Sarcopenia After Bariatric Surgery in Older Patients: A Cohort Study

Aging Clinical Trial

— SABO  

Official title:

Sarcopenia After Bariatric Surgery in Older Patients: A Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05582668
• Other study ID #: S66815
• Status: Recruiting
• Start date: October 3, 2022
• Est. completion date: October 31, 2024

Study information

• Verified date: October 2022
• Source: Universitaire Ziekenhuizen KU Leuven
• Contact: Bart Van der Schueren, MD, PhD
• Phone: +3216346994
• Email: bart.vanderschueren[@]uzleuven.be
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Aging
• Bariatric Surgery
• Obesity
• Overweight
• Overweight and Obesity
• Sarcopenia
• Sarcopenic Obesity

Intervention

Procedure:
• Bariatric surgery
Bariatric surgery

Locations

Country	Name	City	State
Belgium	Obesity Clinic University Hospitals Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of older patients with sarcopenia after bariatric surgery compared to non-surgical control patients.	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.	At least one year post surgery
Secondary	1. Appendicular skeletal muscle mass older of patients after bariatric surgery compared to non-surgical control patients	1. Appendicular skeletal muscle mass older of patients after bariatric surgery compared to non-surgical control patients	At least one year post surgery
Secondary	2. The prevalence of nutrient deficiencies in older patients after bariatric surgery compared to non-surgical control patients.	a. Indices of nutrient deficiencies will include reported dietary intake of protein, zinc, selenium, and blood levels of Vitamin D, zinc, and selenium.	At least one year post surgery
Secondary	3. Markers of chronic systemic inflammation in older patients after bariatric surgery compared to non-surgical control patients	Inflammatory markers will include CRP, IL-1ß, IL-6, IL-8, TNF-a	At least one year post surgery