Sarcopenic ObesityNCT03113279
Mechanisms of Age-Related Muscle Loss
An observational study of Sarcopenic Obesity and Muscle Weakness, run by University of Birmingham.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Sarcopenic Obesity, Muscle Weakness, Protein Metabolism Disorder
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2014to 1 Aug 2016
- 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: * Young lean healthy inidivduals aged 18-35. * Lean healthy older individuals aged 65-85. * Obese inactive older individuals aged 65-85.
Who may be able to join
- 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.
Who cannot join
- 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 will be excluded if they fail to comply with the physical activity demands of the study. Exclusion will occur if the following are not met. Failure to meet the expected daily step count target on more than one occasion per week during the 21 day intervention will be deemed as failure to comply.
- 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.
About this study
Official title: Influence of Increasing Physical Activity on Body Composition, Metabolic Health and Muscle Anabolism in Old Obese Adults
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.
Read the detailed description
Twenty healthy young (aged 18-35), healthy old and obese older adults (aged ≥65) will be recruited. Old groups will be matched for age and sexual dimorphism. Obese participants will be classed as prediabetic based on a fasting A1C between 5.7 and 6.4% and impaired fasting glucose between 5.6 and 6.9 mmol/L. Obese participants will habitually take between 2000-5000 steps per day, whilst healthy young and old participants will complete >5000 steps per day.
VISIT 1 Preliminary assessments - Over a 3day period, participants will be instructed to wear a portable pedometer, to allow visual feedback on step count, and an armband accelerometer to determine habitual daily energy expenditure and the intensity of physical activity. In addition, participants will log their dietary intake.
VISIT 2 Body composition and metabolic profiling After consuming a standardized meal the previous evening, participants will report to the Wellcome Trust Clinical Research Facility in a 10 hour fasted state at approximately 09.00. Participants will be weighed in light clothing and blood pressure will be measured. Thereafter, body composition will be determined using dual energy Xray absorptiometry (DXA) and resting metabolic rate (RMR) via ventilated hood and continuous gas collection. Following RMR, a catheter will be inserted into a forearm vein and a resting, fasted blood sample obtained to determine postprandial insulin sensitivity using the HOMA-IR index.
VISIT 3 Muscle protein metabolism Participants will return to the lab in a 10 hour fasted-state at approximately 07.00 having refrained from strenuous exercise for 48 hours previously. Catheters will be inserted into the antecubital vein of both forearms. A primed, continuous infusion of isotopically labeled amino acid will be infused into one arm and the other will be used for frequent blood sampling. Muscle biopsies will be obtained 3 and 7 hours into the infusion to determine postabsorptive and postprandial rates of muscle protein synthesis.
- Medical subject headings
- Muscle Weakness, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Obese older individuals | Obese older individuals | |
| Lean older individuals | Lean older individuals | |
| Young lean individuals | Young lean individuals |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myofibrillar protein synthesis rates via mass spectrometry
Postabsorptive and postprandial myofibrillar protein synthesis rates between groups and following the activity intervention
Measured: 2 years
Secondary outcomes (9)
Muscle fibre properties via immunohistochemical staining
muscle fibre type (i.e. I and II) and cross sectional area
Measured: 2 years
Muscle fibre lipid content immunofluorescent staining
Intramyocellular lipid content in Type I and II fibres
Measured: 2 years
Physical activity levels via accelerometry
Daily average time spent in sedentary, light, moderate or vigorous intensity activity
Measured: 2 years
Inflammation via plasma/insulin assays
Blood markers of inflammation, interleukin 6 and c-reactive protein
Measured: 2 years
Insulin sensitivity via plasma assays
Blood samples will be analyzed for insulin, glucose and hbA1C for indication of whole-body insulin sensitivity
Measured: 2 years
Body composition via dual x-ray absorptiometry
DXA-derived fat and fat free mass will be measured
Measured: 2 years
Intramuscular signaling via western blot
Western blots for phosphorylation of key anabolic signaling proteins
Measured: 2 years
Dietary intake via dietary logs
Diet logs will be assessed for total energy and macronutrient intake
Measured: 2 years
Daily step count by pedometer
Average daily step count assessed via waist worn pedometer
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2017
- Study start1 Aug 2014
- Primary completion1 Mar 2016
- Study completion1 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sarcopenic ObesityStudies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03113279
- Sponsor's protocol ID
- RG-13_183
- Status last verified
- Apr 2017
- First submitted
- 28 Mar 2017
- Last updated
- 13 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28911148
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Increasing Physical Activity on Body Composition, Metabolic Health and Muscle Anabolism in Old Obese Adults
- ClinicalTrials.gov ID
- NCT03113279
- Acronym / sponsor ID
- RG-13_183
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of BirminghamUniversity, hospital or other
- Study start
- 1 Aug 2014 (actual)
- Primary completion
- 1 Mar 2016 (actual)
- Study completion
- 1 Aug 2016 (actual)
- First posted
- 13 Apr 2017 (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.
