A Study of the Metabolome and Microbiome Following Bariatric Surgery, and the Effect on Metabolism in Patients with Type 2 Diabetes

Overview

Información sobre este estudio

The purpose of this study is to identify changes to the metabolome (range of chemicals produced in the body) and microbiome (intestine microbe environment) that are unique to Roux-en-Y gastric bypass surgery and assess the associated effect on the metabolism of patients with type 2 diabetes.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Inclusion Criteria

  • Individuals aged 20-65 years
  • Seen for weight management in the Nutrition Clinic at the Mayo Clinic
  • Recruited prior to undergoing Roux-en-Y Gastric Bypass surgery
  • Have a fasting glucose concentration of ≥ 126 mg/dl on two or more occasions
  • Or  have a history of type 2 diabetes or impaired fasting glucose treated with one or two oral agents other than thiazolidinediones
  • Control group with type 2 diabetes or impaired fasting glucose who are not interested in pursuing surgical intervention but are willing to undergo supervised caloric restriction 
    • The 2 groups will be matched for age, gender, BMI and the duration and severity (HbA1c and number of oral medications needed to achieve glycemic control) of diabetes

 

Exclusion Criteria

  • Subjects < 20 years of age will not be studied to minimize the possibility of type 1 diabetes
  • Subjects > 65 years of age will not be studied to minimize the potential confounding effects of age on glucose tolerance
  • Subjects on chronic antibiotic therapy will be excluded due to their influence on gut bacteria
    • Subjects will refrain from using antibiotics for 2 weeks prior to the screening visit until completion of the study, except for routine peri-operative use and as clinically indicated
  • Healthy status will indicate that the participant has no known active systemic illness and no active microvascular or macrovascular complications of their diabetes

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus

Rochester, Minn.

Investigador principal de Mayo Clinic

Meera Shah, M.B., Ch.B.

Cerrado para la inscripción

More information

Publicaciones

Publications are currently not available
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CLS-20164526

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