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Impact GLP-1 Agonists Following Bariatric Fase IV 150 Microbioma Randomizzato

In arruolamento
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La sperimentazione clinica NCT06132477 è uno studio interventistico di Fase IV volto a esaminare il trattamento per Obesità grave, Sindrome metabolica, Diabete mellito, Ipertensione, Apnea ostruttiva del sonno nell'adulto, attualmente in arruolamento. Avviato il 1 febbraio 2024, prevede di arruolare 150 partecipanti. Sotto la guida di l'Università del Missouri-Columbia, dovrebbe concludersi entro il 1 luglio 2030. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 22 gennaio 2026.
Sommario breve
Glucagon-like peptide 1 (GLP-1) is a hormone that helps regulate blood glucose levels through improved insulin sensitivity and release of insulin from the pancreas, control hunger, induce satiety and plays a role in the metabolic health of a person. GLP-1 receptor agonists (GLP1-RAs) have been shown to be effective in achieving weight loss in patients with type 2 diabetes while improving blood glucose control. Bariat...Mostra di più
Descrizione dettagliata
Preliminary Work To date we have established a randomized controlled clinical trial where we are comparing groups of patients with variable lengths of biliopancreatic limb lengths during gastric bypass. VSG patients serve as a control surgical group, and we have gathered both serum and stool in over 200 patients. We have collaborated with both the institutional metagenomics and proteomics centers to process samples a...Mostra di più
Titolo ufficiale

Biometabolic Impact of Continuation of GLP-1 Agonists Following Bariatric

Patologie
Obesità graveSindrome metabolicaDiabete mellitoIpertensioneApnea ostruttiva del sonno nell'adulto
Pubblicazioni
Articoli scientifici e documenti di ricerca pubblicati su questo studio clinico:
Altri ID dello studio
  • 2098885
Numero NCT
NCT06132477
Data di inizio (effettiva)
2024-02-01
Ultimo aggiornamento pubblicato
2026-01-22
Data di completamento (stimata)
2030-07
Arruolamento (previsto)
150
Tipo di studio
Interventistico
FASE
Fase IV
Stato
In arruolamento
Parole chiave
glp-1 agonist
Morbid Obesity
Bariatric Surgery
Metabolic syndrome
Diabetes Mellitus
Hypertension
Obstructive Sleep Apnea
Scopo principale
Trattamento
Allocazione
Randomizzato
Modello di intervento
Studio incrociato
Mascheramento
Nessuno (studio in aperto)
Bracci / Interventi
Gruppo/Braccio di partecipantiIntervento/Trattamento
Comparatore attivoGLP-1 Agonist Group
This cohort will consist of patients undergoing bariatric surgery who are currently receiving a GLP-1 Agonists for weight loss and/or diabetes management, that will be maintained on their preoperative dose of GLP-1 agonist following their bariatric surgery. This includes semaglutide, tirzepitide, among others. The dosage will be variable, but will be the same dose the patient is on prior to the bariatric surgery. Dur...Mostra di più
GLP-1 receptor agonist
Randomized to continue or discontinue GLP-1 receptor agonists after bariatric surgery
Nessun interventoNon-GLP-1 Agonist Group
This cohort will consist of patients undergoing bariatric surgery who are currently receiving a GLP-1 Agonist for weight loss and/or diabetes management that will be required to stop taking their preoperative dose of GLP-1 agonist following their bariatric surgery. Dosage preoperative will be variable based on what the patient is currently taking, as well as the medication being taken.
N.D.
Esito primario
Misure di esitoDescrizione della misuraArco temporale
Effect of GLP1-RA on weight loss
To investigate the effects of GLP1-RAs on weight loss reflected as change in BMI (kg per meter sq) in patients undergoing metabolic surgery
6 months
Effect of GLP1-RA on circulating bile acids and metabolites
Determine the impact of GLP1-RA on circulating bile acids and other metabolites
6 months
Effector of GLP1-RA on gut microbiome diversity
To determine the impact of GLP1-RAs after bariatric surgery on changes in the gut microbiome
6 months
Effect of GLP1-RA on satiety and hunger
To assess the impact of GLP-1 agonists on satiety and hunger in patients who undergo metabolic surgery. Scale will be a validated scoring system, "Daily Eats Questionnaire," with scores ranging from 0-10, with a 0 indicating no hunger, and 10 indicating extreme hunger
6 months
Effect of GLP1-RA on Glycemic control
HGBA1C levels will be measured at 3 and 6 months after surgery to determine if HGBA1C drops more in patients maintained on GLP1-RA
6 months
Assistente alla partecipazione
Criteri di eleggibilità

Età idonea
Adulto, Adulto anziano
Età minima
18 Years
Sessi idonei
Tutti
  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.

  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
University of Missouri-Columbia logoUniversità del Missouri-Columbia94 studi clinici attivi da esplorare
American Society for Metabolic and Bariatric Surgery logoAmerican Society for Metabolic and Bariatric Surgery
Parte responsabile dello studio
Andrew Wheeler, Investigatore principale, Assistant Professor of Surgery, University of Missouri-Columbia
Contatti principali dello studio
Contatto: Jennifer Randolph, 573-882-4387, [email protected]
1 Centri dello studio in 1 paesi

Missouri

University of Missouri Hospital, Columbia, Missouri, 65201, United States
Andrew Wheeler, MD, Contatto, 573-882-5609, [email protected]
Milot Thaqi, MD, Contatto, 7086421788, [email protected]
In arruolamento