NCT03113279

Brief Summary

Two independent, but interrelated conditions that have a growing impact on healthy life expectancy and health care costs in developed nations are the age related loss of muscle mass (sarcopenia) and obesity. Sarcopenia affects approximately one third of adults over 60 years of age and more than 50% of those over 80 years, which is of concern when one considers that the most rapidly expanding population demographic in the UK is adults \>80 years of age. Skeletal muscle is important in regulating blood glucose and insulin sensitivity. Thus, sarcopenia may play a role in exacerbating insulin resistance and progression toward Type II diabetes (T2D). Indeed, the highest incidence of T2D in the UK has been noted to occur in adults \>65 years. Obesity is a major risk factor for chronic diseases including T2D and cardiovascular disease. Progression towards obesity is associated with a concomitant decrease in muscle mass, producing an unfavorable ratio of fat to muscle. Thus, obesity in old age may exacerbate the progression of sarcopenia. For the proposed study the investigators will conduct preliminary laboratory tests to characterize body composition, insulin sensitivity, systemic inflammation, aerobic capacity and muscle protein metabolism (in the fasted and fed state) in healthy older and obese older adults for comparison against healthy young individuals.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 28, 2017

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 13, 2017

Completed
Last Updated

April 13, 2017

Status Verified

April 1, 2017

Enrollment Period

1.6 years

First QC Date

March 28, 2017

Last Update Submit

April 12, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Myofibrillar protein synthesis rates via mass spectrometry

    Postabsorptive and postprandial myofibrillar protein synthesis rates between groups and following the activity intervention

    2 years

Secondary Outcomes (9)

  • Muscle fibre properties via immunohistochemical staining

    2 years

  • Muscle fibre lipid content immunofluorescent staining

    2 years

  • Physical activity levels via accelerometry

    2 years

  • Inflammation via plasma/insulin assays

    2 years

  • Insulin sensitivity via plasma assays

    2 years

  • +4 more secondary outcomes

Study Arms (3)

Obese older individuals

Obese older individuals

Lean older individuals

Lean older individuals

Young lean individuals

Young lean individuals

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

* Young lean healthy inidivduals aged 18-35. * Lean healthy older individuals aged 65-85. * Obese inactive older individuals aged 65-85.

You may qualify if:

  • Age: 65-85 years old for older individuals and 18-35 years for younger individuals
  • Sex: Men and women
  • BMI: 18-25 kg/m2 for healthy non-obese young and elderly control group and \>30 kg/m2 for obese older participants.
  • Diagnosis / General Health: For healthy elderly, good general health (no known cardiovascular or metabolic disease), nonsmokers, accustomed to normal levels of activity as assessed by pedometer and accelerometer devices during baseline testing (\>5000 steps per day). For obese elderly, general good health (no known cardiovascular or metabolic disease), nonsmokers, with low levels of physical activity as assessed by pedometer and accelerometer devices during baseline testing (\<4000 steps per day). Fasting blood glucose must be \<5.6 mmol/mL for healthy older adults and between 5.6 and 6.9 mmol/mL for obese older adults. Fasting concentrations of A1C should be \<5.7% for healthy and between 5.7 and 6.4% for prediabetic older adults. These values are in line with the type 2 diabetes classification listed by The American Diabetes Association (DIABETES CARE, VOLUME 33, SUPPLEMENT 1, JANUARY 2010).
  • Compliance: understands and is willing, able and likely to comply with all study procedures and restrictions.
  • Consent: demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent.

You may not qualify if:

  • Health problems such as: heart disease, rheumatoid arthritis, diabetes, poor lung function, uncontrolled hypertension, or any health conditions that might put the participant at risk for this study.
  • Recent failure to obtain clearance for exercise participation from family physician/medical doctor.
  • Regular consumption of any analgesic or anti-inflammatory drug(s), prescription or nonprescription.
  • Taking any medications known to affect protein metabolism (i.e. b-blockers, corticosteroids, nonsteroidal anti-inflammatories, or prescription strength acne medications). Medications will be deemed inappropriate based on the Chief Investigators discretion
  • Individuals who complete fewer than 1000 steps per day (as assessed by pedometer prior to the study) or those who participate in regular structured exercise (running or strength training) more than 2 times per week.
  • Participants who have previously (within 5 years of the present study) undergone infusion of an amino acid tracer and/or had 4 or more muscle biopsies obtained from the quadriceps region will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Smeuninx B, Mckendry J, Wilson D, Martin U, Breen L. Age-Related Anabolic Resistance of Myofibrillar Protein Synthesis Is Exacerbated in Obese Inactive Individuals. J Clin Endocrinol Metab. 2017 Sep 1;102(9):3535-3545. doi: 10.1210/jc.2017-00869.

MeSH Terms

Conditions

Muscle WeaknessMotor Activity

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsBehavior

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2017

First Posted

April 13, 2017

Study Start

August 1, 2014

Primary Completion

March 1, 2016

Study Completion

August 1, 2016

Last Updated

April 13, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share