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

October 18, 2022 updated by: Universitaire Ziekenhuizen KU Leuven
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • Recruiting
        • Obesity Clinic University Hospitals Leuven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects with overweight, obesity or after bariatric surgery

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At least one year post surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1. Appendicular skeletal muscle mass older of patients after bariatric surgery compared to non-surgical control patients
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
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
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
At least one year post surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 3, 2022

Primary Completion (ANTICIPATED)

October 31, 2024

Study Completion (ANTICIPATED)

October 31, 2024

Study Registration Dates

First Submitted

October 12, 2022

First Submitted That Met QC Criteria

October 12, 2022

First Posted (ACTUAL)

October 17, 2022

Study Record Updates

Last Update Posted (ACTUAL)

October 21, 2022

Last Update Submitted That Met QC Criteria

October 18, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S66815

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Aging

Clinical Trials on Bariatric surgery

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Brazil

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe