NCT05582668

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 3, 2022

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

October 12, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 17, 2022

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 14, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 14, 2024

Completed
Last Updated

February 25, 2025

Status Verified

October 1, 2024

Enrollment Period

1.8 years

First QC Date

October 12, 2022

Last Update Submit

February 21, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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.

    At least one year post surgery

  • 3. Markers of chronic systemic inflammation in older patients after bariatric surgery compared to non-surgical control patients

    At least one year post surgery

Study Arms (2)

Cohort 1

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

Procedure: Bariatric surgery

Cohort 2

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

Interventions

Bariatric surgery

Cohort 1

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects with overweight, obesity or after bariatric surgery

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Obesity Clinic University Hospitals Leuven

Leuven, 3000, Belgium

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

OverweightObesity

Interventions

Bariatric Surgery

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BariatricsObesity ManagementTherapeuticsSurgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2022

First Posted

October 17, 2022

Study Start

October 3, 2022

Primary Completion

July 14, 2024

Study Completion

July 14, 2024

Last Updated

February 25, 2025

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations