A Study to Evaluate the Effect of Improving Glycemic Control on Gastric Emptying in Type 1 and Type 2 Diabetes Mellitus

Overview

Información sobre este estudio

The purpose of this study is to evaluate the effects of improving glycemic control, and/or reducing glycemic variability on gastric emptying, intestinal barrier function, autonomic nerve functions, and epigenetic changes in subjects with type 1 diabetes mellitus (T1DM) and  type 2 diabetes mellitus (T2DM) who are switched to intensive insulin therapy as part of clinical practice.

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:

  • T1DM or T2DM of duration ≥ 5 years.
  • HbA1C > 7.5 %.
  • Able to provide written informed consent before participating in the study.
  • Able to communicate adequately with the investigator and to comply with the requirements for the entire study.

Exclusion Criteria:

  • Severe nausea or vomiting precluding study assessments.
  • Use of medications that alter GI motility; e.g., narcotics or medications with significant anticholinergic effects. Subjects using metoclopramide or erythromycin will be enrolled provided it is safe to hold these medications for 48 hours before study procedures.
  • Patients likely to be treated with medications that directly affect gastrointestinal motility; e.g., pramlintide or GLP-1.
  • Patients likely to undergo major procedures; e.g., pancreas transplantation, dialysis or kidney transplantation within the next 3 months.
  • No nonsteroidal anti-inflammatory drugs (NSAIDS) or aspirin should be taken in the week before this test; this is an agent of exclusion only if medically safe to do so.
  • Patients who are allergic to eggs, wheat or milk or unwilling to consume these products.
  • For female patients who will participate in the validation arm of the study, pregnancy or breast feeding.

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 Contacto

Rochester, Minn.

Investigador principal de Mayo Clinic

Adil Bharucha, M.B.B.S., M.D.

Abierto para la inscripción

Contact information:

Amber Galbreath

(507)538-3883

Galbreath.Amber@mayo.edu

More information

Publicaciones

Publications are currently not available
.
CLS-20308211

Mayo Clinic Footer