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Exercise for Type 1 Diabetes (HOME T1D Trial)

N/A

Recruiting

Led By Thomas J Hawke, PhD

Research Sponsored by McMaster University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age of 18-30 or 45-65

Be older than 18 years old

Must not have

Prediabetes

Atypical or Grade 2b diabetic sensorimotor polyneuropathy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up thirteen weeks following study initiation

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to reduce complications of Type 1 Diabetes & improve insulin sensitivity in males & females by determining the impacts of T1D on the human body & its responses to exercise.

Who is the study for?

This trial is for adults aged 18-30 or 45-65 with Type 1 Diabetes who are not very active, doing less than the recommended amount of weekly exercise. It's not for those hospitalized multiple times for diabetic ketoacidosis, on certain medications, overweight (BMI >30), recent users of cannabis/tobacco/nicotine, or with other health issues that make exercising risky.

What is being tested?

The study looks at how Type 1 Diabetes affects muscle and blood vessels in men and women over time. It will test the effects of starting an exercise program and then stopping it ('de-training') to see what happens to their muscles and insulin sensitivity.

What are the potential side effects?

While specific side effects aren't listed, exercise can sometimes cause low blood sugar (hypoglycemia) in people with Type 1 Diabetes. Participants may also experience typical exercise-related discomforts like muscle soreness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am either 18-30 or 45-65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with prediabetes.

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I have a specific type of nerve damage due to diabetes.

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I have been hospitalized for diabetic ketoacidosis more than once.

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I have type 2 diabetes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ seventeen weeks following study initiation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~seventeen weeks following study initiation

This trial's timeline: 3 weeks for screening, Varies for treatment, and seventeen weeks following study initiation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The effect of T1D on skeletal muscle health, quantified by physiological parameters (detailed in description)

Secondary study objectives

The acute effect of a detraining period on skeletal muscle health compared to baseline, quantified by physiological parameters (detailed in description)

The effect of a detraining period on skeletal muscle health compared to baseline, quantified by physiological parameters (detailed in description)

The effect of twelve weeks of exercise on skeletal muscle health compared to baseline, quantified by physiological parameters (detailed in description)