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.
Detailed description
Twenty healthy young (aged 18-35), healthy old and obese older adults (aged ≥65) will be recruited. Old groups will be matched for age and sexual dimorphism. Obese participants will be classed as prediabetic based on a fasting A1C between 5.7 and 6.4% and impaired fasting glucose between 5.6 and 6.9 mmol/L. Obese participants will habitually take between 2000-5000 steps per day, whilst healthy young and old participants will complete >5000 steps per day.
VISIT 1 Preliminary assessments - Over a 3day period, participants will be instructed to wear a portable pedometer, to allow visual feedback on step count, and an armband accelerometer to determine habitual daily energy expenditure and the intensity of physical activity. In addition, participants will log their dietary intake.
VISIT 2 Body composition and metabolic profiling After consuming a standardized meal the previous evening, participants will report to the Wellcome Trust Clinical Research Facility in a 10 hour fasted state at approximately 09.00. Participants will be weighed in light clothing and blood pressure will be measured. Thereafter, body composition will be determined using dual energy Xray absorptiometry (DXA) and resting metabolic rate (RMR) via ventilated hood and continuous gas collection. Following RMR, a catheter will be inserted into a forearm vein and a resting, fasted blood sample obtained to determine postprandial insulin sensitivity using the HOMA-IR index.
VISIT 3 Muscle protein metabolism Participants will return to the lab in a 10 hour fasted-state at approximately 07.00 having refrained from strenuous exercise for 48 hours previously. Catheters will be inserted into the antecubital vein of both forearms. A primed, continuous infusion of isotopically labeled amino acid will be infused into one arm and the other will be used for frequent blood sampling. Muscle biopsies will be obtained 3 and 7 hours into the infusion to determine postabsorptive and postprandial rates of muscle protein synthesis.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Obese older individuals | – | –Obese older individuals |
| Lean older individuals | – | –Lean older individuals |
| Young lean individuals | – | –Young lean individuals |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- * Young lean healthy inidivduals aged 18-35. * Lean healthy older individuals aged 65-85. * Obese inactive older individuals aged 65-85.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Myofibrillar protein synthesis rates via mass spectrometry
Time frame: 2 years
Postabsorptive and postprandial myofibrillar protein synthesis rates between groups and following the activity intervention
9 secondary outcomes
Muscle fibre properties via immunohistochemical staining
Time frame: 2 years
Muscle fibre lipid content immunofluorescent staining
Time frame: 2 years
Physical activity levels via accelerometry
Time frame: 2 years
Inflammation via plasma/insulin assays
Time frame: 2 years
Insulin sensitivity via plasma assays
Time frame: 2 years
Body composition via dual x-ray absorptiometry
Time frame: 2 years
Intramuscular signaling via western blot
Time frame: 2 years
Dietary intake via dietary logs
Time frame: 2 years
Daily step count by pedometer
Time frame: 2 years
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 13 Apr 2017.
- Derived from this study: PubMed 28911148Smeuninx 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.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcopenic Obesity and Muscle Weakness, run by University of Birmingham.
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 6 inclusion and 7 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 13 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Myofibrillar protein synthesis rates via mass spectrometry (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03113279, which also lists 1 linked publication.
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 13 Apr 2017.