SarcopeniaNCT04114383
Concurrent Assessment of Skeletal Muscle Mass and Synthesis/Breakdown in Old Age
An observational study of Sarcopenia and Muscle Atrophy, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
This study involves minimally-invasive techniques to measure muscle mass, muscle protein breakdown and synthesis simultaneously in older age. Read more about this study
- Who is it for?
- Ages 65 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia, Muscle Atrophy
- What is being tested?
- D3-Creatine, Deuterium Oxide and D3-3-methylhistidine
- How many people
- 37 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 7 Jun 2016to Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Generally healthy older adults
Who may be able to join
- Healthy volunteers of normal body mass index (BMI <35 kg/m2), aged 65-85 years
Who cannot join
- A BMI > 35 kg/m2
- Active cardiovascular disease:
- o angina, heart failure (class III/IV), arrhythmia, right to left cardiac shunt, recent cardiac event
- Cerebrovascular disease:
- o previous stroke, aneurysm (large vessel or intracranial), epilepsy
- Respiratory disease including:
Show all 13Show fewer
- o pulmonary hypertension, COPD
- Metabolic disease:
- o hyper and hypo parathyroidism, untreated hyper and hypothyroidism, Cushing's disease, type 1 or 2 diabetes
- Active inflammatory bowel or renal disease
- Malignancy
- Recent steroid treatment (within 6 months) or hormone replacement therapy
- Clotting dysfunction
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Derby Hospital Medical School
Derby, Derbyshire, DE22 3DT
About this study
Official title: Concurrent Assessment of Skeletal Muscle Mass and Synthesis/Breakdown in Old Age: Defining Diagnostics and the Aetiology of Sarcopenia to Identify "At-risk" Individuals and Appropriate Countermeasures
This study involves minimally-invasive techniques to measure muscle mass, muscle protein breakdown and synthesis simultaneously in older age.
Read the detailed description
Most people will have noticed that with age people become frail. This is principally due to wasting of skeletal muscle known as "sarcopenia". Crucially, sarcopenia is more than just a symptom of weakness and poor functional capacity; it exposes people to an increased risk of falls and fractures, impacting quality of life, independence, health status and ultimately lifespan. Muscles represent the largest organ in the body, making up over 50% of total body weight. Most people know that skeletal muscles are important for movement and to support the skeleton, but not everyone is aware of how important muscles are for whole-body health. For example, muscles represent a vast protein store containing amino acids (the building blocks of protein) which can be broken down in times of fasting, infection and disease in order to provide energy to help other vital organs. Because of the detrimental effects on health, and the associated health costs, sarcopenia is of grave concern. Therefore, there is a significant clinical need to pre-identify at-risk older individuals who have low muscle mass so that they can be offered an intervention (of diet, exercise or drug-based) before they suffer any of the potential problems outlined above. Current techniques for measuring whole-body muscle mass, including MRI and CT are time-consuming, expensive and in huge demand in hospital settings, meaning that muscle wasting conditions such as sarcopenia often go undiagnosed. In this project we propose a potential solution to this problem by developing a diagnostic of sarcopenia that requires only a single drink and subsequent urine collection. In addition, throughout this project we aim to explore the mechanisms underlying muscle wasting by assessing the muscle of those with low and 'normal' muscle mass.
- Conditions
- Sarcopenia, Muscle Atrophy
- Being tested
- D3-Creatine, Deuterium Oxide, D3-3-methylhistidine
- Medical subject headings
- Sarcopenia, Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D3-CreatineOther
30mg D3-Creatine to measure muscle mass
Deuterium OxideOther
Also called D2O, Heavy water
D2O provided to measure muscle protein synthesis
D3-3-methylhistidineOther
Also called D3-3MH
D3-3-methylhistidine is provided to measure muscle protein breakdown
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of D3-Creatine in Urine: 24 hours
To use 30mg of D3-Creatine to measure muscle creatine pool size (g) and whole-body muscle mass (kg) from urine samples taken between 0 and 72 hours. The 0-24 hours collection provides a measure of creatine spillover.
Measured: Up to 24 hours
Measurement of muscle mass using D3-Creatine: 48 hours
To use 30mg of D3-Creatine to measure muscle creatine pool size (g) and whole-body muscle mass (kg) from urine samples taken between 0 and 72 hours. The 0-24 hours collection provides a measure of creatine spillover, spot urines at 48 and 72 hours provide a measurement of the dilution of tracer in urinary creatinine and thus the total muscle creatine pool size.
Measured: 48 hours
Measurement of muscle mass using D3-Creatine: 72 hours
To use 30mg of D3-Creatine to measure muscle creatine pool size (g) and whole-body muscle mass (kg) from urine samples taken between 0 and 72 hours. The 0-24 hours collection provides a measure of creatine spillover, spot urines at 48 and 72 hours provide a measurement of the dilution of tracer in urinary creatinine and thus the total muscle creatine pool size.
Measured: 72 hours
Rate of dilution of D3-3MH by endogenous unlabelled 3MH release in blood
Using 10mg of D3-3-methylhistidine (D3-3MH) and subsequent multiple blood sampling between 24 and 30h, the rate of dilution of D3-3MH by endogenous unlabelled 3MH release provides a measure of the rate of whole-body muscle protein breakdown.
