A Study to Establish a Biobank of Blood Samples to Study the Relationship Between Diabetes Mellitus and Other Pancreatic Conditions
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- La Crosse, Wisconsin: 17-009881
- Rochester, Minnesota: 17-009881
- Eau Claire, Wisconsin: 17-009881
Sponsor Protocol Number: 17-009881
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:
- Willing to provide informed consent and sign an informed consent form.
- Must sign an authorization for the release of their protected health information.
Candidates must be ≥50 and ≤85 years of age
- 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.*
- 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
- Patient must be willing to provide blood samples (fasted) at baseline.
- 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:
- 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
- Has had no glycemic parameter measured within 3-18 months prior to enrollment
- 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)
- Any past history of pancreatic cancer
- Current chronic or acute oral steroids
- 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 |
|
La Crosse, Wis.
Mayo Clinic principal investigator Michael Van Norstrand, M.D., Ph.D. |
Closed for enrollment |
|
Rochester, Minn.
Mayo Clinic principal investigator Gloria Petersen, Ph.D. |
Closed for enrollment |
|
Eau Claire, Wis.
Mayo Clinic principal investigator Jaime Zighelboim, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available