eucine and ACEi to treat sarcopenia

Phase 4

Completed

• Conditions: Topic: Primary Care, Musculoskeletal disorders, Ageing; Subtopic: Musculoskeletal (all Subtopics), Ageing, Ageing; Disease: Musculoskeletal, All Diseases, All Ageing; Musculoskeletal Diseases; Sarcopenia

• Registration Number: ISRCTN90094835
• Lead Sponsor: HS Tayside

Brief Summary

2018 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/29301558 protocol 2022 Results article in https://doi.org/10.3310/LLBX6901 (added 10/03/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-02-18
• Study Completion: 2020-06-30
• Last Update Posted: 20 March 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 145

Inclusion Criteria

1. Age 70 and over
2. Sarcopenia criteria according to EWGSOP definition, based on:
2.1. Low total skeletal muscle mass on BioImpedance Assay (BIA) using the BIA 101 device (<13Kg for women, <20.5Kg for men)
2.2. Either low gait speed (<0.8 m/s on 4m walk) or low handgrip strength (<20Kg for women, <30Kg for men)

Exclusion Criteria

1. Contraindications or existing indications to therapies or placebo
1.1. Known clinical diagnosis of chronic heart failure (by European Society of Cardiology criteria)
1.2. Confirmed LV systolic dysfunction on any imaging modality
1.3. Known aortic stenosis (peak gradient >30mmHg)
1.4. Systolic BP<90 mmHg (supine)
1.5. Dizziness on standing associated with a postural drop of >20/10mmHg (asymptomatic orthostatic hypotension will not be a contraindication)
1.6. Serum Creatinine >180 umol/L or eGFR<30ml/min by MDRD4 calculation
1.7. K>5.0 mmol/L; Na<130 mmol/L
1.8. Using ACEi, Angiotensin receptor blocker, aldosterone blocker or leucine already
1.9. Previous adverse reaction to ACEi or leucine
1.10. Current use of oral NSAIDs (aspirin is permitted, as are topical NSAIDs)
1.11. Lactose intolerance
2. Contraindications to consent or undertaking study outcomes
2.1. Peripheral oedema present above knee level
Unable to mobilise without human assistance (walking aids allowed)
2.2. Unable to give written informed consent
2.3. Currently enrolled in another research study, or less than 30 days since completing another research study
3. Overlap with other myopathic conditions or important confounders
3.1. Currently enrolled in a time-limited exercise-based rehabilitation programme
3.2. Any progressive neurological or malignant condition with life expectancy <6 months
3.3. Severe COPD (GOLD stage IV)
3.4. Known myositis
3.5. Self-reported weight loss of >10% in last 6 months (to exclude significant cachexia)
3.6. Known uncontrolled thyrotoxicosis
3.7. 7.5mg/day or greater prednisolone use (or equivalent)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Between group difference in Short Physical Performance Battery (SPPB) score at 12 months

Secondary Outcome Measures

Name	Time	Method
<br> Between group differences in:<br> 1. Appendicular muscle mass/height squared (measured by dual energy-X ray absorptiometry)<br> 2. Grip strength<br> 3. Quadriceps strength (handheld dynamometry)<br> 4. 6 minute walk test<br> 5. Gait speed (4m walk)<br> 6. Chair stands (Sit to stand test x 10)<br> 7. Activities of daily living (Nottingham extended ADL questionnaire) and quality of life (EuroQol 5D questionnaire).<br> 8. HOMA IR (Homeostatic Index of insulin resistance; measured from glucose and insulin levels)<br> 9. Falls frequency, collected by monthly falls diary<br> 10. Biomarkers of muscle metabolism and predictors of response to treatment: baseline 3 and 12 months<br><br> Measured at baseline, 6 and 12 months, except for muscle mass, which is baseline and 12 months<br>