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NCT05848830: DM1HBET
Home-based Training and Supplementation in DM1 Patients
Phase 3 trial testing Mult-ingredient supplement in Myotonic Dystrophy 1 in 60 participants. Status unknown.
1 January 2025
Quick facts
| Lead sponsor | McMaster University |
|---|---|
| Phase | Phase 3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | factorial |
| Masking | triple |
| Primary purpose | supportive care |
| Enrollment | 60 |
| Start date | 1 January 2024 |
| Primary completion | 1 January 2025 |
| Estimated completion | 1 January 2025 |
| Sites | 1 location across Canada |
Drugs / interventions tested
- Mult-ingredient supplement
- Placebo
- Concurrent exercise training
Conditions studied
- Myotonic Dystrophy 1 — all drugs for Myotonic Dystrophy 1 →
Sponsor
McMaster University
Who can join
Adults 19 to 60, any sex, with Myotonic Dystrophy 1. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Myotonic dystrophy type 1 (DM1) is a rare genetic disease that affects about 1 in 2100 people. Patients diagnosed with DM1 present with many symptoms, however, their muscles are mainly affected. DM1 patients experience a gradual loss of muscle, followed by an increase in body fat percentage, which makes them weaker, resulting in difficulties to perform activities of daily living, such as climbing stairs, and understandably, this affects their quality of life. DM1 currently does not have a cure. Therefore, it is very important to find ways in which we can help DM1 patients to improve their symptoms, and hopefully, improve their quality of life, and possibly improve disease prognosis. Exercise is known to improve muscle quality and function. In addition, we hypothesize that a multi-ingredient supplement (MIS) for muscle health and antioxidants for fat loss, might show improved benefits on top of exercise. Therefore, we will investigate the effects of 16-week home-based concurrent training, with MIS or placebo, on body composition, and functional measures. Lastly, we will investigate muscle adaptations in DM1 and following study intervention
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05848830
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Related trials
Other recruiting trials for Myotonic Dystrophy 1
Currently open trials in the same condition.
- NCT07385443 — The Spanish National Registry for Myotonic Dystrophy Type 1 · recruiting
- NCT06378216 — Myotonic Dystrophy Type 1 Congenital and Juvenile Form: From Diagnosis to Rehabilitation [MDCJ-NeuBeRe] · recruiting
- NCT03981575 — Estab Biomarkers and Clinical Endpoints in Myotonic Dystrophy Type 1 (END-DM1) · recruiting
Other McMaster University trials
Trials by the same sponsor.
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- NCT07408128 — Partner4Exercise Randomized Controlled Trial · Phase 2, PHASE3 · not yet recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05848830 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by McMaster University
- Last refreshed: 19 October 2023
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