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Exercise + Multivitamin Supplement for Myotonic Dystrophy (DM1HBET Trial)
Phase 3
Waitlist Available
Research Sponsored by McMaster University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 months from enrolment
Awards & highlights
DM1HBET Trial Summary
This trial is investigating if exercise and a multivitamin supplement can help people with a genetic muscle disease called "Myotonic dystrophy type 1" (DM1) to improve their symptoms and quality of life.
Who is the study for?
This trial is for men and women aged 19-60 with Myotonic Dystrophy type 1 (DM1), having CTG repeats between 100-1000. Participants should have a BMI of 18.5-29.9, be physically inactive, and able to walk between 250-500 meters in six minutes without severe heart rhythm abnormalities.Check my eligibility
What is being tested?
The study tests if a home-based exercise program combined with either a multi-ingredient supplement or placebo can improve muscle function and body composition in DM1 patients over the course of 16 weeks.See study design
What are the potential side effects?
Potential side effects may include typical exercise-related issues like muscle soreness or strain. The multi-ingredient supplement could cause digestive discomfort or allergic reactions, depending on its contents.
DM1HBET Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 months from enrolment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 months from enrolment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Body Composition Index
VO2 Max
Secondary outcome measures
5x sit to stand
6-minute walk test
Grip strength
+5 moreDM1HBET Trial Design
3Treatment groups
Active Control
Placebo Group
Group I: CONTROLActive Control1 Intervention
Healthy control subjects who will not undergo study intervention and will be used for baseline measurements and outcomes.
Group II: DM1 + HBEXT + MISActive Control2 Interventions
Participants will be asked to undergo 16 weeks of home-based training and asked to take one dose of a multi-ingredient supplement per day.
Group III: DM1 + HBEXT + PLAPlacebo Group2 Interventions
Participants will be asked to undergo 16 weeks of home-based training and asked to take one dose of a multi-ingredient supplement placebo per day.
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Who is running the clinical trial?
McMaster UniversityLead Sponsor
880 Previous Clinical Trials
2,597,768 Total Patients Enrolled
1 Trials studying Myotonic Dystrophy
13 Patients Enrolled for Myotonic Dystrophy
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My BMI is over 30.I am between 19 and 60 years old and have been diagnosed with DM1.I need more than 2 medications to manage my high blood pressure.I have diabetes and take more than one medication for it.I have not had a heart attack in the last 6 months.My genetic test shows I have 100-1000 CTG repeats.I have severe nerve pain or numbness in my hands or feet.I use painkillers or anti-inflammatory drugs.I can walk less than 250 meters in 6 minutes for more than 2 weeks.I have severe osteoporosis.I use more than two medications for my asthma.I am not taking medications like corticosteroids that affect protein metabolism.I am a healthy man or woman.I have severe joint pain or active injuries in my muscles or bones.I have a heart block.My kidney function is normal.I take multiple medications for my heart failure.I had a stroke and still have weakness on one side of my body.I have lost a lot of weight in the last 3 months.I have a lung condition that limits my breathing capacity.I can walk between 250 to 500 meters in 6 minutes.I have a known liver condition.I am able to understand and consent to my treatment.
Research Study Groups:
This trial has the following groups:- Group 1: CONTROL
- Group 2: DM1 + HBEXT + MIS
- Group 3: DM1 + HBEXT + PLA
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Does this research trial offer volunteer opportunities?
"To partake in the study, individuals must have myotonic dystrophy and fall between 19-60 years old. The researchers are hoping to enroll around sixty people for this trial."
Answered by AI
Are those in the later stages of life eligible to participate in this clinical experiment?
"To be a viable candidate, one must meet the age criteria of being between 19 and 60 years old."
Answered by AI
Are there any safety concerns associated with the therapeutic combination of DM1 + HBEXT + MIS?
"Due to the support from prior clinical data, DM1 + HBEXT + MIS has been rated a 3 in terms of safety by our team at Power. This indicates that it is currently undergoing Phase 3 trials with evidence suggesting its efficacy and multiple rounds indicating its safety."
Answered by AI
What key aims are researchers hoping to achieve through this medical experiment?
"This 4 month trial looks to measure Body Composition Index as its main objective. Other metrics of interest include 6-minute Walk Test, Timed Up and Go, and Leg Muscle Strength which are evaluated via changes in distance covered, time taken to complete a task, and isometric knee extension respectively."
Answered by AI
Are any additional volunteers being sought for this experiment?
"This medical trial, which was originally published on the 1st of May 2023 and last updated on 28th April 2023 is not recruiting participants. However, 12 other clinical trials are open for enrolment at this time."
Answered by AI
Who else is applying?
What site did they apply to?
McMaster University Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
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