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

Reclutando
Los detalles del ensayo clínico están disponibles principalmente en inglés. ¡Sin embargo, IA Trial Radar puede ayudar! Simplemente haga clic en 'Explicar el estudio' para ver y discutir la información del estudio en el idioma que haya seleccionado.
El ensayo clínico NCT06132477 está diseñado para estudiar el tratamiento de Obesidad mórbida, Síndrome metabólico, Diabetes mellitus, Hipertensión, Apnea obstructiva del sueño en adultos. Es un estudio intervencionista de Fase IV. Su estado actual es: reclutando. El estudio se inició el 1 de febrero de 2024, con el objetivo de reclutar a 150 participantes. Dirigido por la Universidad de Misuri, se espera que finalice el 1 de julio de 2030. Los datos se actualizaron por última vez en ClinicalTrials.gov el 22 de enero de 2026.
Resumen
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...Mostrar más
Descripción detallada
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...Mostrar más
Título oficial

Biometabolic Impact of Continuation of GLP-1 Agonists Following Bariatric

Condiciones médicas
Obesidad mórbidaSíndrome metabólicoDiabetes mellitusHipertensiónApnea obstructiva del sueño en adultos
Publicaciones
Artículos científicos y trabajos de investigación publicados sobre este estudio clínico:
Otros ID del estudio
  • 2098885
Número del NCT
NCT06132477
Inicio del estudio (real)
2024-02-01
Última actualización
2026-01-22
Fecha de finalización (estimada)
2030-07
Inscripción (prevista)
150
Tipo de estudio
Intervencionista
FASE
Fase IV
Estado general
Reclutando
Palabras clave
glp-1 agonist
Morbid Obesity
Bariatric Surgery
Metabolic syndrome
Diabetes Mellitus
Hypertension
Obstructive Sleep Apnea
Objetivo principal
Tratamiento
Método de asignación
Aleatorizado
Modelo de intervención
Diseño cruzado
Enmascaramiento
Ninguno (Abierto)
Brazos / Intervenciones
Grupo de participantesIntervención/Tratamiento
Comparador activoGLP-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...Mostrar más
GLP-1 receptor agonist
Randomized to continue or discontinue GLP-1 receptor agonists after bariatric surgery
Sin intervenciónNon-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/A
Resultado primario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
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
Asistente de participación
Criterios de elegibilidad

Criterios de edad
Adulto, Adulto mayor
Edad mínima
18 Years
Criterios de sexo
Todos
  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 logoUniversidad de Misuri94 estudios activos para explorar
American Society for Metabolic and Bariatric Surgery logoAmerican Society for Metabolic and Bariatric Surgery
Parte responsable del estudio
Andrew Wheeler, Investigador principal, Assistant Professor of Surgery, University of Missouri-Columbia
Contactos centrales del estudio
Contacto: Jennifer Randolph, 573-882-4387, [email protected]
1 Centros del estudio en 1 países

Missouri

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