Measured: 6 hours (from 24 through to 30 hours)
Rates of Muscle Protein Synthesis
Using D2O, rate of muscle protein synthesis will be calculated, cumulatively, over 0-3 days by measuring deuterium labelling of alanine into protein from a muscle biopsy at 72 hours.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2019
- Study start7 Jun 2016
- Primary completion31 Jan 2020
- Study completionFeb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- Abbeyfield
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04114383
- Sponsor's protocol ID
- Abbeyfield
- Status last verified
- Oct 2019
- First submitted
- 5 Feb 2019
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concurrent Assessment of Skeletal Muscle Mass and Synthesis/Breakdown in Old Age: Defining Diagnostics and the Aetiology of Sarcopenia to Identify "At-risk" Individuals and Appropriate Countermeasures
- ClinicalTrials.gov ID
- NCT04114383
- Acronym / sponsor ID
- Abbeyfield
- Conditions
- Sarcopenia, Muscle Atrophy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- Abbeyfield
- Study start
- 7 Jun 2016 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- Feb 2020 (actual)
- First posted
- 3 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study involves minimally-invasive techniques to measure muscle mass, muscle protein breakdown and synthesis simultaneously in older age.
Detailed description
Most people will have noticed that with age people become frail. This is principally due to wasting of skeletal muscle known as "sarcopenia". Crucially, sarcopenia is more than just a symptom of weakness and poor functional capacity; it exposes people to an increased risk of falls and fractures, impacting quality of life, independence, health status and ultimately lifespan. Muscles represent the largest organ in the body, making up over 50% of total body weight. Most people know that skeletal muscles are important for movement and to support the skeleton, but not everyone is aware of how important muscles are for whole-body health. For example, muscles represent a vast protein store containing amino acids (the building blocks of protein) which can be broken down in times of fasting, infection and disease in order to provide energy to help other vital organs. Because of the detrimental effects on health, and the associated health costs, sarcopenia is of grave concern. Therefore, there is a significant clinical need to pre-identify at-risk older individuals who have low muscle mass so that they can be offered an intervention (of diet, exercise or drug-based) before they suffer any of the potential problems outlined above. Current techniques for measuring whole-body muscle mass, including MRI and CT are time-consuming, expensive and in huge demand in hospital settings, meaning that muscle wasting conditions such as sarcopenia often go undiagnosed. In this project we propose a potential solution to this problem by developing a diagnostic of sarcopenia that requires only a single drink and subsequent urine collection. In addition, throughout this project we aim to explore the mechanisms underlying muscle wasting by assessing the muscle of those with low and 'normal' muscle mass.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Generally healthy older adults
Key inclusion criteria (1 listed)
- Healthy volunteers of normal body mass index (BMI <35 kg/m2), aged 65-85 years
Key exclusion criteria (13 listed)
- A BMI > 35 kg/m2
- Active cardiovascular disease:
- o angina, heart failure (class III/IV), arrhythmia, right to left cardiac shunt, recent cardiac event
- Cerebrovascular disease:
- o previous stroke, aneurysm (large vessel or intracranial), epilepsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| D3-Creatine30mg D3-Creatine to measure muscle mass | Other | – |
| Deuterium OxideAlso: D2O, Heavy waterD2O provided to measure muscle protein synthesis | Other | – |
| D3-3-methylhistidineAlso: D3-3MHD3-3-methylhistidine is provided to measure muscle protein breakdown | Other | – |
Primary outcome
Measurement of D3-Creatine in Urine: 24 hours
Time frame: Up to 24 hours
To use 30mg of D3-Creatine to measure muscle creatine pool size (g) and whole-body muscle mass (kg) from urine samples taken between 0 and 72 hours. The 0-24 hours collection provides a measure of creatine spillover.
Measurement of muscle mass using D3-Creatine: 48 hours
Time frame: 48 hours
To use 30mg of D3-Creatine to measure muscle creatine pool size (g) and whole-body muscle mass (kg) from urine samples taken between 0 and 72 hours. The 0-24 hours collection provides a measure of creatine spillover, spot urines at 48 and 72 hours provide a measurement of the dilution of tracer in urinary creatinine and thus the total muscle creatine pool size.
Measurement of muscle mass using D3-Creatine: 72 hours
Time frame: 72 hours
To use 30mg of D3-Creatine to measure muscle creatine pool size (g) and whole-body muscle mass (kg) from urine samples taken between 0 and 72 hours. The 0-24 hours collection provides a measure of creatine spillover, spot urines at 48 and 72 hours provide a measurement of the dilution of tracer in urinary creatinine and thus the total muscle creatine pool size.
Rate of dilution of D3-3MH by endogenous unlabelled 3MH release in blood
Time frame: 6 hours (from 24 through to 30 hours)
Using 10mg of D3-3-methylhistidine (D3-3MH) and subsequent multiple blood sampling between 24 and 30h, the rate of dilution of D3-3MH by endogenous unlabelled 3MH release provides a measure of the rate of whole-body muscle protein breakdown.
Rates of Muscle Protein Synthesis
Time frame: 3 days
Using D2O, rate of muscle protein synthesis will be calculated, cumulatively, over 0-3 days by measuring deuterium labelling of alanine into protein from a muscle biopsy at 72 hours.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcopenia and Muscle Atrophy, run by University of Nottingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of D3-Creatine in Urine: 24 hours (time frame: Up to 24 hours). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2020.