- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06076187
The Proportion of Dietary Protein Digested as Measured by the Dual-isotope Method.
October 6, 2023 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
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 (Estimated)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Nele Steenackers
- Phone Number: +16344913
- Email: nele.steenackers@kuleuven.be
Study Contact Backup
- Name: Bart Van der Schueren
Study Locations
-
-
Vlaams Brabant
-
Leuven, Vlaams Brabant, Belgium, 3000
- Recruiting
- UZLeuven
-
Contact:
- Gabriel Eksteen, MSc
- Phone Number: 003249392117
- Email: gabrieljohannes.eksteen@kuleuven.be
-
-
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
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
Study Population
Subjects with overweight, obesity or after bariatric surgery
Description
Inclusion Criteria:
- Signed informed consent
- Age 65 years or older
- Group 1 & 2: Previous bariatric surgery for obesity 1 - 10 years ago
- Group 3: 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
- Gastrointestinal conditions including coeliac disease, Crohn's disease, previous resection of the small intestine, gastroparesis
- Unable to follow the procedures of the studies due to cognitive impairment such as diagnosed dementia.
- Allergy/intolerance to milk, or soy or spirulina
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 |
---|---|
Group 1: Patients over 65 years of age who had undergone Roux-en-Y bariatric surgery
|
Dual isotope method
|
Group 2: Patients over 65 years of age who had undergone sleeve gastrectomy surgery
|
Dual isotope method
|
Group 3: Patients over 65 years of age without previous bariatric surgery
|
Dual isotope method
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The proportion of dietary protein digested as measured by the dual-isotope method.
Time Frame: 3,5 hours
|
The proportion of dietary protein digested as measured by the dual-isotope method.
|
3,5 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
May 1, 2023
Primary Completion (Estimated)
May 1, 2024
Study Completion (Estimated)
May 1, 2024
Study Registration Dates
First Submitted
April 12, 2023
First Submitted That Met QC Criteria
October 6, 2023
First Posted (Estimated)
October 10, 2023
Study Record Updates
Last Update Posted (Estimated)
October 10, 2023
Last Update Submitted That Met QC Criteria
October 6, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- S67116
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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.
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