Sarcopenic ObesityNCT06083909
Sarcopenic Obesity in the Elderly
An observational study of Sarcopenic Obesity and Diabetes, run by University of Central Florida at 1 site in United States.
Trial summary
Ageing is associated with progressive and generalized loss of muscle mass and muscle function, also known as Sarcopenia. Increasingly, obesity has become a compounding factor in ageing-related sarcopenia. The coexistence of obesity and sarcopenia is termed sarcopenic obesity (SO). 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, Diabetes
- How many people
- 97 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Apr 2022to 8 May 2023
- 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: The study will include both men and women who are aged 65-85. We plan to recruit a minimum of 25 men and 25 women but no more than 60 of each gender. The maximum sample size is 100. We estimate that less than 10% of the consented participants will not meet the inclusionary criteria and will be withdrawn. As this study involves a solitary study visit, we estimate that less than 5% of the participants will withdraw/be withdrawn/ or be lost to follow up prior to study completion.
Who may be able to join
- This study will include both male and females aged 65-85 years.
Who cannot join
- Lack capacity to consent for the study, or have moderate or severe cognitive impairment;
- Have difficulty ambulating as evidenced by any one of the following:
- Difficulty climbing 10 steps without resting;
- Restricted to a wheelchair
- Have difficulty performing basic activities of daily living;
- Have had treatment for cancer in the prior 3 years;
Show all 14Show fewer
- Have history of cachexia;
- Have a history of heart failure;
- Have a permanent pacemaker in situ (due to magnetic resonance scanning);
- Have an implanted cardioverter-defibrillator (ICD) in situ;
- Have had myocardial infarction within the last 6 months;
- Have any of the following chronic health conditions: peripheral arterial disease prostate cancer, rheumatoid arthritis, autoimmune myositis, chronic obstructive pulmonary disease, and asthma;
- Are receiving therapy with corticosteroids or immunosuppressants.
- Are taking direct insulin sensitizers (PPAR-gamma agonists, or thiazolidinediones).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Central Florida
Orlando, Florida, 32816
About this study
Official title: Sarcopenic Obesity as Risk Factor for Insulin Resistance in the Elderly
Ageing is associated with progressive and generalized loss of muscle mass and muscle function, also known as Sarcopenia. Increasingly, obesity has become a compounding factor in ageing-related sarcopenia. The coexistence of obesity and sarcopenia is termed sarcopenic obesity (SO). Older adults with SO are at higher risks of developing diabetes, hypertension, stroke, cardiovascular diseases, and cognitive dysfunction than those older adults who suffer from sarcopenia alone or obesity alone. However, there is insufficient information with regard to the interplay between obesity and sarcopenia. The primary objective of this study is to investigate the impact of SO on insulin resistance in people aged 65-85. Our hypothesis is that SO positively influences insulin resistance in the elderly. We propose to investigate sarcopenia and obesity as risk factors for insulin resistance in the geriatric (65-85 years old) population.
- Conditions
- Sarcopenic Obesity, Diabetes
- Medical subject headings
- Diabetes Mellitus
What is being measured
The primary outcome is the main question the study is designed to answer.
To explore the correlation of sarcopenia and obesity on insulin resistance
Measured: 2 years
Secondary outcomes (2)
To explore the correlation between muscle strength and memory loss
Measured: 2 years
To explore the correlation of sarcopenic obesity and glucometabolic and cardiovascular risk.
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 posted16 Oct 2023
- Study start6 Apr 2022
- Primary completion19 Apr 2023
- Study completion8 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Central Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muthu Periasamy, PhD, Principal investigator, University of Central FloridaMariana Dangiolo, MD, Principal investigator, University of Central FloridaAli Rizvi, MD, Principal investigator, University of Central Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06083909
- Sponsor's protocol ID
- STUDY00003268
- Status last verified
- Oct 2023
- First submitted
- 9 Oct 2023
- Last updated
- 19 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sarcopenic Obesity as Risk Factor for Insulin Resistance in the Elderly
- ClinicalTrials.gov ID
- NCT06083909
- Acronym / sponsor ID
- STUDY00003268
- Conditions
- Sarcopenic Obesity, Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- University of Central FloridaUniversity, hospital or other
- Study start
- 6 Apr 2022 (actual)
- Primary completion
- 19 Apr 2023 (actual)
- Study completion
- 8 May 2023 (actual)
- First posted
- 16 Oct 2023 (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.
Ageing is associated with progressive and generalized loss of muscle mass and muscle function, also known as Sarcopenia. Increasingly, obesity has become a compounding factor in ageing-related sarcopenia. The coexistence of obesity and sarcopenia is termed sarcopenic obesity (SO). Older adults with SO are at higher risks of developing diabetes, hypertension, stroke, cardiovascular diseases, and cognitive dysfunction than those older adults who suffer from sarcopenia alone or obesity alone. However, there is insufficient information with regard to the interplay between obesity and sarcopenia. The primary objective of this study is to investigate the impact of SO on insulin resistance in people aged 65-85. Our hypothesis is that SO positively influences insulin resistance in the elderly. We propose to investigate sarcopenia and obesity as risk factors for insulin resistance in the geriatric (65-85 years old) population.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- The study will include both men and women who are aged 65-85. We plan to recruit a minimum of 25 men and 25 women but no more than 60 of each gender. The maximum sample size is 100. We estimate that less than 10% of the consented participants will not meet the inclusionary criteria and will be withdrawn. As this study involves a solitary study visit, we estimate that less than 5% of the participants will withdraw/be withdrawn/ or be lost to follow up prior to study completion.
Key inclusion criteria (1 listed)
- This study will include both male and females aged 65-85 years.
Key exclusion criteria (14 listed)
- Lack capacity to consent for the study, or have moderate or severe cognitive impairment;
- Have difficulty ambulating as evidenced by any one of the following:
- Have difficulty performing basic activities of daily living;
- Have had treatment for cancer in the prior 3 years;
- Have history of cachexia;
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
To explore the correlation of sarcopenia and obesity on insulin resistance
Time frame: 2 years
2 secondary outcomes
To explore the correlation between muscle strength and memory loss
Time frame: 2 years
To explore the correlation of sarcopenic obesity and glucometabolic and cardiovascular risk.
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 19 Oct 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.
Muthu Periasamy, PhD principal investigator
University of Central Florida
Mariana Dangiolo, MD principal investigator
University of Central Florida
Ali Rizvi, MD principal investigator
University of Central Florida
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 Sarcopenic Obesity and Diabetes, run by University of Central Florida at 1 site in United States.
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 14 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 Oct 2023. 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 States. 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?
To explore the correlation of sarcopenia and obesity on insulin resistance (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 Oct 2023; AzTrials last refreshed its copy on 28 Oct 2026.