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Acute and chronic effects of glucocorticoids on carbohydrate metabolism in subjects with inflammatory rheumatologic disease.

Acute and chronic effects of glucocorticoids on carbohydrate metabolism in subjects with inflammatory rheumatologic disease.

Status
Suspended
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12610000409077
Enrollment
24
Registered
2010-05-21
Start date
2010-05-24
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The study aims to assess: * How low dose steroids affect insulin secretion and sensitivity * Whether low dose steroids increase the risk of heart disease We hope that this information will increase understanding of the risk of diabetes conferred by low dose steroids and how best to treat it. We will be studying participants with inflammatory joint disease. One group of participants will usually take prednisolone (a steroid tablet) for their joint disease. They will be studied once. The other group of participants will not usually be treated with prednisolone for their joint disease. This group of participants will be studied, and then they will be asked to take low dose prednisolone for 7-10 days before being studied again. On the first study day we will assess how sensitive the body is to insulin with an insulin clamp study. On the second day we will assess the risk of heart disease, how much insulin the body is making and body composition.

Interventions

Prednisolone 4-10mg/day orally for 7-10 days. We will be comparing participants with inflammatory rheumatologic disease who are on prednisolone as usual treatment with those who are not on prednisolone as usual treatment. Participants who are not on prednisolone as usual treatment will undergo a series of investigations and then take a short course of prednisolone. The prednisolone dose will be the mean dose of those who are usually on prednisolone (this group will be studied first). The course

Prednisolone 4-10mg/day orally for 7-10 days. We will be comparing participants with inflammatory rheumatologic disease who are on prednisolone as usual treatment with those who are not on prednisolone as usual treatment. Participants who are not on prednisolone as usual treatment will undergo a series of investigations and then take a short course of prednisolone. The prednisolone dose will be the mean dose of those who are usually on prednisolone (this group will be studied first). The course of prednisolone will be between 7-10 days, with this period being determined by the timing of repeat investigations. Participants who are on prednisolone as usual treatment will be tested once. Participants who are not on prednisolone as usual treatment will be followed up after 7-10 days for repeat investigations.

Sponsors

Dr Morton Burt
Lead SponsorIndividual

Study design

Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
40 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Inflammatory rheumatologic disease Group 1 - not currently on glucocorticoid therapy and have not been on glucocorticoid therapy for at least the last 6 months Group 2 - currently on glucocorticoid therapy (4-10mg/day), and have been on this therapy for at least 6 months

Exclusion criteria

Diagnosis of diabetes mellitus; Inability to provide informed consent; Medications which significantly affect carbohydrate metabolism; New York Heart Association (NYHA) class IV cardiac failure; Severe renal or hepatic disease; Inability to lie flat for 6 hours

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026