Fasted Exercise for Type 1 Diabetes

(FED-T1D Trial)

Overseen By Reid McClure, MSc

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Alberta

Must be taking: Rapid insulin

Disqualifiers: Major complications, Uncontrolled hypertension, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare exercising before breakfast (fasted exercise) with exercising after breakfast (postprandial exercise) for people with type 1 diabetes. Over 12 weeks, participants will follow an exercise routine either before or after breakfast. The goal is to assess how these different timings affect diabetes management. Individuals who have had type 1 diabetes for at least 5 years, use an insulin pump, and manage their diabetes with a continuous glucose monitor (CGM) may be suitable candidates. As an unphased trial, this study provides a unique opportunity to contribute to understanding diabetes management through exercise timing.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it requires participants to use an insulin pump and rapid or ultra-rapid acting insulin analogs.

What prior data suggests that these exercise protocols are safe for people with type 1 diabetes?

Research has shown that exercising before breakfast, known as fasted exercise, is generally safe for people with type 1 diabetes. Studies have found that it can actually cause blood sugar levels to rise after exercising, rather than drop. This reduces the risk of low blood sugar (hypoglycemia) during or immediately after exercise.

Exercising after eating, called postprandial exercise, is also safe and effective. With proper precautions, such as adjusting insulin, it helps control blood sugar levels without causing harmful side effects.

In summary, both fasted and postprandial exercises are safe options. They each offer unique benefits and considerations, but overall, they are well-tolerated by people with type 1 diabetes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about fasted exercise for type 1 diabetes because it explores how timing of physical activity might impact blood sugar management. Typically, managing this condition involves insulin therapy and carbohydrate counting, but exercise timing is a less explored avenue. Fasted exercise, done before breakfast, might offer unique benefits by improving insulin sensitivity and stabilizing blood sugar levels without additional medication. On the other hand, postprandial exercise, performed after eating, could help manage post-meal blood sugar spikes. This trial aims to uncover how these different exercise timings can be optimized for better diabetes management.

What evidence suggests that this trial's exercise protocols could be effective for type 1 diabetes?

Research has shown that exercising before eating, known as fasted exercise, might help people with type 1 diabetes manage their weight and improve insulin use. Some participants in this trial will engage in fasted exercise. Studies have shown mixed results on blood sugar levels during fasted exercise; they might rise or fall.

Meanwhile, other participants will perform postprandial exercise, which involves exercising after eating. This type of exercise consistently lowers blood sugar levels, helping to prevent spikes after meals. Both types of exercise offer potential benefits, but they might work differently for each person. ^{2 3 6 7 8}

Who Is on the Research Team?

Normand G Boule, PhD

Principal Investigator

University of Alberta

Are You a Good Fit for This Trial?

This trial is for individuals with type 1 diabetes who are interested in how different timings of exercise might affect their condition. Specific eligibility details are not provided, but typically participants would need to be adults with a stable health status.

Inclusion Criteria

I use a CGM for my diabetes management.

HbA1c 7.0-9.9%

I have been diagnosed with type 1 diabetes for at least 5 years.

Exclusion Criteria

I haven't had a major health issue like a severe low blood sugar, diabetic coma, or heart problem in the last 3 months.

Ongoing pregnancy or breastfeeding

I am unable to understand and give consent for treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in aerobic exercise training either before breakfast (fasted) or after breakfast (fed) for 12 weeks

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Fasted Exercise
• Postprandial Exercise

Trial Overview The study is testing the effects of aerobic exercise before breakfast (fasted) versus after breakfast (postprandial) over a period of 12 weeks to see which timing might be more beneficial for people with type 1 diabetes.

How Is the Trial Designed?

Group I: Fasted Exercise Experimental Treatment 1 Intervention

Exercise training will be performed in the fasted state (i.e., before breakfast).

Group II: Postprandial Exercise Active Control 1 Intervention

Exercise will be performed in the postprandial period (i.e., after breakfast)

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Alberta Diabetes Institute

Collaborator

Trials

5

Recruited

130+

Published Research Related to This Trial

Anaerobic exercises, such as resistance training and high-intensity intervals, can help prevent drops in blood glucose levels during and after physical activity for individuals with type 1 diabetes.

The effectiveness of these exercises in managing blood glucose may differ based on factors like age, sex, and fitness level, highlighting the need for personalized approaches to exercise in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise strategies for hypoglycemia prevention in individuals with type 1 diabetes. Yardley, JE., Sigal, RJ.[2022]

In a study involving 10 adolescents with type 1 diabetes, moderate-intensity exercise performed at midday significantly increased the glucose infusion rate (GIR) needed to maintain normal blood sugar levels, indicating a heightened risk of hypoglycemia during and after exercise.

Unlike previous findings of a biphasic pattern of hypoglycemia risk after late-afternoon exercise, this study found that the risk of hypoglycemia remained elevated for several hours post-exercise without showing a second peak, suggesting different management strategies may be needed based on the timing of exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of midday moderate-intensity exercise on postexercise hypoglycemia risk in individuals with type 1 diabetes. Davey, RJ., Howe, W., Paramalingam, N., et al.[2013]

In a study involving nine adolescents with type 1 diabetes, it was found that glucose infusion rates needed to maintain stable blood sugar levels were higher during and shortly after exercise, indicating an increased risk of hypoglycemia immediately following physical activity.

