A Prospective Study to Establish a New Onset Hyperglycemia and Diabetes (NOD) Cohort

Overview

About this study

The purpose of this study is to prospectively assemble a cohort of subjects >50 and ≤85 years of age with New-onset Diabetes (NOD):

  • Estimate the probability of pancreatic ductal adenocarcinoma (PDAC) in the NOD Cohort;
  • Establish a biobank of clinically annotated biospecimens including a reference set of biospecimens from pre-symptomatic PDAC and control new-onset type 2 diabetes mellitus (DM) subjects;
  • Facilitate validation of emerging tests for identifying NOD subjects at high risk for having PDAC using the reference set; and
  • Provide a platform for development of an interventional protocol for early detection of sporadic PDAC NOD subjects.

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:

  • Subject is able and willing to provide informed consent and sign an informed consent form.
  • Subject must sign an authorization for the release of their protected health.
  • Candidates must be ≥ 50 and ≤ 85 years of age at the time of enrollment.
  • Subject must have hyperglycemia and/or diabetes as one of the following within 90 days prior to enrollment:
    • *All glycemic parameters must be measured in an outpatient setting.
    • Hemoglobin A1c (HbA1c) ≥ 6.5% present; or
    • Any (2) PDMs present on consecutive or simultaneous testing:
      • 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); or
    • Any (1) PDM present followed by an anti-diabetes medication.
  • Subject must have > 1 had glycemic parameters measured in the 18 months prior to the elevated index lab without meeting inclusion criteria A, B, or C.
  • Subject must be willing to provide blood samples (fasting) at baseline, 6, 12, and 24 months post-enrollment.
  • Subject or authorized representative must be willing to complete a detailed questionnaire.

Exclusion Criteria:

  • Subject must not have any past history of hyperglycemia and/or diabetes as defined by inclusion criteria A, B, or C.
    • *Transient diabetes (e.g., gestational and steroid-induced) is not an exclusion.
  • Subject 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).
    • *Ongoing work up for suspicion of pancreatic cancer is not an exclusion.
  • Subject must not have any past history of pancreatic cancer.
  • Subject must not be on anti-diabetes medications prior to the elevated index lab.
  • Subject must not be onCurrent chronic or acute use oforal steroid medications within 90 days of the elevated index lab.
    • *Allowed: Nasal, topical steroids, oral budesonide, ophthalmic.
  • Subject must not have had a recent (within 1 week of the elevated index lab) intra-articular steroid injection.
  • In the physician’s and/or investigator’s judgement, subject does not have any co-morbidities that limit the subject’s participation in the study.
  • This study was designed to include women and minorities, but was not designed to measure differences among them.
  • Males and females will be recruited with no preference to gender.
  • No exclusion to this study will be based on race.
  • Minorities will actively be recruited to participate.

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

Gloria Petersen, Ph.D.

Closed-enrolling by invitation

What is this? (?)
"Close"
Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.

Contact information:

NOD Research Study Team

(833) 250-5364

Mankato, Minn.

Mayo Clinic principal investigator

Omar Mousa, M.B.B.S., M.D.

Closed for enrollment

Contact information:

NOD Research Study Team

(833) 250-5364

Eau Claire, Wis.

Mayo Clinic principal investigator

Jaime Zighelboim, M.D.

Closed for enrollment

Contact information:

NOD Research Study Team

(833) 250-5364

La Crosse, Wis.

Mayo Clinic principal investigator

Sebastian Strobel, M.D.

Closed for enrollment

Contact information:

NOD Research Study Team

(833) 250-5364

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-20491493

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