Concurrent Assessment of Skeletal Muscle Mass and Synthesis/Breakdown in Old Age

NCT04114383 | Completed

• 1 other identifier: Abbeyfield
• Study Type: observational
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

This study involves minimally-invasive techniques to measure muscle mass, muscle protein breakdown and synthesis simultaneously in older age.

Conditions

Sarcopenia; Muscle Atrophy

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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.

  3 days

Interventions

D3-Creatine OTHER

30mg D3-Creatine to measure muscle mass

Deuterium Oxide OTHER

D2O provided to measure muscle protein synthesis

Also known as: D2O, Heavy water

D3-3-methylhistidine OTHER

D3-3-methylhistidine is provided to measure muscle protein breakdown

Also known as: D3-3MH

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Generally healthy older adults

You may qualify if:

• \- Healthy volunteers of normal body mass index (BMI \<35 kg/m2), aged 65-85 years

You may not qualify if:

• 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:
• 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

Sponsors & Collaborators

• University of Nottingham: lead
• Abbeyfield: collaborator

Study Sites (1)

Royal Derby Hospital Medical School

Derby, Derbyshire, DE22 3DT, United Kingdom

Location

MeSH Terms

Conditions

Sarcopenia; Muscular Atrophy

Interventions

Deuterium Oxide

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Water; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Deuterium; Hydrogen; Elements; Gases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2019
• First Posted: October 3, 2019
• Study Start: June 7, 2016
• Primary Completion: January 31, 2020
• Study Completion: February 1, 2020
• Last Updated: March 25, 2020

Record last verified: 2019-10

Locations

GB (1)