Hydrocortisone Vs Prednisolone in AI (HYPER-AID)

NCT03608943 | Unknown

• 2 other identifiers: 18HH4457234243
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Adrenal Insufficiency

Keywords

glucocorticoids; prednisolone; hydrocortisone

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (9)

• Heart rate

  Minimum 4 months of stable treatment

• Blood pressure

  Minimum 4 months of stable treatment

• Waist-hip circumference

  Minimum 4 months of stable treatment

• Lipid profile (Total cholesterol, HDL, LDL and triglycerides)

  Minimum 4 months of stable treatment

• High sensitivity CRP

  Minimum 4 months of stable treatment

Study Arms (1)

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

Interventions

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

Adrenal insufficiency

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Imperial College Healthcare NHS Trust

London, W12 8RF, United Kingdom

RECRUITING

MeSH Terms

Conditions

Adrenal Insufficiency

Condition Hierarchy (Ancestors)

Adrenal Gland Diseases; Endocrine System Diseases

Study Officials

• Karim Meeran, MBBS BSc MD

  Imperial College London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sirazum Choudhury, MBBS MRCP

CONTACT

07555717544; steroids@imperial.ac.uk

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2018
• First Posted: August 1, 2018
• Study Start: May 24, 2018
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: November 29, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)