RecruitingACTRN12621001106820

Optimum Diagnostic Testing for Glucocorticoid Induced Hyperglycaemia

Sponsor

Associate Professor Morton Burt

Enrollment

100 participants

Start Date

Sep 10, 2021

Study Type

Observational

Conditions

Diabetes induced by Glucocorticoids

Summary

We hypothesise that a random afternoon glucose has superior sensitivity to a fasting blood glucose to diagnose diabetes in patients taking long-term prednisolone. Hyperglycaemia is a known adverse effect of Prednisolone and previous research has demonstrated that the pattern of hyperglycaemia seen in patients taking prednisolone, typically occurs in the afternoon with less of an effect on morning fasting blood glucose levels. In the clinical setting, the diagnosis of diabetes can made via different testing modalities. Taking into account the pattern of hyperglycaemia caused by prednisolone, the sensitivity of each of the diagnostic modalities may vary. As a result, we will compare a random afternoon blood glucose to a morning fasting glucose. These two testing modalities will be compared to the current gold standard test which is an oral glucose tolerance test.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Prednisolone is a commonly prescribed steroid medication used for a wide range of conditions, including arthritis, asthma, and autoimmune diseases. One well-known side effect is that it raises blood sugar levels, sometimes enough to cause steroid-induced diabetes. Detecting this is important so it can be properly managed. The challenge is that prednisolone tends to raise blood sugar most in the afternoon, not in the morning — which is when the standard fasting blood glucose test is done. This study is comparing three blood sugar tests in patients taking long-term prednisolone: a morning fasting test, a random afternoon test, and the gold-standard oral glucose tolerance test, to find out which detects steroid-induced diabetes most reliably. You may be eligible if you are 18 or older and have been taking more than 4mg of prednisolone per day for at least three months. The study is not open to people who already have a diabetes diagnosis, are pregnant, or have significant kidney, liver, or pancreatic problems.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

This trial will evaluate the optimum diagnostic testing for prednisolone induced hyperglycaemia. Participants who are taking prednisolone for greater than 3 months at a dose of greater than 4 mg, will be asked to participate in this study. Participants who have consented to take part in the study, who are taking greater than 4 mg of prednisolone will each undergo an oral glucose tolerance test (OGTT) and a random afternoon blood glucose on a separate day and at least 48 hours after their OGTT Exposure 1, Oral glucose tolerance test (OGTT) - The participant will be fasting from 10 pm prior to the day of their OGTT. They will then present to our Endocrine clinic the following morning. (Marion GP plus, Adelaide South Australia) On arrival in the morning, they will be met by one of the study investigators and have their BMI calculated, waist and hip circumference measured, and an intravenous cannula will be inserted by one the study investigators. Each investigator that has participant contact will be either a medical doctor with greater than 5 years experience, or a study nurse with more than 5 years experience. A blood sample will be taken from this cannula on insertion. The following markers will be tested for as a baseline 1) Glycosylated Haemoglobin 2) Fasting Glucose 3) Liver Function Tests 4) Lipid Profile 5) C-reactive protein 6) Renal function 7) Fasting insulin concentration Participants will then be given an oral glucose load of 75 grams which they will consume orally. They will remain on site at the clinic for 2 hours, after which a second blood sample will be taken to monitor their blood glucose levels. Participants will then have their Intravenous cannula removed and this will complete the first intervention. The total anticipated duration of the OGTT session will take up to 2.5 hours. Exposure 2, Random afternoon glucose – Each participant on a separate day and at least 48 hours after their OGGT, will undergo a blood test at a pathology collection (SA Pathology) centre to measure a random afternoon blood glucose. This test will take place between 2 pm and 6 pm. The total duration of this session will be no more than 15 minutes Each participants fasting glucose, oral glucose tolerance test and random afternoon blood glucose results will be reviewed to determine the difference in diagnostic accuracy between these modalities

Locations(3)

Flinders Medical Centre - Bedford Park

SA, Australia

Noarlunga Health Service - Noarlunga Centre

SA, Australia

Repatriation General Hospital - Daw Park

SA, Australia

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ACTRN12621001106820