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Dosages of less than 5 mg prednisolone per day are not significant and no steroid cover is requiredby the Food and Drug Administration (1⇓⇓–3). However, given this pharmacokinetic profile, no one would have been able to detect the association between prednisolone use and HOMA-IR with the dose. The aim of the present study was to study the associations between prednisolone use and HOMA-IR.
METHODS Participants Participants were all healthy, white adults (18 years of age or older) living in the community of Boston, Massachusetts, USA. Participants were randomly assigned 0–5 mg prednisolone per day and were recruited from the Massachusetts Biomedical Research Institute (MBRI; http://biomedicine.mbri.org) using the Boston Marathon (MBM) site (http://nmdaily.mbri.org/) [21]. Randomization is based on an algorithm based on the probability of success for randomized clinical trials in the United States. Participants were contacted with the questionnaire at least 4 weeks prior to their first testing (and at baseline for all participants) to confirm their participation. Participants were then screened for physical activity in a structured telephone interview and their eligibility to participate was verified by a medical record review. They were excluded if they were smoking, taking any type of medication, had a history of cardiovascular disease (CVD), diabetes, or renal failure, did not have a baseline HOMA-IR of greater than 0.84 (5-µL/L), had a BMI of 35 kg/m2 or higher, or had a history of a prior episode of diabetes mellitus. This exclusion criteria is likely to be more general than the exclusion criteria suggested by the authors. We also excluded anyone who was receiving oral antidiabetic medications or insulin. Randomization was implemented by means of a computer-generated, pseudo-random number-generator with the following allocation sequence: 20 participants would randomly be assigned to receive 20 mg prednisolone for 3 weeks each on two separate occasions, 20 participants who would randomly be assigned to receive prednisolone for 4 weeks on two separate occasions, 20 participants randomly be assigned to receive 20 mg prednisolone for 3 weeks each on two separate occasions, 20 participants who would randomly be assigned to receive 10 mg prednisolone for 4 weeks on two separate occasions, and 20 participants who would randomly be assigned to receive 10 mg prednisolone for 4 weeks on two separate occasions. Randomization was stratified by sex. The primary aim of this study was
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