60 Participants NeededMy employer runs this trial

Exercise Training for Type 1 Diabetes

(ZQL010 Trial)

ZL
LH
Overseen ByLee Hartline, MEd
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: University of Virginia
Must be taking: Insulin
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how High Intensity Interval Training (HIIT) affects individuals with Type 1 diabetes, focusing on cardio fitness and insulin resistance (how well the body uses insulin). Researchers aim to compare these effects between individuals with Type 1 diabetes and healthy individuals, and to determine if being overweight influences the outcomes. Participants will be grouped based on Type 1 diabetes status and weight. Suitable candidates have had Type 1 diabetes for over 5 years, are not currently very active, and do not have other major health issues. As an unphased trial, this study provides a unique opportunity to enhance understanding of how exercise impacts diabetes management.

Do I have to stop taking my current medications for the trial?

You need to stop taking estrogen/progesterone medications at least 3 months before the study, but you can continue using intrauterine devices. If you're on non-insulin medications, you should have been using them stably for over 6 months. The trial does not specify other medication restrictions, but you cannot participate if you're using certain heart-related medications.

What prior data suggests that High Intensity Interval Training is safe for people with Type 1 diabetes?

Research has shown that High Intensity Interval Training (HIIT) is generally safe for people with Type 1 diabetes. Studies have found that HIIT can improve aerobic capacity, or how well the body uses oxygen, without causing a dangerous drop in blood sugar levels. Maintaining steady blood sugar is crucial for individuals with diabetes.

One study found that HIIT provides a safe and effective way for people with Type 1 diabetes to exercise and manage their health without extra risks. Another study confirmed that even shorter HIIT sessions can be safely performed by those with the condition.

These findings suggest that HIIT is well-tolerated and does not pose major safety concerns for people with Type 1 diabetes. However, as with any exercise, consulting a healthcare provider before starting a new program is advisable.12345

Why are researchers excited about this trial?

Researchers are excited about using High Intensity Interval Training (HIIT) for managing Type 1 Diabetes because it offers a non-drug approach to improving glucose control. Unlike traditional treatments such as insulin therapy and dietary management, HIIT involves short bursts of intense exercise followed by periods of rest or low activity, which can enhance insulin sensitivity and glucose uptake more efficiently. This method could potentially lead to better blood sugar management and overall health benefits without the side effects associated with medications. Additionally, HIIT may be more engaging and sustainable for patients, making it an appealing complement to existing diabetes management strategies.

What evidence suggests that High Intensity Interval Training is effective for improving cardio fitness in people with Type 1 diabetes?

This trial will evaluate the effects of High Intensity Interval Training (HIIT) on individuals with Type 1 diabetes, both normal weight and overweight, as well as healthy controls. Studies have shown that HIIT can greatly improve heart and lung fitness in people with Type 1 diabetes. It helps the body use insulin more effectively, leading to better blood sugar control. Research also shows that HIIT can lower blood sugar more effectively than exercises like walking. Additionally, HIIT can improve heart health and reduce the risk of low blood sugar episodes. Early findings suggest that even short HIIT programs can positively impact fitness and insulin needs for people with Type 1 diabetes.678910

Who Is on the Research Team?

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Zhenqi Liu, MD

Principal Investigator

University of Virginia

Are You a Good Fit for This Trial?

This trial is for men and women aged 21-50 who are either healthy, have Type 1 diabetes, are overweight/obese, or both. Participants must meet specific BMI ranges and be stable on medications. People with serious health issues, recent smokers, pregnant/nursing women, or those very active in exercise cannot join.

Inclusion Criteria

Body mass index: 19 to 27 kg/m2 for control and T1D, 30 to 40 kg/m2 (27.5 to 37.5 for Asian Americans) for obesity and T1D + obesity. BMI limited to 40 kg/m2 (37.5 for Asian Americans) for easier vascular access and cardiac imaging
I have been on the same non-insulin meds for over 6 months and stopped hormone pills 3 months ago.
I am between 21 and 50 years old.
See 1 more

Exclusion Criteria

Pregnant (as evidenced by positive pregnancy test) or nursing women
I have taken birth control pills in the past 3 months.
I currently smoke or quit smoking less than 5 years ago.
See 11 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Exercise Training

Participants undergo a High Intensity Interval Training (HIIT) exercise program

15 weeks

Follow-up

Participants are monitored for changes in VO2max and insulin-mediated changes in muscle

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • High Intensity Interval Training

Trial Overview

The study tests how a high intensity interval training (HIIT) exercise program affects insulin sensitivity and heart-lung fitness in people with Type 1 diabetes—with or without obesity—compared to healthy controls before and after the program.

How Is the Trial Designed?

4

Treatment groups

Active Control

Group I: Type 1 diabetes - normal weightActive Control1 Intervention
Group II: Control - normal weightActive Control1 Intervention
Group III: Overweight controlActive Control1 Intervention
Group IV: Type 1 diabetes - overweightActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Virginia

Lead Sponsor

Trials
802
Recruited
1,342,000+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38904921

Effects of HIIT Interventions on Cardiorespiratory Fitness ...

Our systematic review and meta-analysis show that T1DM patients who performed a HIIT intervention significantly improved cardiorespiratory fitness and reduced ...

Effectiveness and Safety of High-Intensity Interval Training in ...

A single session of HIIT involving 10 × 1 minute at ∼90% of maximal aerobic power has been shown to significantly reduce postprandial hyperglycemia assessed by ...

Effects of high-intensity intermittent exercise on glucose ...

HIIT has been shown to improve glucose and lipid metabolism in patients with type 2 diabetes, especially in HbA1c, TC, TG, and HDL.

Effect of High-Intensity Interval Training on Quality of Life ...

These data suggest that HIIT prevents hypoglycemia as well as previous studies reported [12,21]. Our findings show that the HIIT group ...

The effects of high-intensity interval training on glucose ...

These findings revealed that HIIT intervention led to significant improvement in glycemic control and insulin resistance in subjects with diabetes compared with ...

Toward Individualized High-Intensity Interval Training in ...

High-intensity interval training (HIIT) is presented as a safe, effective, and time-efficient strategy for individuals with type 1 diabetes, ...

Effect of High-Intensity Interval Training on Glycemic Control in ...

Overall, there was no significant reduction in HbA1c with a 12-week HIIT intervention in adults with type 1 diabetes. However, glycemic control may improve for ...

High-intensity interval training: safe and beneficial physical ...

High intensity interval training (HIIT) has shown an improvement in aerobic capacity without a detrimental decline in blood glucose and home‐ ...

Isoenergetic High Intensity Interval Training and Moderate ...

Type 1 diabetes (T1D) is associated with increased risk of poor cardiometabolic health. Regular exercise is recommended for optimal management ...

Continuous moderate and intermittent high-intensity ...

IHE appeared to limit the glycemic drop compared to CME. Performing 20-min CME or IHE was not associated with increased hypoglycemic risk compared to being ...