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| ID | Type | Description | Link |
|---|---|---|---|
| 234243 | Other Identifier | IRAS |
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This study is designed to collect data on individuals with adrenal insufficiency who are changing treatments from hydrocortisone to prednisolone, or vice versa. It will compare anthropometric, biochemical and subjective health outcomes between both treatments.
In the UK, oral immediate release hydrocortisone divided in three doses daily has been the traditional treatment. The most common regimen in clinical practice uses doses of 10 mg on waking, 5 mg at lunch time and 5 mg in the afternoon. Once daily prednisolone is another regimen in clinical use and now prescribed at less than 5mg daily. It has a longer duration of action and a smoother pharmacokinetic profile compared to hydrocortisone. Moreover, prednisolone is much more cost-effective than hydrocortisone with 5mg tablets. Prednisolone is less commonly used due to perceived concerns regarding loss of bone mineral density leading to osteoporosis, increased insulin resistance leading to steroid induced diabetes, and rises in blood pressure and weight leading to increased cardiovascular risk. This belief is perhaps driven by the fact that most clinicians encounter prednisolone in the context of the treatment of asthma, rheumatoid arthritis etc. where far higher doses are employed. Where effects on bone health have been noted, they have been in association with higher doses of prednisolone (7.5mg) than those employed today (2-5mg).
Although conventionally prednisolone 5 mg is assumed to be bioequivalent to HC 20 mg (ratio 1:4), newer studies suggest that the ratio may be nearer 1:6-8 i.e. lower doses can be used.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adrenal insufficiency | Individuals who are in the process of changing their treatment from:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| There is no specific intervention other than an individual changing their treatment as part of their usual care | Other | There is no specific intervention other than an individual changing their treatment as part of their usual care |
| Measure | Description | Time Frame |
|---|---|---|
| P1NP | measurement of bone turnover markers: P1NP, | Minimum 4 months of stable treatment |
| NTX | measurement of bone turnover markers: NTX | Minimum 4 months of stable treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Heart rate | recording observations- heart rate | Minimum 4 months of stable treatment |
| Blood pressure | recording observations- blood pressure |
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Inclusion Criteria:
Exclusion Criteria:
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Individuals with either primary or secondary adrenal insufficiency who are currently receiving glucocorticoid replacement therapy with hydrocortisone or prednisolone.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sirazum Choudhury, MBBS MRCP | Contact | 07555717544 | steroids@imperial.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Karim Meeran, MBBS BSc MD | Imperial College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imperial College Healthcare NHS Trust | Recruiting | London | W12 8RF | United Kingdom |
There are currently no plans to share individual data with other researchers
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| ID | Term |
|---|---|
| D000309 | Adrenal Insufficiency |
| ID | Term |
|---|---|
| D000307 | Adrenal Gland Diseases |
| D004700 | Endocrine System Diseases |
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| Minimum 4 months of stable treatment |
| Waist-hip circumference | recording observations- waist-hip circumference ratios | Minimum 4 months of stable treatment |
| Lipid profile (Total cholesterol, HDL, LDL and triglycerides) | measuring biochemical indicators of cardiovascular risk: total cholesterol, HDL, LDL and triglycerides | Minimum 4 months of stable treatment |
| High sensitivity CRP | measuring biochemical indicators of cardiovascular risk: high sensitivity CRP | Minimum 4 months of stable treatment |
| Glucose | assessed by measuring glucose | Minimum 4 months of stable treatment |
| HbA1c | assessed by measuring HBA1c | Minimum 4 months of stable treatment |
| Frequency and severity of steroid replacement related symptoms | assessed by reporting of symptoms of steroid deficiency, their frequency and severity stratified by the patient's current replacement regimen. Symptoms include nausea, lethargy, muscle pain, headaches etc.) | Minimum 4 months of stable treatment |
| Efficacy of replacement and wellbeing | assessed using subjective health questionnaire | Minimum 4 months of stable treatment |