Evaluation of a Mixed Meal Test for Diagnosis and Characterization and Type 3c Diabetes Mellitus Secondary to Pancreatic Cancer and Chronic Pancreatitis (DETECT)

Overview

Información sobre este estudio

The purpose of this study is to develop a blood test to distinguish various causes of diabetes by evaluating patients who have developed diabetes within the last 3 years, but we will also enroll a small number of patients with long-term diabetes and normal blood sugars for comparison. 

Diabetes mellitus is a common condition which is defined by persistently high blood sugar levels.  This is a frequent problem that is most commonly due to type 2 diabetes.  However, it is now recognized that a small portion of the population with diabetes have an underlying problem with their pancreas, such as chronic pancreatitis or pancreatic cancer, as the cause of their diabetes.  Currently, there is no test to identify the small number of patients who have diabetes caused by a primary problem with their pancreas.

 

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:

  • All patients must sign an informed consent indicating that they are aware of the investigational nature of this study. Patients must have signed an authorization for the release of their protected health information.
  • Patients must be ages ≥ 40 and < 85.
  • Patients must have a diagnosis of one of the following based on study definitions.
  • New Onset Diabetes (< 3 years) in subjects with Pancreatic Cancer (PDAC).
  • New Onset Diabetes (< 9 years) in subjects with Chronic Pancreatitis.
  • New Onset Diabetes (< 3 years) in subjects without Pancreatic disease (i.e., T2DM).
  • Long standing T2DM (≥ 3 years) without Pancreatic disease.
  • Long standing diabetes (≥ 3 years) in subjects with PDAC.
  • Long standing diabetes (≥ 9 years) subjects with chronic pancreatitis.
  • Non-diabetic subjects with PDAC.
  • Non-diabetic subjects with chronic pancreatitis.
  • Non-diabetic controls without Pancreatic disease.

Exclusion Criteria:

  • Subjects must not have any significant medical illnesses (including diabetes) that in the investigator’s opinion cannot be adequately controlled with appropriate therapy or would compromise the patient’s ability to tolerate study interventions.
  • Diabetes not stable enough to permit holding of diabetes medications.
  • Subjects taking higher doses of insulin (≥ 0.75 unit/kg/day).
  • Subjects in the non-pancreatic disease subgroup (i.e., T2DM) on longer acting agents, including thiazolidinediones and once-weekly GLP-1 agonists (Bydureon [exenatide], Ozempic [semaglutide], Trulicity [dulaglutide]). Conversely, the use of these medications is permitted for subjects in the CP and PDAC groups.
  • Patients currently receiving oral steroid medications.
  • Hospitalization for acute pancreatitis within 2 months before study visit (with the exception of subjects enrolled into the PDAC group as this may be a symptom of the disease).
  • The presence of a symptomatic cyst in subjects with CP. The presence of a cyst in subjects with pancreatic cancer is not an exclusion, including cancer arising from a mucinous cystic lesion.
  • Any subject with a pancreatic cancer histologic subtype other than adenocarcinoma (e.g., subjects with pancreatic neuroendocrine tumors are excluded).
  • Previous pancreatic surgery (including total pancreatectomy, pancreaticoduodenectomy, distal pancreatectomy, pancreaticojejunostomy, enucleation, or Frey procedure).
  • Previous treatment for pancreatic cancer, including chemotherapy or radiation.
  • Previous vagotomy or gastric surgery, including endoscopic gastric reduction procedures.
  • Previous diagnosis of gastroparesis.
  • Patients on treatment for any cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix).
  • Allergy or intolerance to ingredients in Boost drink.

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

Yogish Kudva, M.B.B.S.

Abierto para la inscripción

Contact information:

Heidi Gage

(507) 266-6482

PROCEED@mayo.edu

More information

Publicaciones

Publications are currently not available

Información adicional de contacto

Formulario de contacto para ensayos sobre cáncer

Teléfono: 855-776-0015 (toll-free)

Preguntas de estudios clínicos para pacientes internacionales