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Impact GLP-1 Agonists Following Bariatric
Biometabolic Impact of Continuation of GLP-1 Agonists Following Bariatric
Lead sponsor
Assets
GLP-1 / incretin class catch-all / Semaglutide
Listed sites
1
Recruiting sites
1
Enrollment
150
estimated
Study population
Bariatric Surgery, Obesity / overweight
Key I/E criterion
•BMI 30-80
Primary endpoints
•BMI, change•Effect of GLP1-RA on circulating bile acids and metabolites•Effector of GLP1-RA on gut microbiome diversity
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
1. Greater than 18 years of age
2. Participation in care by one of the surgeons at MU Health Care
3. Undergoing surgical weight loss through the Weight Management and Metabolic Center
4. Body mass index of 30-80 kg/m2
5. Meet insurance criteria, as set forth by the patient's insurance policy, to qualify for coverage for weight loss surgery or as a self-pay patient for the weight loss procedure
6. Planned laparoscopic Roux-en-Y gastric bypass, sleeve gastrectomy, revisional weight loss surgery, or duodenal switch or modification of. If patients are not willing to be randomized they will not be enrolled as randomized but can still participate having samples collected.
7. Willingness to have blood collected before and after surgical procedure at defined points or at minimum have clinical data collected.
8. Willingness to have clinical data entered into a prospective database
9. Additional specimens collected as stated in the protocol will be offered but collection not mandated.
5. Taking a GLP-1 agonist as part of their routine medical care apart from any planned surgical procedure. The current standard of care regarding continuation or discontinuation of GLP-1 agonists has not been established and is at the discretion of members of the patient's medical team but to be included the patient and medical care team must be willing to continue or discontinue the GLP-1 agonist after surgery depending on the randomized group.
Exclusion criteria
1. Pregnant patient
2. Desire to not participate
3. Age less than 18
4. Patient fails to fulfill insurance mandated criteria and is not interested in paying cash for their procedure
5. Not taking a GLP-1 agonist as part of standard medical care
6. Unwilling to follow-up at required postoperative visits
7. Unwilling to stop GLP-1 agonist if randomized into group to stop GLP-1 agonist or unwilling to continue the GLP-1 agonist if randomized into that respective group. If chooses to continue or discontinue the medication apart from randomization the patient can still participate as a non-randomized participant
Endpoints (5)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Weight & body composition
1 endpointEffect of GLP1-RA on weight loss
Time frame:6 months
BMI, change
change from baseline, improvement
Glycemic / diabetes
1 endpointEffect of GLP1-RA on Glycemic control
Time frame:6 months
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Patient-reported / QoL
1 endpointEffect of GLP1-RA on satiety and hunger
Time frame:6 months
change from baseline, improvement
Other (unclassified)
2 endpointsEffect of GLP1-RA on circulating bile acids and metabolites
Time frame:6 months
descriptive
Effector of GLP1-RA on gut microbiome diversity
Time frame:6 months
descriptive
Publications (37)
Bibliography
Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.
Registry references + supporting bibliography
- Arquivos brasileiros de cirurgia digestiva : ABCD = Brazilian archives of digestive surgery2022 (year)PMID36542005doi:10.1590/0102-672020220002e1707via CT.gov background
- Cardiovascular diabetology2021 Dec 17PMID34920733doi:10.1186/s12933-021-01431-2via CT.gov background
- Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists2021 Jun (month)PMID34016530doi:10.1016/j.eprac.2020.12.014via CT.gov background
- Gastroenterology clinics of North America2021 Mar (month)PMID33518159doi:10.1016/j.gtc.2020.10.005via CT.gov background
- Journal of trace elements in medicine and biology : organ of the Society for Minerals and Trace Elements (GMS)2020 Dec (month)PMID33011630doi:10.1016/j.jtemb.2020.126650via CT.gov background
- Journal of endocrinological investigation2019 Feb (month)PMID29730732doi:10.1007/s40618-018-0892-2via CT.gov background
- Surgery for obesity and related diseases : official journal of the American Society for Bariatric Surgery2018 May (month)PMID29551470doi:10.1016/j.soard.2018.01.011via CT.gov background
- The Journal of experimental medicine2018 Feb 5PMID29339445doi:10.1084/jem.20171965via CT.gov background
- Diabetes, obesity & metabolism2017 Sep (month)PMID28266779doi:10.1111/dom.12932via CT.gov background
- The New England journal of medicine2017 Apr 13PMID28406283doi:10.1056/NEJMc1701944via CT.gov background
- Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists2016 Jul (month)PMID27219496doi:10.4158/EP161365.GLvia CT.gov background
- Diabetes, obesity & metabolism2016 Apr (month)PMID26511102doi:10.1111/dom.12596via CT.gov background
- The New England journal of medicine2014 May 22PMID24679060doi:10.1056/NEJMoa1401329via CT.gov background
- International journal of obesity (2005)2012 Jun (month)PMID21844879doi:10.1038/ijo.2011.158via CT.gov background
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.