20 Participants Needed

Fasted Exercise for Type 1 Diabetes

(FED-T1D Trial)

NB
RM
Overseen ByReid McClure, MSc
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: University of Alberta
Must be taking: Rapid insulin
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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 data supports the effectiveness of the treatment Fasted Exercise, Postprandial Exercise for Type 1 Diabetes?

Research shows that exercising after a meal (postprandial exercise) can help manage blood sugar levels in people with type 1 diabetes, but it requires careful insulin adjustments to prevent low blood sugar (hypoglycemia). Fasted exercise can aid in weight loss, but the best way to keep blood sugar stable during this type of exercise is still being studied.12345

Is fasted or postprandial exercise safe for people with type 1 diabetes?

Exercise can lower blood sugar levels in people with type 1 diabetes, which might lead to hypoglycemia (low blood sugar). To stay safe, it's important to adjust insulin doses and possibly eat a snack after exercising, especially if the exercise is intense or happens in the evening.12345

How is fasted exercise different from other treatments for type 1 diabetes?

Fasted exercise for type 1 diabetes is unique because it involves exercising without eating beforehand, which can help manage blood sugar levels differently compared to exercising after a meal. This approach may lead to smaller changes in blood sugar during high-intensity exercise, potentially reducing the risk of hypoglycemia (low blood sugar) that can occur with other exercise strategies.34567

What is the purpose of this trial?

This study compares aerobic exercise training performed before breakfast (i.e., in the fasted state) to similar training performed after breakfast in people with type 1 diabetes. Training will take place over 12 weeks.

Research Team

NG

Normand G Boule, PhD

Principal Investigator

University of Alberta

Eligibility Criteria

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.
I have been diagnosed with type 1 diabetes for at least 5 years.
HbA1c 7.0-9.9%
See 6 more

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.
I cannot do certain exercises because of serious health issues like severe nerve damage or eye problems from diabetes, or other conditions like bad arthritis.
Ongoing pregnancy or breastfeeding
See 4 more

Timeline

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Fasted ExerciseExperimental Treatment1 Intervention
Exercise training will be performed in the fasted state (i.e., before breakfast).
Group II: Postprandial ExerciseActive Control1 Intervention
Exercise will be performed in the postprandial period (i.e., after breakfast)

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials
957
Recruited
437,000+

Alberta Diabetes Institute

Collaborator

Trials
5
Recruited
130+

Findings from Research

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.
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 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.
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]
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.
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]

References

Glucose requirements to maintain euglycemia after moderate-intensity afternoon exercise in adolescents with type 1 diabetes are increased in a biphasic manner. [2022]
The effect of midday moderate-intensity exercise on postexercise hypoglycemia risk in individuals with type 1 diabetes. [2013]
Effects of postprandial exercise on blood glucose levels in adults with type 1 diabetes: a review. [2023]
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). [2022]
Carbohydrate Requirements for Prolonged, Fasted Exercise With and Without Basal Rate Reductions in Adults With Type 1 Diabetes on Continuous Subcutaneous Insulin Infusion. [2021]
Fasting May Alter Blood Glucose Responses to High-Intensity Interval Exercise in Adults With Type 1 Diabetes: A Randomized, Acute Crossover Study. [2022]
Exercise strategies for hypoglycemia prevention in individuals with type 1 diabetes. [2022]
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