Muscle Ageing Sarcopenia Study Lifecourse (MASS Lifecourse)

Sarcopenia Clinical Trial

— MASS_LC  

Official title:

Muscle Ageing Sarcopenia Study_Lifecourse (MASS_Lifecourse): Establishing a Life Course Cohort for Advances in the Prevention, Diagnosis and Treatment of Sarcopenia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04239495
• Other study ID #: 8734
• Status: Recruiting
• Start date: October 9, 2018
• Est. completion date: March 31, 2021

Study information

• Verified date: January 2020
• Source: Newcastle-upon-Tyne Hospitals NHS Trust
• Contact: Richard M Dodds, MBBS PhD
• Phone: +44 (0) 1912081319
• Email: richard.dodds[@]ncl.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Sarcopenia is the loss of muscle mass and function with age. It has been recognised as an important health problem because it is common in older adults and associated with decline in physical function as well as a reduced quality of life. Sarcopenia can also lead to serious health consequences in terms of increased disability and the need for increased health and social care.

There is considerable interest in understanding what causes sarcopenia in order to develop new approaches to prevention, diagnosis and treatment. To gain a detailed understanding of sarcopenia across a range of ages, we have designed the Muscle Ageing Sarcopenia Study (MASS_Lifecourse) in collaboration with members of the public and patients.

Description:

We aim to recruit 160 participants from Newcastle upon Tyne across an age range of 45-85 years from primary care, secondary care and the NIHR (National Institute for Health Research) Bioresource. Participants will receive a home visit from a researcher to complete a detailed health profile. Participants will then be invited to attend a clinical visit at Newcastle's Campus for Ageing and Vitality for imaging and muscle biopsy. A subsequent clinical visit will involve a fasting blood test, follow-up of the biopsy site and gather participants' views about taking part in the study.

The aims of the study:

1. To determine if it is acceptable and feasible to recruit adults across a range of ages to undergo detailed studies of skeletal muscle including biopsy

2. To understand how lifestyle is related to the characteristics of muscle

3. To use advances in technology (an omics approach) to identify mechanisms of sarcopenia and biomarkers for early diagnosis

4. To use findings from 2 and 3 to develop new approaches to treatment and also to invite participants to relevant trials

5. To secure funding for maintaining and expanding the cohort

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: March 31, 2021
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 85 Years

Eligibility

Inclusion Criteria:

Primary care source:

• Registered patient with one of the GP (General Practice) surgeries identified as PIC (Participant Identification Centre) via North East and North Cumbria Clinical Research Network.

Secondary care source:

• Attending a NuTH (Newcastle upon Tyne Hospitals NHS Foundation Trust) clinical area.

NIHR Bioresource:

• Participants identified by the NIHR Bioresource Centre Newcastle as being eligible for the study and who have not previously expressed a wish to no longer be contacted about further studies.

For all recruitment sources:

• Has capacity to consent.

• Within the study age range (45-85 years).

• Not taking any anticoagulant or antiplatelet medications (see below under exclusion criteria), with the exception of aspirin being taken for primary prevention (i.e. where there is no diagnosis of cardiovascular disease).

Exclusion Criteria:

• Inability to give informed consent.

• As the study involves biopsy of skeletal muscle, individuals who are taking medications that increase bleeding risk are excluded, specifically: i. anti-coagulant medication: warfarin, injected low-molecular weight heparins such as dalteparin, and direct oral anticoagulant drugs such as rivaroxaban and apixaban.

ii. anti-platelet medication such as clopidogrel or prasugrel. This also includes aspirin where an individual has a known history of cardiovascular disease. Aspirin being taken where there is no history of cardiovascular disease is acceptable, as we would consider there to be minimal risk of stopping the aspirin for 14 days prior to biopsies.

• Individuals known to have diabetes mellitus, due to the increased risk of infection at the biopsy sites.

• Individuals currently taking medication that suppresses the immune system (such as prednisolone or methotrexate), due to the increased risk of infection or poor healing of the biopsy sites.

• Pregnancy, due to the exposure to small amount of ionising radiation during the DXA scan.

• Individuals who use a wheelchair or who are unable to walk without assistance, as we would anticipate that the muscle biopsy procedure would not be feasible in these groups.

• An individual who the NuTH clinician / GP feels it is inappropriate for the researchers to approach - the NuTH clinician / GP may consider an individual unsuitable for approach for reasons such as end stage terminal disease or safety risk.

Related Conditions & MeSH terms

• Sarcopenia

Intervention

Other:
• Observational study: range of clinical and lifestyle factors
Medical conditions and medications. Educational and occupational history. Lifestyle exposures, assessed using reduced Food Frequency Questionnaire, Rapid Assessment of Physical Activity questionnaire and objectively-measured physical activity levels over 7 days using a GeneActiv wrist-worn accelerometer (Activinsights, Cambridge, UK).

Locations

Country	Name	City	State
United Kingdom	Clinical Ageing Research Unit	Newcastle upon Tyne	Tyne And Wear

Sponsors (1)

Lead Sponsor	Collaborator
Newcastle-upon-Tyne Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sarcopenia phenotype- grip strength	Maximum grip strength (Kg)	Baseline
Primary	Sarcopenia phenotype- chair rise time	Time to complete 5 chair rises (seconds)	Baseline
Primary	Sarcopenia phenotype- appendicular lean mass	Appendicular lean mass from DXA Scan (Kg)	Baseline
Primary	Sarcopenia phenotype- walking speed	Usual walking speed (m/s)	Baseline
Secondary	Presence of Frailty	Fried frailty Score	Baseline
Secondary	Presence of Frailty	Electronic frailty index (EFI) Score	Baseline
Secondary	Cognitive and Psychosocial Function	Montreal Cognitive Assessment (MoCA) Score	Baseline
Secondary	Cognitive and Psychosocial Function	Standardised mini-mental state examination (SMMSE) Score	Baseline
Secondary	Geriatric Depression Scale	Geriatric Depression Scale Score	Baseline
Secondary	Patient-reported survey of patient health	Short Form 36 (SF-36)	Baseline