six months, aiding in better diabetes management. Meanwhile, participants in the IER arm will follow a very-low energy diet (550-800 kcal/d) 2-3 days per week. IER has been shown to reduce HbA1c levels, an important measure of long-term blood sugar control, and some studies suggest it can improve blood sugar regulation in the short term. Both methods seem to help with diabetes management, but the benefits might differ for each person. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for adults aged 21-65 with type 2 diabetes diagnosed within the last decade, having a BMI of 25-45 and an HbA1c level between 6.7-9.5%. Participants should be able to exercise and get clearance from the study physician. Those pregnant, lactating, on certain medications, or with recent serious medical issues can't join.

Inclusion Criteria

You can take part in a program that gradually increases physical activity.

I was diagnosed with type 2 diabetes within the last 10 years.

My HbA1c level is between 6.7-9.5%, or it's below 6.7% but I'm on medication to lower it.

Exclusion Criteria

I have a serious health condition that could make lifestyle changes risky.

I cannot attend health education meetings.

I am on medication that can lower my blood sugar and cannot stop it for the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Weight Loss Program

A 12-week weight loss program featuring weekly group meetings

12 weeks

12 visits (in-person)

Weight Maintenance Program

A 12-week weight maintenance program featuring biweekly group meetings

12 weeks

6 visits (in-person)

Low-contact Follow-up

A 6-month low-contact follow-up period featuring monthly check-ins

24 weeks

6 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Intermittent energy restriction (IER)
• Time Restricted Eating (TRE)

Trial Overview The trial is examining if intermittent fasting—either Intermittent Energy Restriction (IER) or Time Restricted Eating (TRE)—can help control blood sugar levels in type 2 diabetes patients and possibly lead to remission of the disease.

How Is the Trial Designed?

Group I: Time-restricted eating (TRE) Experimental Treatment 1 Intervention

Intermittent fasting using an 8-hour eating period.

Group II: Intermittent energy restriction (IER) Experimental Treatment 1 Intervention

Intermittent fasting using a very-low energy diet (VLED; 550-800 kcal/d) 2-3 days per week

Who Is Running the Clinical Trial?

University of Kansas Medical Center

Lead Sponsor

Trials

527

Recruited

181,000+

American Diabetes Association

Collaborator

Trials

148

Recruited

102,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Published Research Related to This Trial

Intermittent fasting (IF) shows promise in improving glucose control and potentially reversing some effects of type 2 diabetes, with animal studies indicating enhanced β cell function and insulin resistance independent of weight loss.

In humans, IF is associated with weight loss and improvements in glucose and insulin levels, with no increased risk of hypoglycemia reported, suggesting it could be a safe dietary approach for managing type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intermittent Fasting as Part of the Management for T2DM: from Animal Models to Human Clinical Studies. Muñoz-Hernández, L., Márquez-López, Z., Mehta, R., et al.[2020]

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]

Time-restricted eating (TRE), which limits food intake to 6 to 10 hours during the active part of the day, has been shown to improve metabolic health and glucose tolerance in various models, including humans.

Most research on TRE has focused on starting the eating window in the morning, but this paper highlights potential challenges and metabolic effects of delaying the eating window, suggesting that timing may be crucial for maximizing benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Will Delaying Breakfast Mitigate the Metabolic Health Benefits of Time-Restricted Eating? Heilbronn, LK., Regmi, P.[2021]

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 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]

Time-restricted eating (TRE) can lead to a weight loss of 1-4% over 1-16 weeks in individuals with obesity, primarily due to unintentional reductions in daily calorie intake of about 350-500 kcal.

TRE is effective in improving cardiovascular health by lowering fat mass, blood pressure, triglyceride levels, and markers of oxidative stress, and it is considered safe with few adverse events reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time-Restricted Eating to Improve Cardiovascular Health. Gabel, K., Cienfuegos, S., Kalam, F., et al.[2021]

Citations

1. endocrine.org endocrine.org/news-and-advocacy/news-room/endo-annual-meeting/endo-2025-press-releases/zhang-press-release

Intermittent energy restriction may improve outcomes in ... At the end of the study, there were no significant differences in HbA1c reduction and weight loss between the IER, TRE and CER groups. However, ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10494137/

Metabolic impact of intermittent energy restriction and periodic ... The results of this systematic review suggest that IER and PF can improve glucose regulation in patients with T2D, at least in the short term.

3. sciencedirect.com sciencedirect.com/science/article/pii/S2666970624000532

Efficacy and safety of intermittent fasting for type 2 diabetes ... Studies show intermittent fasting (IF) can effectively lower glycated haemoglobin (HbA1c) levels and reduce weight and levels in individuals with type 2 ...

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2820237

A 5:2 Intermittent Fasting Meal Replacement Diet and ... In this randomized clinical trial of 405 adults, the 5:2 MR approach achieved better glycemic control at 16 weeks compared with metformin and empagliflozin.

5. diabetesjournals.org diabetesjournals.org/care/article/47/6/1074/154508/Effect-of-5-2-Regimens-Energy-Restricted-Diet-or

Effect of 5:2 Regimens: Energy-Restricted Diet or Low-Volume ... Daily calorie restriction leading to substantial weight loss has been proven to improve glycemic control and induce diabetes remission (2,3).

6. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2688344

Effect of Intermittent Compared With Continuous Energy ... Intermittent energy restriction is safe for people who have either diet-controlled type 2 diabetes or are using medication that is not likely to ...

7. diabetesjournals.org diabetesjournals.org/care/article/46/2/463/148123/Efficacy-and-Safety-of-Intermittent-Fasting-in

Efficacy and Safety of Intermittent Fasting in People With ... We hypothesized that 12 weeks of IF could improve glycemic control and decrease body weight while being safe to practice in people with insulin- ...