The research revealed a biphasic pattern of glucose requirements, suggesting that adolescents may face both immediate and delayed risks of nocturnal hypoglycemia after exercising, highlighting the need for careful monitoring and management of glucose levels post-exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Glucose requirements to maintain euglycemia after moderate-intensity afternoon exercise in adolescents with type 1 diabetes are increased in a biphasic manner. McMahon, SK., Ferreira, LD., Ratnam, N., et al.[2022]

In individuals with type 1 diabetes, high-intensity interval exercise (HIIE) performed in a fasting state (AME) led to an increase in blood glucose levels, while postprandial exercise (PME) resulted in a decrease in blood glucose levels, indicating that the timing of exercise can significantly affect glucose responses.

The study, involving 12 physically active participants, found that PME was associated with a higher frequency of hyperglycemic events in the hours following exercise, suggesting that fasting HIIE may be a safer option for managing blood glucose levels during and after exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fasting May Alter Blood Glucose Responses to High-Intensity Interval Exercise in Adults With Type 1 Diabetes: A Randomized, Acute Crossover Study. Yardley, JE.[2022]

In a study involving 8 male type 1 diabetic patients, reducing premeal insulin doses significantly decreased the risk of exercise-induced hypoglycemia during postprandial exercises of varying intensities and durations.

Specifically, a 50% reduction in premeal insulin was effective for low-intensity exercise, while a 75% reduction was necessary for high-intensity exercise, leading to a 75% decrease in hypoglycemia incidents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guidelines for premeal insulin dose reduction for postprandial exercise of different intensities and durations in type 1 diabetic subjects treated intensively with a basal-bolus insulin regimen (ultralente-lispro). Rabasa-Lhoret, R., Bourque, J., Ducros, F., et al.[2022]

Postprandial exercise in individuals with type 1 diabetes can lead to significant declines in blood glucose levels, with the most pronounced effects observed during high-intensity continuous exercise, highlighting the importance of exercise intensity in managing glycaemic responses.

To prevent exercise-induced hypoglycaemia, it is crucial for individuals to reduce their mealtime insulin before exercising, with the extent of reduction depending on the exercise's duration and intensity, and to consider having a post-exercise snack to mitigate the risk of late-onset hypoglycaemia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of postprandial exercise on blood glucose levels in adults with type 1 diabetes: a review. Helleputte, S., Yardley, JE., Scott, SN., et al.[2023]

In a study involving 15 adults with type 1 diabetes, a 50% basal insulin rate reduction set 90 minutes before fasted walking resulted in better glucose stability and less fluctuation compared to carbohydrate intake alone or a basal rate reduction at exercise onset.

This pre-exercise basal rate reduction also led to higher levels of β-hydroxybutyrate and increased fat oxidation, suggesting it may be a more effective strategy for managing glucose levels during fasted exercise without the need for carbohydrates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Carbohydrate Requirements for Prolonged, Fasted Exercise With and Without Basal Rate Reductions in Adults With Type 1 Diabetes on Continuous Subcutaneous Insulin Infusion. McGaugh, SM., Zaharieva, DP., Pooni, R., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10459496/

Efficacy of Fasting in Type 1 and Type 2 Diabetes Mellitus Intermittent fasting decreases body weight and fat mass and improves blood pressure and insulin sensitivity [23,24]. The results of other ...

2. academic.oup.com academic.oup.com/jcem/article/104/1/111/5105939

Fasted High-Intensity Interval and Moderate-Intensity Exercise ... The current exercise guidelines for people with T1D report that aerobic exercise decreases blood glucose levels if performed during the postprandial period with ...

3. diabetesjournals.org diabetesjournals.org/care/article/44/2/610/35473/Carbohydrate-Requirements-for-Prolonged-Fasted

Carbohydrate Requirements for Prolonged, Fasted Exercise ... Exercising while fasted with type 1 diabetes facilitates weight loss; however, the best strategy to maintain glucose stability remains ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1499267124001059

An Aerobic Cooldown After Morning, Fasted Resistance ... Previous investigations showed that blood glucose concentration can increase [31,32] or decrease [33] during fasted aerobic exercise for people with type 1 ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06748963

Fasted Exercise Training in Type 1 Diabetes (FED-T1D) This study will compare the effects of 12 weeks of exercise before breakfast compared to 12 weeks of exercise after breakfast. It is expected that exercise ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6908414/

Physical Activity/Exercise and Diabetes: A Position ... In type 1 diabetes, aerobic training increases cardiorespiratory fitness, decreases insulin resistance, and improves lipid levels and endothelial function (14).

7. link.springer.com link.springer.com/article/10.1007/s00125-022-05781-8

prandial state dictates glycaemic responses to exercise in ... Overall, the trend from these studies is clear: on average, blood glucose does not decline, and will generally increase when exercise is ...

8. frontiersin.org frontiersin.org/journals/endocrinology/articles/10.3389/fendo.2022.1021800/full

Exercise, type 1 diabetes mellitus and blood glucose At present, the data suggests that fasted morning exercise triggers a rise in blood glucose following exercise, when compared to postprandial ...