A Study to Establish a New Onset Hyperglycemia and Diabetes Cohort

Overview

About this study

The purpose of this study is to establish a cohort of new onset diabetes patients.

 

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:

  • Patient must be ≥ 50 and ≤ 85 years of age at the time of diagnosis (index PDM date).
  • Patient is able and willing to provide informed consent and sign an informed consent form ≤ 90 days after the index PDM date.
  • Patient must sign an authorization for the release of their protected health information ≤ 90 days after the index PDM date.

New Onset Hyperglycemia and Diabetes (NOD) related:

  • Patient must have hyperglycemia and/or diabetes defined as one of the following in ≤ 90 days prior to the date of study consent.
  • *All glycemic parameters, except for HbA1c, must be measured in an outpatient setting:
    • (1) Glycated hemoglobin (HbA1c) ≥ 6.5% present
      • HbA1c measured in urgent care, emergency department, or inpatient is acceptable; 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.*
      • *Patient is still eligible if there are non-elevated glycemic parameters following anti-diabetes medication.
  • Patient must have > 1 glycemic parameter measured in the past 548 days (approximately 18 months) prior to the index PDM date without meeting inclusion criteria A, B, or C.

Biospecimen and Questionnaire:

  • Patient must be willing to provide blood samples (fasting) at baseline, and at 6, 12, and 24 months after baseline.
  • Patient or authorized representative must be willing to complete a detailed questionnaire.

Exclusion Criteria:

Personal history of Hyperglycemia, Diabetes, and Cancer:

  • Patient must not have any known past history of hyperglycemia and/or diabetes.
    • *Transient diabetes (e.g., gestational and steroid-induced) is not an exclusion.
  • Patient must not be on active treatment for cancer, carry a current diagnosis of any cancer, and/or 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.
  • Patient must not have any past history of pancreatic cancer.

Diabetes and Steroid Medications:

  • Patient must not be on any diabetes medications prior to the index PDM date.
  • Patient must not be on chronic or acute use of steroid medications ≤ 90 days prior to the index PDM date.
    • *Allowed: Nasal, topical steroids, oral budesonide, ophthalmic
  • Patient must not have had an intra-articular steroid injection ≤ 7 days prior to the index PDM date.

Chronic Severe Illness:

  • In the physician’s and/or investigator’s judgement, patient does not have any co-morbidities that limit the patient’s participation in the study.

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

Santhi Swaroop Vege, M.D.

Closed for enrollment

Contact information:

Corinna Sabaque M.P.H.

(507) 422-5993

Sabaque.Corinna@mayo.edu

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

La Crosse, Wis.

Mayo Clinic principal investigator

Harika Balagoni, M.B.B.S.

Closed for enrollment

Contact information:

NOD Research Study Team

(833) 250-5364

Eau Claire, Wis.

Mayo Clinic principal investigator

Sushil Kumar Garg, M.B.B.S.

Closed for enrollment

Contact information:

NOD Research Study Team

(833) 250-5364

More information

Publications

Publications are currently not available