A Study to Establish a Biobank of Blood Samples to Study the Relationship Between Diabetes Mellitus and Other Pancreatic Conditions

Overview

Información sobre este estudio

The purpose of this study is to establish a biobank of blood samples to study the relationship between diabetes mellitus and other pancreatic conditions.

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:

  1. Willing to provide informed consent and sign an informed consent form.
  2. Must sign an authorization for the release of their protected health information.

Candidates must be ≥50 and ≤85 years of age

  1. Must have at least (1) Parameter of Diabetes Mellitus in the past (3) months:
  • Fasting Blood Glucose (FBG) ≥126 mg/dl
  • Hemoglobin A1c (HbA1c) ≥ 6.5%
  • Random Blood Glucose (RBG) ≥200 mg/dl
  • 2h Post Glucose (PG) ≥200mg (11.1 mmol/L) during OGTT (oral glucose tolerance test)

*Only the aforementioned glycemic parameters measured in outpatient setting are to be included.*

  1. Must have had glycemic parameters measured in the 3-18 months prior to screening without meeting criteria for DM or be on anti-DM medications
  1. Patient must be willing to provide blood samples (fasted) at baseline. 
  2. For subsequent serial bio-sampling, patient must meet criteria for NOD (New onset diabetes) (see Table 1 in Section 3.0) and be willing to provide blood samples (fasted) at 6, 12, and 24 months post-enrollment

Subjects or authorized representative must be willing to complete a  detailed questionnaire

In physician’s judgement, patient’s co-morbidities do not limit patient’s participation in study interventions (blood draw and questionnaire)

Exclusion Criteria:

  1. Patient met criteria for DM >90 days prior to enrollment, carried a physician diagnosis of DM or used anti-DM medications in the 3-18 months prior to enrollment
  2. Has had no glycemic parameter measured within 3-18 months prior to enrollment
  1. Patients must not be on active treatment for cancer, carry a current diagnosis of any cancer, and/or or be investigated for suspicion of recurrence of past cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix)
  2. Any past history of pancreatic cancer
  1. Current chronic or acute oral steroids
  2. Recent (within 1 week) intra-articular steroid injection

Allowed: Nasal, topical steroids, oral budesonide, ophthalmic

Blood sugar measured in stressful situations such as urgent care, emergency room, or as inpatient

Patients must not have any significant medical illnesses that in the investigator’s opinion cannot be adequately controlled with appropriate therapy or would compromise the patient’s ability to tolerate study interventions.

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

La Crosse, Wis.

Investigador principal de Mayo Clinic

Michael Van Norstrand, M.D., Ph.D.

Cerrado para la inscripción

Rochester, Minn.

Investigador principal de Mayo Clinic

Gloria Petersen, Ph.D.

Cerrado para la inscripción

Eau Claire, Wis.

Investigador principal de Mayo Clinic

Jaime Zighelboim, M.D.

Cerrado para la inscripción

More information

Publicaciones

Publications are currently not available
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CLS-20396298

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