Use of parenteral corticosteroids and risk of type 2 diabetes mellitus.

Study type
Protocol
Date of Approval
Study reference ID
16_091
Lay Summary

Corticosteroids (CS) are widely used to treat a variety of diseases. It is well established that oral CS have a hyperglycaemic effect (increase in blood sugar values). Furthermore, the risk of developing corticosteroid-induced diabetes mellitus has been described previously. However, unlike oral CS use, there is minimal or no data regarding the development of new onset type 2 diabetes mellitus (T2DM) among parenteral CS users. Therefore, in this study we will evaluate the association between the use of parenterally administered CS and the risk of new onset T2DM.

Technical Summary

The objective is to evaluate the risk of new onset type 2 diabetes mellitus among patients using parenteral corticosteroids (intraarticular/intrabursal/periarticular/intramuscular/intradermal). Within the CPRD, all patients (at least 18 years of age) who have their first ever prescription record for a non-insulin antidiabetic drug (NIAD) recorded will be selected as cases.. To each T2DM patient, one control patient (no T2DM) without a NIAD or insulin prescription during the entire study period will be selected using incidence density sampling, and will be matched by year of birth, sex, and GP practice. Use of parenteral CS will be determined by reviewing dispensing information before index date. Conditional logistic regression analysis will be used to estimate the risk of T2DM therapy associated with use of parenteral CS and the various confounding variables.

Health Outcomes to be Measured

Cases will be defined as patients with a new onset of T2DM. A patient with a record of a NIAD will be defined as case in this study.

Collaborators

Frank de Vries - Chief Investigator - Utrecht University
Frank de Vries - Corresponding Applicant - Utrecht University
A Keyany - Collaborator - Sint Maartenskliniek
Bart Van den Bemt - Collaborator - Sint Maartenskliniek
Johannes T.H. Nielen - Collaborator - Utrecht University