SABO: Sarcopenia After Bariatric Surgery in Older Patients: A Cohort Study

Sponsor
Universitaire Ziekenhuizen KU Leuven (Other)
Overall Status
Recruiting
CT.gov ID
NCT05582668
Collaborator
(none)
100
1
24.9
4

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: 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

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Sarcopenia After Bariatric Surgery in Older Patients: A Cohort Study
Actual Study Start Date :
Oct 3, 2022
Anticipated Primary Completion Date :
Oct 31, 2024
Anticipated Study Completion Date :
Oct 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Cohort 1

Cohort 1: Older patients with overweight, obesity after bariatric surgery

Procedure: Bariatric surgery
Bariatric surgery

Cohort 2

Cohort 2: Older patients with overweight, obesity without bariatric surgery

Outcome Measures

Primary Outcome Measures

  1. The number of older patients with sarcopenia after bariatric surgery compared to non-surgical control patients. [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 Outcome Measures

  1. 1. Appendicular skeletal muscle mass older of patients after bariatric surgery compared to non-surgical control patients [At least one year post surgery]

    1. 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. [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 [At least one year post surgery]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Obesity Clinic University Hospitals Leuven Leuven Belgium 3000

Sponsors and Collaborators

  • Universitaire Ziekenhuizen KU Leuven

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Universitaire Ziekenhuizen KU Leuven
ClinicalTrials.gov Identifier:
NCT05582668
Other Study ID Numbers:
  • S66815
First Posted:
Oct 17, 2022
Last Update Posted:
Oct 21, 2022
Last Verified:
Oct 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 21, 2022