None listed
Conditions
Brief summary
Steroids are commonly used medications used to treat for inflammatory conditions. They raise glucose levels. In this study, we will test in people with type 2 diabetes whether changing the timing of doses of oral steroids to twice a day administration, compared to the usual morning dosing, produces a more even pattern of glucose levels and less glucose fluctuation. The study will use continuous glucose monitoring to assess glucose patterns before, during and after three days of steroids.
Interventions
Oral prednisolone twice a day given as 10 mg doses at 08:00 and 18:00 (time is 24 hour clock time), for 3 days. Adherence will be monitored by drug tablet return and participant diary. There is a wash-out period between treatments of 3 weeks.
Sponsors
Baker IDI Heart and Diabetes Institute
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Informed consent obtained before any trial-related activities 2. Male or female 3. Age greater than or equal to 18 years 4. Type 2 diabetes, diagnosis established from medical history 5. Duration of diabetes greater than or equal to 6 months 6. Stable daily dose of anti-diabetic medications for at least 60 days preceding the screening visit 7. HbA1c 6.5% to 9.9% (48 to 85 mmol/mol, both inclusive) at screening visit 8. Current treatment for diabetes: diet and exercise, metformin, a sulphonylurea, pioglitazone, a dipeptidyl peptidase 4 inhibitor, acarbose 9. Body mass index greater than or equal to 18 kg/m2 and less than or equal to 40 kg/m2 10. Able and willing to perform self-monitoring of glucose levels according to the protocol, to keep a log sheet for glucose levels and food diary, and use the continuous glucose monitoring system. 11. Participant, if female, agrees to avoid pregnancy while participating in the study.
Exclusion criteria
1. Type 1 diabetes, gestational diabetes or secondary diabetes (e.g. Cushing’s syndrome) 2. On treatment with insulin within 60 days of the screening visit 3. On treatment with GLP-1 receptor agonists within 60 days of the screening visit 4. Pregnant, lactating or intends to become pregnant during the course of the study 5. Body mass index < 18 kg/m2 or > 40 kg/m2 6. Clinically significant, active (during the past 12 months) disease of the gastrointestinal, pulmonary, neurological, genitourinary, renal, hepatic or haematological system (except for conditions associated with type 2 diabetes), that in the opinion of the Investigator, may confound the results of the trial 7. Severe uncontrolled treated or untreated hypertension (systolic blood pressure >160 mm Hg or diastolic blood pressure >95 mm Hg) 8. Current or anticipated requirement for medications (e.g. oral or injected steroids required for arthritis or asthma or chronic pulmonary disease) or operations that will adversely affect glucose metabolism during the trial 9. Inability to perform self monitoring of glucose with a blood glucose meter. 10. Participation in another clinical trial. The participant must have completed any previous study at least 30 days before the screening visit. 11. Mental incapacity, unwillingness, language barrier or other factor that in the investigator’s opinion precludes adequate understanding of the trial procedure or cooperation with trial site personnel. 12. Abuse of alcohol or narcotics
Outcome results
None listed