ObesitySARCOBEAGINGNCT05443711
Sarcopenic Obesity as a Risk of Premature Aging
An observational study of Obesity and Sarcopenic Obesity, run by Hospital de Leon at 1 site in Spain.
Trial summary
Recently, numerous signaling proteins derived from adipose tissue and/or skeletal muscle have been described and are involved in the pathogenesis of obesity and the pathophysiology of aging. Read more about this study
- Who is it for?
- Ages 50 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Sarcopenic Obesity, Aging
- How many people
- 75 participants
- Where
- 1 siteSpain
- Study dates
- 19 Jan 2022to 31 Dec 2024
- 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 50 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: People, men and postmenopausal women, aged between 50 and 60 years. Diagnosis of central obesity with body mass index greater than or equal to 30 kg/m2 and waist circumference equal to or greater than 102 cm in men and 88 cm in women.
Who may be able to join
- People, men and postmenopausal women, aged between 50 and 60 years. Diagnosis of central obesity with body mass index greater than or equal to 30 kg/m2 and waist circumference equal to or greater than 102 cm in men and 88 cm in women.
- Control group, of healthy individuals with BMI less than 30 kg/m2 and waist circumference <102 cm in men and <88 cm in women, of the same age group and matched according to gender.
- Able of giving informed consent.
Who cannot join
- Premenopausal women. Kidney disease with glomerular filtration rate less than 60. Liver disease with plasma GOT/GPT/GGT levels greater than x 2 the upper limit of normal.
- Active cancer disease. Heart or respiratory failure requiring pharmacological treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SARCOBEAGING: Sarcopenic Obesity as a Risk of Premature Aging
Recently, numerous signaling proteins derived from adipose tissue and/or skeletal muscle have been described and are involved in the pathogenesis of obesity and the pathophysiology of aging. Current evidence suggests a role for the FGF-Klotho system, circulating cell-free DNA (cfDNA), miR-499, and exosomes not only in the pathophysiology of obesity, but also in the association with sarcopenic obesity (OS) and in a accelerated aging.
The investigator´s hypothesis is that obesity, especially OS, might be the cause of advanced aging, reflected in lower levels of the FGF-Klotho system, higher concentrations of cfDNA and a change in the profiles of miRNAs and exosomes, which could have an impact on risk. cardiovascular and metabolic.
Read more
For this, a descriptive cross-sectional study is proposed in 50 patients with obesity, who will be classified as OS or not, and 25 healthy controls, between 50-60 years old. The determinations are made by the IBIOMED of the University of León.
To study the evolution of aging markers over a year of follow-up, a second part of the study will analyze the possible differences according to the treatments assigned to each patient in the context of real life (lifestyle changes, drugs, bariatric surgery).
Read the detailed description
Descriptive cross-sectional study in patients with obesity attended in the High-Risk Obesity consultation of the University Assistance Complex of León, with a control group of healthy people of the same age group without obesity or cardiovascular risk factors that will be selected among volunteers from the CAULE and University of Leon staff.
The second part of the study will be a one-year prospective longitudinal follow-up study of the patients included in the first part of the study.
- Conditions
- Obesity, Sarcopenic Obesity, Aging
- Being tested
- No intervention, observational study
- Keywords
- obesity, sarcopenia, aging, klotho, miRNA
- Medical subject headings
- Obesity, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention, observational studyOther
No intervention, observational study
| Study group | Role | What they receive |
|---|---|---|
| obesity | Patients with obesity attended in the High-Risk Obesity clinic of the Complejo ASistencial Universitario de León, 50-60 years-old Receives: Other: No intervention, observational study | |
| control | control group of healthy people of the same age group without obesity or cardiovascular risk factors that will be selected among volunteers from the CAULE staff. and University of Leon Receives: Other: No intervention, observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
S-Klotho levels
Measured: 2022-2023
miR-499
Blood samples
Measured: 2022-2023
cfDNA
Blood samples
Measured: 2022-2023
Exosomes
Blood samples
Measured: 2022-2023
Secondary outcomes (4)
Fat mass
DXA
Measured: 2022-2023
Muscle mass
DXA
Measured: 2022-2023
Muscle function
Hand grip strength
Measured: 2022-2023
Muscle function 2
Strenght platform
Measured: 2022-2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2022
- Study start19 Jan 2022
- Primary completion5 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Prospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Leon
- Sponsor type
- Other government
- Collaborators
- Universidad de León
- Responsible party
- Principal investigator, Maria D. Ballesteros Pomar, Hospital de Leon
- Investigators
- Maria D Ballesteros Pomar, PhD, Study director, Complejo Asistencial Universitario de León
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05443711
- Sponsor's protocol ID
- CAULE 21125
- Other IDs
- GRS 2326/A/21
- Acronym
- SARCOBEAGING
- Status last verified
- Feb 2024
- First submitted
- 29 Jun 2022
- Last updated
- 29 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SARCOBEAGING: Sarcopenic Obesity as a Risk of Premature Aging
- ClinicalTrials.gov ID
- NCT05443711
- Acronym / sponsor ID
- SARCOBEAGING / CAULE 21125
- Conditions
- Obesity, Sarcopenic Obesity, Aging
- Keywords
- obesity, sarcopenia, aging, klotho, miRNA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Hospital de LeonOther government
- Collaborators
- Universidad de León
- Study start
- 19 Jan 2022 (actual)
- Primary completion
- 5 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 5 Jul 2022 (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.
