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NCT Number: NCT05582668

Sarcopenia After Bariatric Surgery in Older Patients: a Cohort 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.

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Key information

Conditions

Overweight and Obesity Aging Bariatric Surgery Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Sarcopenic Obesity Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Obesity Clinic University Hospitals Leuven

Leuven, 3000, Belgium

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bariatric surgery

Procedure

Bariatric surgery

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

    • Appendicular skeletal muscle mass older of patients after bariatric surgery compared to non-surgical control patients

  2. 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

    a. Indices of nutrient deficiencies will include reported dietary intake of protein, zinc, selenium, and blood levels of Vitamin D, zinc, and selenium.

  3. 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

    Inflammatory markers will include CRP, IL-1β, IL-6, IL-8, TNF-α

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Acronym: SABO

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Oct 17, 2022
Registry last updated
Feb 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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