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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up thirteen weeks following study initiation
Awards & highlights
HOME T1D Trial 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.Check my eligibility
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.See study design
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.
HOME T1D Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am either 18-30 or 45-65 years old.
HOME T1D Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ twelve weeks following study initiation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~twelve weeks following study initiation
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The effect of T1D on skeletal muscle health, quantified by physiological parameters (detailed in description)
Secondary outcome measures
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)
HOME T1D Trial Design
3Treatment groups
Experimental Treatment
Group I: Twelve-week ExerciseExperimental Treatment1 Intervention
Study participants will participate in an exercise program consisting of aerobic and resistance exercise. This arm will last twelve weeks.
Group II: One-week DetrainingExperimental Treatment1 Intervention
Study participants will undergo unilateral knee immobilization for a one-week period.
Group III: Four-week Re-trainingExperimental Treatment1 Intervention
Study participants will once again participate in an exercise program consisting of aerobic and resistance exercise. This arm will last four weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Exercise
2016
Completed Phase 1
~760
De-training
2013
N/A
~20
Find a Location
Who is running the clinical trial?
McMaster UniversityLead Sponsor
888 Previous Clinical Trials
2,600,287 Total Patients Enrolled
Thomas J Hawke, PhDPrincipal InvestigatorMcMaster University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have health problems that make it risky for you to take part in the study's exercise activities.I have been diagnosed with prediabetes.I am either 18-30 or 45-65 years old.I have a specific type of nerve damage due to diabetes.I have been hospitalized for diabetic ketoacidosis more than once.You have a body mass index (BMI) higher than 30, which means you are significantly overweight.You do not engage in at least 150 minutes of moderate-to-vigorous physical activity each week.I regularly use medication for inflammation, steroids, or pain relief.You have used cannabis, tobacco, or nicotine daily in the six months before the study starts.I have type 2 diabetes.
Research Study Groups:
This trial has the following groups:- Group 1: Four-week Re-training
- Group 2: One-week Detraining
- Group 3: Twelve-week Exercise
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are individuals aged twenty or higher able to take part in this investigation?
"This research endeavour is open to all adults between the ages of 18 and 65."
Answered by AI
Is this research endeavor presently enlisting volunteers?
"Clinicaltrials.gov reveals that this particular trial, initially posted on April 1st 2023 and last updated February 13th of the same year, is no longer open for recruitment. Fortunately, there are 361 other medical trials currently enrolling patients."
Answered by AI
Who qualifies for eligibility in this research project?
"This research is seeking 168 participants suffering from type 1 diabetes between the ages of 18-65. The main requirements are that applicants must either be aged 18-30 or 45-65, and their physical activity levels cannot exceed 150 minutes per week."
Answered by AI
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