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Myotonic Dystrophy 1

Home-based Training and Supplementation in DM1 Patients

Sponsored by McMaster University

About this trial

Last updated 2 years ago

Study ID

15550

Status

Not yet recruiting

Type

Interventional

Phase

Phase 3

Placebo

Yes

Accepting

18-75 Years
19 to 60 Years
All
All

Trial Timing

Ended 5 months ago

What is this trial about?

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

What are the Participation Requirements?

Age and sex-matched controls inclusion criteria:

- Healthy men and women

- Normal BMI (BMI 18.5 - 24.9 kg/m2)

Inclusion Criteria for DM1 patients:

- Male or female clinically diagnosed with DM1 (age 19 - 60 y).

- CTG repeats 100-1000.

- Normal weight (BMI 18.5 - 24.9 kg/m2) or overweight (BMI 25 - 29.9 kg/m2).

- Physically inactive (< 1 hour of formal exercise/week).

- 6-minute walk test score between 250 - 500 meters

- ECG with PR interval < 225 ms and QRS duration < 125 ms.

Exclusion Criteria for DM1 patients:

- Smoking

- Obese (BMI > 30.0 kg/m2)

- Physically active (> 1-2 hour of formal exercise/week)

- 6-minute walk test score <250 meters, chronic (> 2 weeks)

- Use of narcotic analgesic or anti-inflammatory drugs

- Type 1 or 2 diabetes (more than one anti-diabetic drug)

- Cardiovascular disease (recent myocardial infarction (< 6 months)

- Uncontrolled hypertension requiring more than 2 medications.

- Congestive heart failure requiring more than one medication for control.

- Cardiac conduction block (as above)

- Renal disease (creatinine > 140)

- Known liver disease

- Cognitive impairments limiting ability to provide informed consent

- Previous stroke with residual hemiparesis

- Active musculoskeletal injuries and/or severe osteoarthritis

- Significant weight loss in the 3-month period prior to the study

- Severe peripheral neuropathy

- Severe osteoporosis

- Use of medications known to affect protein metabolism (i.e. corticosteroids)

- Chronic obstructive or restrictive pulmonary disease (FVC < 70% of age predicted
mean value)

- Asthma requiring more than two medications.

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Location

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