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

57 Participants Needed

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. Intermittent fasting may improve how the body uses insulin and lower blood sugar levels. Different types of intermittent fasting have been shown to reduce body weight and improve diabetes parameters such as fasting glucose and fasting insulin. The program includes different phases with varying levels of support over time.

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 intermittent fasting safe for humans?

Time-restricted eating (a form of intermittent fasting) has been shown to improve body weight, glucose tolerance, and cardiovascular health in humans, suggesting it is generally safe. However, most studies focus on metabolic benefits, and more research is needed to fully understand long-term safety. ^{1 2 3 4 5}

How is the treatment of intermittent fasting unique for type 2 diabetes?

Intermittent fasting, including time-restricted eating, is unique for type 2 diabetes as it focuses on limiting eating to specific times or days, which can help improve blood sugar control and weight management without the need for daily medication adjustments. ^{1 2 6 7 8}

What data supports the effectiveness of the treatment Intermittent Fasting for Type 2 Diabetes?

Research suggests that time-restricted eating (TRE), a form of intermittent fasting, can improve blood sugar control and help with weight management in people with type 2 diabetes. Additionally, intermittent fasting may improve glucose control and potentially reverse some diabetes-related issues. ^{1 2 6 8 9}

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

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]

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) 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]

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]

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]

Citations

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

Metabolic impact of intermittent energy restriction and periodic fasting in patients with type 2 diabetes: a systematic review. [2023]

3. 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]

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

Intermittent Fasting as Part of the Management for T2DM: from Animal Models to Human Clinical Studies. [2020]

5. Ireland pubmed.ncbi.nlm.nih.gov

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

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

Time-Restricted Eating to Improve Cardiovascular Health. [2021]

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

Will Delaying Breakfast Mitigate the Metabolic Health Benefits of Time-Restricted Eating? [2021]

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

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

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

Intermittent energy restriction in type 2 diabetes: A short discussion of medication management. [2022]