Acipimox to improve muscle functio

Not Applicable

Completed

• Conditions: Sarcopenia, muscle weakness; Musculoskeletal Diseases; Other specified disorders of muscle

• Registration Number: ISRCTN87404878
• Lead Sponsor: ewcastle upon Tyne Hospitals NHS Foundation Trust

Brief Summary

2024 Protocol article in https://pubmed.ncbi.nlm.nih.gov/38417968/ (added 05/03/2024)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-29
• Study Completion: 2024-03-30
• Last Update Posted: 8 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

Current participant inclusion criteria as of 08/12/2023:
1. Age 65 years and over
2. Low maximum handgrip strength (<16kg for women, <27kg for men) or 5 times sit to stand >15 seconds
3. Walk speed <=0.8 m/s on 4-metre walk test

Previous participant inclusion criteria:
1. Age 65 years or over
2. Low maximum handgrip strength (<16kg for women, <27kg for men)
3. Walk speed <=0.8 m/s on 4 metre walk test

Exclusion Criteria

1. General:
1.1. Allergy to acipimox or other niacin-related products
1.2. Allergy or intolerance of aspirin
1.3. Unable to give written informed consent
1.4. Currently enrolled in another intervention study (observational studies are permitted)
1.5. Currently participating in supervised exercise classes or physiotherapy
1.6. Any progressive neurological or malignant condition with life expectancy <6 months
2. Safety of Acipimox and Aspirin:
2.1. eGFR <45ml/min/1.73m² (a measure of kidney function)
2.2. Taking statin medication or fibrate medication
2.3. Active peptic ulcer disease or indigestion
3. Safety of muscle biopsy and MRI:
3.1. Platelets <100x10^9/L at screening (contraindication to muscle biopsy)
3.2. Presence of a bleeding tendency or use of oral or injectable anticoagulant medication
3.3. Antiplatelet agents other than low dose (75mg once daily) aspirin
3.4. Unable to feel quadriceps muscle in leg to locate where to biopsy
3.5. Contraindications to MRI scanning (mild claustrophobia is not a contraindication)
4. Other causes of skeletal myopathy:
4.1. Liver function tests (bilirubin, ALT, alkaline phosphatase) >3x upper limit of normal
4.2. Symptomatic (NYHA class II-IV) chronic heart failure (diagnosed according to European Society of Cardiology guidelines)
4.3. Severe Chronic obstructive pulmonary disease (GOLD stage IV)
4.4. Known myositis or other established myopathy (muscle disease)
4.5. Self-reported weight loss of >10% in last 6 months (to exclude significant cachexia)
4.6. Known uncontrolled thyrotoxicosis (overactive thyroid disease)
4.7. 7.5mg/day or greater prednisolone use (or equivalent) (steroid that can cause muscle weakness)

Study & Design

• Study Type: Interventional
• Study Design: Not specified