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

Overview

About this study

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

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Suresh Chari, M.D.

Closed for enrollment

Contact information:

Cynthia Beinhorn

Beinhorn.Cynthia@mayo.edu

La Crosse, Wis.

Mayo Clinic principal investigator

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

Closed for enrollment

Contact information:

Cynthia Beinhorn

(833)527-2442

Beinhorn.Cynthia@mayo.edu

Eau Claire, Wis.

Mayo Clinic principal investigator

Jaime Zighelboim, M.D.

Closed for enrollment

Contact information:

Cynthia Beinhorn

(833)527-2442

Beinhorn.Cynthia@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20396298

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