SarcopeniaNCT02426073
Glucose Metabolism, Muscle Mass/Function and Inflammation in the Elderly
An observational study of Sarcopenia and Diabetes Mellitus, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 2 sites in Italy.
Trial summary
A thorough characterization of glucose metabolism and "inflammaging" in elderly subjects will help determine to what extent each of these factors affects muscle mass/function and contributes to age-related muscle wasting. Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia, Diabetes Mellitus
- How many people
- 76 participants
- Where
- 2 sitesItaly
- Study dates
- Jan 2017to Feb 2022
- 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 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Elderly (≥ 70 years) subjects
Who may be able to join
- Type 2 diabetes mellitus: patients taking drugs for diabetes will be diagnosed as having diabetes. In all other patients, a diagnosis will be established according to the criteria of the American Diabetes Association
- Sarcopenia (non-severe): individuals with low muscle mass and either low muscle strength or low physical performance will be diagnosed with sarcopenia, according to the criteria of the European Working Group on Sarcopenia in Older People (EWGSOP)
- Healthy volunteers: no diabetes, no sarcopenia and none of the exclusion criteria
Who cannot join
- acute diseases,
- chronic obstructive pulmonary disease (COPD)
- conditions associated with sarcopenia/altered body composition (e.g. disability, altered endocrine function, chronic diseases, nutritional deficiencies, cancer),
- obesity (body mass index ≥30 kg/m2)
- moderate-severe hepatic disease,
- chronic kidney disease (estimated glomerular filtration rate <30 ml/min per 1.73m2),
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- metal prostheses,
- recent or ongoing infection,
- inability or unwillingness to provide informed consent
- type 1 diabetes,
- hemoglobin A1c >8.5% (69 mmol/mol),
- basal-bolus insulin therapy,
- insulin pump therapy,
- proliferative diabetic retinopathy,
- diabetic foot.
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Catholic University of Sacred Heart
Rome, 00168
Ospedale San Giovanni Calibita - Fatebenefratelli Isola Tiberina
Rome, 00186
About this study
Official title: Pilot Observational Study to Characterize Glucose Metabolism, Muscle Mass/Function and Inflammatory Profile in Elderly Individuals
A thorough characterization of glucose metabolism and "inflammaging" in elderly subjects will help determine to what extent each of these factors affects muscle mass/function and contributes to age-related muscle wasting. The investigators will correlate patterns of insulin secretion/sensitivity with "muscle "quality/quantity" in diabetic and non-diabetic elderlies (≥70 years old). By comparing different groups (healthy, sarcopenic, diabetic, diabetic/sarcopenic), the investigators expect to identify an "oxidative/inflammatory signature" (e.g., circulating interleukins/myokines, plasma antioxidant capacity) specific for the sarcopenic phenotype and related to muscle insulin resistance.
- Conditions
- Sarcopenia, Diabetes Mellitus
- Keywords
- Inflammaging
- Medical subject headings
- Sarcopenia, Diabetes Mellitus
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 |
|---|---|---|
| HE | Healthy elderlies | |
| DM | Elderlies with type 2 diabetes | |
| SA | Elderlies with sarcopenia | |
| DS | Elderlies with both type 2 diabetes and sarcopenia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammatory markers (TNF-α, interleukin-1, interleukin-2, interleukin-6, RANKL, Myostatin and GDF11)
The primary objective of the study is to detect differences in inflammatory markers in the four groups
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 posted24 Apr 2015 (estimated)
- Study startJan 2017
- Primary completionFeb 2022
- Study completionFeb 2022
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 Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- University of Rome Tor Vergata, Fondazione Roma
- Responsible party
- Principal investigator, Giaccari Andrea, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02426073
- Sponsor's protocol ID
- 5312/15
- Status last verified
- Apr 2023
- First submitted
- 21 Apr 2015
- Last updated
- 19 Apr 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Observational Study to Characterize Glucose Metabolism, Muscle Mass/Function and Inflammatory Profile in Elderly Individuals
- ClinicalTrials.gov ID
- NCT02426073
- Acronym / sponsor ID
- 5312/15
- Conditions
- Sarcopenia, Diabetes Mellitus
- Keywords
- Inflammaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Collaborators
- University of Rome Tor Vergata, Fondazione Roma
- Study start
- Jan 2017 (actual)
- Primary completion
- Feb 2022 (actual)
- Study completion
- Feb 2022 (actual)
- First posted
- 24 Apr 2015 (estimated)
- 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.
A thorough characterization of glucose metabolism and "inflammaging" in elderly subjects will help determine to what extent each of these factors affects muscle mass/function and contributes to age-related muscle wasting. The investigators will correlate patterns of insulin secretion/sensitivity with "muscle "quality/quantity" in diabetic and non-diabetic elderlies (≥70 years old). By comparing different groups (healthy, sarcopenic, diabetic, diabetic/sarcopenic), the investigators expect to identify an "oxidative/inflammatory signature" (e.g., circulating interleukins/myokines, plasma antioxidant capacity) specific for the sarcopenic phenotype and related to muscle insulin resistance.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HE | – | –Healthy elderlies |
| DM | – | –Elderlies with type 2 diabetes |
| SA | – | –Elderlies with sarcopenia |
| DS | – | –Elderlies with both type 2 diabetes and sarcopenia |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Elderly (≥ 70 years) subjects
Key inclusion criteria (3 listed)
- Type 2 diabetes mellitus: patients taking drugs for diabetes will be diagnosed as having diabetes. In all other patients, a diagnosis will be established according to the criteria of the American Diabetes Association
- Sarcopenia (non-severe): individuals with low muscle mass and either low muscle strength or low physical performance will be diagnosed with sarcopenia, according to the criteria of the European Working Group on Sarcopenia in Older People (EWGSOP)
- Healthy volunteers: no diabetes, no sarcopenia and none of the exclusion criteria
Key exclusion criteria (15 listed)
- acute diseases,
- chronic obstructive pulmonary disease (COPD)
- conditions associated with sarcopenia/altered body composition (e.g. disability, altered endocrine function, chronic diseases, nutritional deficiencies, cancer),
- obesity (body mass index ≥30 kg/m2)
- moderate-severe hepatic disease,
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
Inflammatory markers (TNF-α, interleukin-1, interleukin-2, interleukin-6, RANKL, Myostatin and GDF11)
Time frame: 2 years
The primary objective of the study is to detect differences in inflammatory markers in the four groups
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 19 Apr 2023.
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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.
2 sites 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 Diabetes Mellitus, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 2 sites in Italy.
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 3 inclusion and 15 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 19 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. 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?
Inflammatory markers (TNF-α, interleukin-1, interleukin-2, interleukin-6, RANKL, Myostatin and GDF11) (time frame: 2 years). 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 19 Apr 2023.