Intermittent Fasting for Type 1 Diabetes

Overseen By Krista Varady, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Illinois at Chicago

Must be taking: Insulin, Glucagon

Disqualifiers: T2DM, Eating disorders, Pregnancy, others

Stay on Your Current Meds You can continue your current medications while participating

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The majority of adults with type 1 diabetes (T1DM) have either overweight or obesity. As such, dietary management has been recommended as an adjunct to insulin treatment to improve glycemic control and facilitate weight loss in patients with T1DM. Daily calorie restriction (CR) is the main diet prescribed to patients with T1DM for weight loss. However, many patients find it difficult to adhere to CR because calorie intake must be vigilantly monitored every day. In light of these problems with CR, another approach that limits timing of food intake, instead of number of calories consumed, has been developed. This diet is called "time restricted eating" (TRE) and involves confining the period of food intake to 6-8 h per day. TRE allows individuals to self-select foods and eat ad libitum during a large part of the day, which greatly increases compliance to these protocols. The simplicity of TRE, its accommodation of dietary preferences, and associated weight loss may translate to improved glycemic measures in patients with T1DM. The present study will be the first randomized controlled trial to compare the effect of TRE versus CR for weight management and improved glycemic control in adults with obesity and T1DM.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, since it involves dietary changes and you must be on insulin, it's likely you'll continue your current insulin regimen. It's best to discuss with the trial coordinators or your doctor.

Is intermittent fasting safe for people with type 1 diabetes?

Research on intermittent fasting in people with type 1 diabetes is limited, but a study on a 24-hour fast at home found it to be feasible and safe. Other studies on time-restricted eating in different groups, like those with obesity or at risk of type 2 diabetes, suggest it is generally safe, with mild side effects like fatigue, constipation, and headache. ^{1 2 3 4 5}

How does intermittent fasting differ from other treatments for type 1 diabetes?

Intermittent fasting is unique because it involves eating only during specific hours and fasting for the rest of the day, which is different from traditional treatments that focus on continuous calorie restriction. This approach may improve glucose metabolism by incorporating meal timing with prolonged fasting, offering a novel way to manage blood sugar levels. ^{5 6 7 8 9}

What data supports the effectiveness of the treatment Intermittent Fasting for Type 1 Diabetes?

Research shows that intermittent fasting can improve glucose metabolism in people at risk of type 2 diabetes, suggesting it might help manage blood sugar levels. However, more research is needed to confirm its effectiveness specifically for type 1 diabetes. ^{4 5 6 9 10}

Who Is on the Research Team?

Krista Varady, PhD

Principal Investigator

University of Illinois Chicago

Are You a Good Fit for This Trial?

Adults aged 18-75 with Type 1 Diabetes, a BMI of 25-50, and HbA1c levels between 6.5-9.5% are eligible for this trial if they're on insulin treatment and have been weight stable for the past three months. It's not suitable for those with eating disorders, pregnant women, night shift workers, or individuals with certain severe medical conditions.

Inclusion Criteria

I use insulin multiple times a day or have an insulin pump.

I have type 1 diabetes and am using insulin.

Your HbA1c level is between 6.5% and 9.5% regardless of the medications you're taking.

Exclusion Criteria

Pregnant, or trying to become pregnant

People who work at night are not eligible.

I do not have heart failure, severe lung, liver, kidney diseases, active cancer, or a history of stroke.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are assigned to either time restricted eating (TRE) or daily calorie restriction (CR) for weight management and glycemic control

6 months

Monthly visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Daily calorie restriction
• Time restricted eating

Trial Overview The study is testing two dietary approaches to manage weight and improve blood sugar control in adults with obesity and Type 1 Diabetes: Time Restricted Eating (TRE), which limits food intake to a specific time window each day versus Daily Calorie Restriction (CR), where calorie intake is monitored daily.

How Is the Trial Designed?

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

8-h eating window Ad libitum food intake from 12-8 pm every day Fasting from 8-12 pm every day (16-h fast)

Group II: Daily calorie restriction (CR) Experimental Treatment 1 Intervention

25% energy restriction every day Diet counseling provided

Group III: Control Active Control 1 Intervention

Ad libitum food intake, eating over more than 10 hours per day

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials

653

Recruited

1,574,000+

Published Research Related to This Trial

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) and continuous energy-restricted diets (CERD) showed similar effects on glycemic control in patients with type 2 diabetes and metabolic syndrome, based on a meta-analysis of four studies with 355 participants.

However, IF resulted in greater weight loss compared to CERD, indicating it may be a beneficial dietary approach for overweight or obese patients with these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intermittent fasting versus continuous energy-restricted diet for patients with type 2 diabetes mellitus and metabolic syndrome for glycemic control: A systematic review and meta-analysis of randomized controlled trials. Wang, X., Li, Q., Liu, Y., et al.[2021]

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 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]

Intermittent fasting (IF) showed similar reductions in HbA1C and BMI compared to continuous energy restriction in individuals with Type 2 Diabetes Mellitus, but these differences were not statistically significant.

The review highlights the need for more extensive research on IF as a treatment for T2DM, as current evidence is insufficient to influence clinical guidelines despite its potential benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Review of Intermittent Fasting as a Treatment for Type 2 Diabetes Mellitus. Silver, DT., Pekari, TB.[2023]

Citations

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

Time of Day When Type 1 Diabetes Patients With Eating Disorder Symptoms Most Commonly Restrict Insulin. [2022]

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. Ireland pubmed.ncbi.nlm.nih.gov

Intermittent fasting versus continuous energy-restricted diet for patients with type 2 diabetes mellitus and metabolic syndrome for glycemic control: A systematic review and meta-analysis of randomized controlled trials. [2021]

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

Intermittent fasting vs daily calorie restriction for type 2 diabetes prevention: a review of human findings. [2022]

5. Turkey pubmed.ncbi.nlm.nih.gov

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

6. England pubmed.ncbi.nlm.nih.gov

Type 1 diabetes and prolonged fasting. [2011]

7. France pubmed.ncbi.nlm.nih.gov

Ambulatory 24-hour fast using flexible insulin therapy in patients with type 1 diabetes. [2022]

8. Canada pubmed.ncbi.nlm.nih.gov

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

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

A Review of Intermittent Fasting as a Treatment for Type 2 Diabetes Mellitus. [2023]

10. Ireland pubmed.ncbi.nlm.nih.gov

The effect of intermittent compared with continuous energy restriction on glycaemic control in patients with type 2 diabetes: 24-month follow-up of a randomised noninferiority trial. [2019]