Risk Prediction for Immune Checkpoint Inhibitor Associated Diabetes Mellitus

Overview

About this study

The purpose of this study is to identify risk factors for ICI associated diabetes mellitus and to assess the severity and natural course of this immune related adverse effect.

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:

For Cases

  • Provide voluntary and written informed consent to be included in the study (for those who are not fluent in English, we will consult an interpreter who can go over the consent with patient).
  • Must be willing to undergo blood collections as outlined in the protocol.
  • Meeting criteria for new onset DM or worsening of existing type 2 DM after initiation of ICI:
    • New onset of diabetes mellitus any time after initiating ICI therapy based on criteria: HbA1c >6.4 % or FPG ≥126mg/dl on two occasions or OGTT >199 on two occasions or symptoms with RPG ≥200 mg/dl or initiation of any therapy for diabetes mellitus or diabetic ketoacidosis (DKA).
  • Worsening of existing type 2 diabetes mellitus any time after initiating ICI therapy based on criteria: unexplained HbA1c increase by 10%, sudden RPG ≥200 mg/dl, episode of DKA, clinical need for 2nd agent or insulin for diabetes mellitus, new onset ketonuria or new onset ketonemia (elevated beta hydroxybutyrate in blood) with uncontrolled diabetes.
  • Meeting criteria for hypophysitis after initiation of ICI:
    • MRI evidence of hypophysitis demonstrated by enlarged and enhancing pituitary gland and stalk or small pituitary which can be a consequence of initial pituitary swelling;
    • Biochemical evidence of hypopituitarism even in the absence of MRI findings.

For Controls

  • Provide voluntary and written informed consent to be included in the study (for those who are not fluent in English, we will consult an interpreter who can go over the consent with patient).
  • Must be willing to undergo blood collections as outlined in the protocol.

Exclusion Criteria:

For Cases

  • Prisoners
  • Not willing to voluntarily consent or if withdraw consent at any time during the course or of the study.
  • Preexisting diagnosis of autoimmune (type 1) diabetes mellitus.
  • Pregnant.

For Controls

  • Prisoners
  • Not willing to voluntarily consent or if withdraw consent at any time during the course or of the study.
  • Pregnant.

 

 

 

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

Yogish Kudva, M.B.B.S.

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:

Anupam Kotwal M.B.B.S.

(507) 266-0500

Kotwal.Anupam@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-20426681

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