Recently, numerous signaling proteins derived from adipose tissue and/or skeletal muscle have been described and are involved in the pathogenesis of obesity and the pathophysiology of aging. Current evidence suggests a role for the FGF-Klotho system, circulating cell-free DNA (cfDNA), miR-499, and exosomes not only in the pathophysiology of obesity, but also in the association with sarcopenic obesity (OS) and in a accelerated aging.
The investigator´s hypothesis is that obesity, especially OS, might be the cause of advanced aging, reflected in lower levels of the FGF-Klotho system, higher concentrations of cfDNA and a change in the profiles of miRNAs and exosomes, which could have an impact on risk. cardiovascular and metabolic.
For this, a descriptive cross-sectional study is proposed in 50 patients with obesity, who will be classified as OS or not, and 25 healthy controls, between 50-60 years old. The determinations are made by the IBIOMED of the University of León.
To study the evolution of aging markers over a year of follow-up, a second part of the study will analyze the possible differences according to the treatments assigned to each patient in the context of real life (lifestyle changes, drugs, bariatric surgery).
Detailed description
Descriptive cross-sectional study in patients with obesity attended in the High-Risk Obesity consultation of the University Assistance Complex of León, with a control group of healthy people of the same age group without obesity or cardiovascular risk factors that will be selected among volunteers from the CAULE and University of Leon staff.
The second part of the study will be a one-year prospective longitudinal follow-up study of the patients included in the first part of the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| obesity | – | Other: No intervention, observational studyPatients with obesity attended in the High-Risk Obesity clinic of the Complejo ASistencial Universitario de León, 50-60 years-old |
| control | – | Other: No intervention, observational studycontrol group of healthy people of the same age group without obesity or cardiovascular risk factors that will be selected among volunteers from the CAULE staff. and University of Leon |
Who may qualify
- Ages
- 50 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- People, men and postmenopausal women, aged between 50 and 60 years. Diagnosis of central obesity with body mass index greater than or equal to 30 kg/m2 and waist circumference equal to or greater than 102 cm in men and 88 cm in women.
Key inclusion criteria (3 listed)
- People, men and postmenopausal women, aged between 50 and 60 years. Diagnosis of central obesity with body mass index greater than or equal to 30 kg/m2 and waist circumference equal to or greater than 102 cm in men and 88 cm in women.
- Control group, of healthy individuals with BMI less than 30 kg/m2 and waist circumference <102 cm in men and <88 cm in women, of the same age group and matched according to gender.
- Able of giving informed consent.
Key exclusion criteria (2 listed)
- Premenopausal women. Kidney disease with glomerular filtration rate less than 60. Liver disease with plasma GOT/GPT/GGT levels greater than x 2 the upper limit of normal.
- Active cancer disease. Heart or respiratory failure requiring pharmacological treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention, observational studyNo intervention, observational study | Other | control, obesity |
Primary outcome
S-Klotho levels
Time frame: 2022-2023
miR-499
Time frame: 2022-2023
Blood samples
cfDNA
Time frame: 2022-2023
Blood samples
Exosomes
Time frame: 2022-2023
Blood samples
4 secondary outcomes
Fat mass
Time frame: 2022-2023
Muscle mass
Time frame: 2022-2023
Muscle function
Time frame: 2022-2023
Muscle function 2
Time frame: 2022-2023
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
- 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.
Maria D Ballesteros Pomar, PhD study director
Complejo Asistencial Universitario de León
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 Obesity and Sarcopenic Obesity, run by Hospital de Leon at 1 site in Spain.
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 2 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: status not confirmed, as of the sponsor's last update on 29 Feb 2024. 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 Spain. 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?
Results are not available in the source record.
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?
S-Klotho levels (time frame: 2022-2023). The study lists 4 primary outcomes in all. 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 29 Feb 2024.