Overweight and ObesitySABONCT05582668
Sarcopenia After Bariatric Surgery in Older Patients: a Cohort Study
An observational study of Overweight and Obesity and Bariatric Surgery, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
The retrospective cohort study will compare the prevalence of sarcopenia and associated factors between older patients who have undergone bariatric surgery and older patients with obesity without previous bariatric surgery. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Overweight and Obesity, Bariatric Surgery, Aging
- What is being tested?
- Bariatric surgery
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- 3 Oct 2022to 14 Jul 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Subjects with overweight, obesity or after bariatric surgery
Who may be able to join
- Signed informed consent
- Age 65 years or older
- Cohort 1 (exposed): Previous bariatric surgery for obesity at least 1 one year ago
- Cohort 2 (unexposed): No previous weight loss surgery
Who cannot join
- Current diagnosis of cancer
- Advanced organ failure, including chronic kidney disease Stage 5, liver cirrhosis Stage 3, intestinal failure, heart failure stage D, or chronic obstructive pulmonary disease stage 4.
- Immobility
- Neuromuscular degenerative conditions
Trial locations and contacts
1 site in 1 country.
About this study
The retrospective cohort study will compare the prevalence of sarcopenia and associated factors between older patients who have undergone bariatric surgery and older patients with obesity without previous bariatric surgery.
Read the detailed description
The aim of the study is to compare the prevalence of sarcopenia and nutritional status between adults older than 65 years who have previously undergone bariatric surgery and patients with obesity but without previous bariatric surgery. Current sarcopenia will be assessed during a cross-sectional assessment after surgery using the criteria from the European Working Group on Sarcopenia in Older People (EWGSOP).
- Conditions
- Overweight and Obesity, Bariatric Surgery, Aging, Sarcopenic Obesity
- Being tested
- Bariatric surgery
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bariatric surgeryProcedure or surgery
Bariatric surgery
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Cohort 1: Older patients with overweight, obesity after bariatric surgery Receives: Procedure: Bariatric surgery | |
| Cohort 2 | Cohort 2: Older patients with overweight, obesity without bariatric surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of older patients with sarcopenia after bariatric surgery compared to non-surgical control patients.
- Sarcopenia will be classified according to the criteria form the European Working Group on Sarcopenia in Older People revised guidelines (EWGSOP2) based on skeletal muscle mass, muscle strength and physical performance criteria.
Measured: At least one year post surgery
Secondary outcomes (3)
1. Appendicular skeletal muscle mass older of patients after bariatric surgery compared to non-surgical control patients
- Appendicular skeletal muscle mass older of patients after bariatric surgery compared to non-surgical control patients
Measured: At least one year post surgery
2. The prevalence of nutrient deficiencies in older patients after bariatric surgery compared to non-surgical control patients.
- Indices of nutrient deficiencies will include reported dietary intake of protein, zinc, selenium, and blood levels of Vitamin D, zinc, and selenium.
Measured: At least one year post surgery
3. Markers of chronic systemic inflammation in older patients after bariatric surgery compared to non-surgical control patients
Inflammatory markers will include CRP, IL-1β, IL-6, IL-8, TNF-α
Measured: At least one year post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2022
- Study start3 Oct 2022
- Primary completion14 Jul 2024
- Study completion14 Jul 2024
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 Overweight and ObesityStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05582668
- Sponsor's protocol ID
- S66815
- Acronym
- SABO
- Status last verified
- Oct 2024
- First submitted
- 12 Oct 2022
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Eksteen G, Vanuytsel T, Vangoitsenhoven R, Mertens A, Lannoo M, De Leus E, Van der Schueren B, Matthys C. Sarcopenia, Muscle Mass and Protein Intake in Adults Older Than 65 Years After Earlier Bariatric Surgery. J Cachexia Sarcopenia Muscle. 2025 Jun;16(3):e13839. doi: 10.1002/jcsm.13839.
PubMed 40468919
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sarcopenia After Bariatric Surgery in Older Patients: a Cohort Study
- ClinicalTrials.gov ID
- NCT05582668
- Acronym / sponsor ID
- SABO / S66815
- Conditions
- Overweight and Obesity, Bariatric Surgery, Aging, Sarcopenic Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 3 Oct 2022 (actual)
- Primary completion
- 14 Jul 2024 (actual)
- Study completion
- 14 Jul 2024 (actual)
- First posted
- 17 Oct 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.
The retrospective cohort study will compare the prevalence of sarcopenia and associated factors between older patients who have undergone bariatric surgery and older patients with obesity without previous bariatric surgery.
Detailed description
The aim of the study is to compare the prevalence of sarcopenia and nutritional status between adults older than 65 years who have previously undergone bariatric surgery and patients with obesity but without previous bariatric surgery. Current sarcopenia will be assessed during a cross-sectional assessment after surgery using the criteria from the European Working Group on Sarcopenia in Older People (EWGSOP).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Procedure: Bariatric surgeryCohort 1: Older patients with overweight, obesity after bariatric surgery |
| Cohort 2 | – | –Cohort 2: Older patients with overweight, obesity without bariatric surgery |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Subjects with overweight, obesity or after bariatric surgery
Key inclusion criteria (4 listed)
- Signed informed consent
- Age 65 years or older
- Cohort 1 (exposed): Previous bariatric surgery for obesity at least 1 one year ago
- Cohort 2 (unexposed): No previous weight loss surgery
Key exclusion criteria (4 listed)
- Current diagnosis of cancer
- Advanced organ failure, including chronic kidney disease Stage 5, liver cirrhosis Stage 3, intestinal failure, heart failure stage D, or chronic obstructive pulmonary disease stage 4.
- Immobility
- Neuromuscular degenerative conditions
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 |
|---|---|---|
| Bariatric surgeryBariatric surgery | Procedure or surgery | Cohort 1 |
Primary outcome
The number of older patients with sarcopenia after bariatric surgery compared to non-surgical control patients.
Time frame: At least one year post surgery
a) Sarcopenia will be classified according to the criteria form the European Working Group on Sarcopenia in Older People revised guidelines (EWGSOP2) based on skeletal muscle mass, muscle strength and physical performance criteria.
3 secondary outcomes
1. Appendicular skeletal muscle mass older of patients after bariatric surgery compared to non-surgical control patients
Time frame: At least one year post surgery
2. The prevalence of nutrient deficiencies in older patients after bariatric surgery compared to non-surgical control patients.
Time frame: At least one year post surgery
3. Markers of chronic systemic inflammation in older patients after bariatric surgery compared to non-surgical control patients
Time frame: At least one year post surgery
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 25 Feb 2025.
- Derived from this study: PubMed 40468919Eksteen G, Vanuytsel T, Vangoitsenhoven R, Mertens A, Lannoo M, De Leus E, Van der Schueren B, Matthys C. Sarcopenia, Muscle Mass and Protein Intake in Adults Older Than 65 Years After Earlier Bariatric Surgery. J Cachexia Sarcopenia Muscle. 2025 Jun;16(3):e13839. doi: 10.1002/jcsm.13839.
- 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.
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 Overweight and Obesity and Bariatric Surgery, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 4 inclusion and 4 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 25 Feb 2025. 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 Belgium. 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?
The number of older patients with sarcopenia after bariatric surgery compared to non-surgical control patients. (time frame: At least one year post surgery). 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 NCT05582668, 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 25 Feb 2025.