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Hydrocortisone Vs Prednisolone in AI (HYPER-AID) (HYPER-AID)

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ClinicalTrials.gov Identifier: NCT03608943
Recruitment Status : Recruiting
First Posted : August 1, 2018
Last Update Posted : August 15, 2019
Sponsor:
Information provided by (Responsible Party):
Imperial College London

Brief Summary:
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.

Condition or disease Intervention/treatment
Adrenal Insufficiency Other: There is no specific intervention other than an individual changing their treatment as part of their usual care

Detailed Description:

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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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Crossover
Time Perspective: Retrospective
Official Title: Hydrocortisone Versus Prednisolone for Treatment of Adrenal Insufficiency Disease (HYPER-AID Study)
Actual Study Start Date : May 24, 2018
Estimated Primary Completion Date : March 20, 2023
Estimated Study Completion Date : March 20, 2023


Group/Cohort Intervention/treatment
Adrenal insufficiency

Individuals who are in the process of changing their treatment from:

  1. hydrocortisone to prednisolone or;
  2. prednisolone to hydrocortisone
Other: There is no specific intervention other than an individual changing their treatment as part of their usual care
There is no specific intervention other than an individual changing their treatment as part of their usual care




Primary Outcome Measures :
  1. P1NP [ Time Frame: Minimum 4 months of stable treatment ]
    measurement of bone turnover markers: P1NP,

  2. NTX [ Time Frame: Minimum 4 months of stable treatment ]
    measurement of bone turnover markers: NTX


Secondary Outcome Measures :
  1. Heart rate [ Time Frame: Minimum 4 months of stable treatment ]
    recording observations- heart rate

  2. Blood pressure [ Time Frame: Minimum 4 months of stable treatment ]
    recording observations- blood pressure

  3. Waist-hip circumference [ Time Frame: Minimum 4 months of stable treatment ]
    recording observations- waist-hip circumference ratios

  4. Lipid profile (Total cholesterol, HDL, LDL and triglycerides) [ Time Frame: Minimum 4 months of stable treatment ]
    measuring biochemical indicators of cardiovascular risk: total cholesterol, HDL, LDL and triglycerides

  5. High sensitivity CRP [ Time Frame: Minimum 4 months of stable treatment ]
    measuring biochemical indicators of cardiovascular risk: high sensitivity CRP

  6. Glucose [ Time Frame: Minimum 4 months of stable treatment ]
    assessed by measuring glucose

  7. HbA1c [ Time Frame: Minimum 4 months of stable treatment ]
    assessed by measuring HBA1c

  8. Frequency and severity of steroid replacement related symptoms [ Time Frame: Minimum 4 months of stable treatment ]
    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.)

  9. Efficacy of replacement and wellbeing [ Time Frame: Minimum 4 months of stable treatment ]
    assessed using subjective health questionnaire



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Individuals with either primary or secondary adrenal insufficiency who are currently receiving glucocorticoid replacement therapy with hydrocortisone or prednisolone.
Criteria

Inclusion Criteria:

  • Aged 18 - 85 years
  • Male or female
  • Diagnosed with adrenal insufficiency (AI) for over 6 months according to standard diagnostic criteria
  • Established on stable hydrocortisone or prednisolone replacement, dose not altered for at least 4 months
  • Individuals taking other hormone replacements are accepted providing that their replacement doses have not altered for at least 3 months;
  • Individuals who are able and willing to give written informed consent to participate in the study

Exclusion Criteria:

  • Individuals who are unable to give informed consent
  • Pregnancy (determined by patients self-reporting pregnancy status)
  • Patients using the combined oral contraceptive pill

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03608943


Contacts
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Contact: Sirazum Choudhury, MBBS MRCP 07555717544 steroids@imperial.ac.uk

Locations
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United Kingdom
Imperial College Healthcare NHS Trust Recruiting
London, United Kingdom, W12 8RF
Contact: Sirazum Choudhury, MBBS BSc    07555717544    steroids@imperial.ac.uk   
Sponsors and Collaborators
Imperial College London
Investigators
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Principal Investigator: Karim Meeran, MBBS BSc MD Imperial College London
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Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT03608943    
Other Study ID Numbers: 18HH4457
234243 ( Other Identifier: IRAS )
First Posted: August 1, 2018    Key Record Dates
Last Update Posted: August 15, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There are currently no plans to share individual data with other researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Imperial College London:
glucocorticoids
prednisolone
hydrocortisone
Additional relevant MeSH terms:
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Adrenal Insufficiency
Adrenal Gland Diseases
Endocrine System Diseases