Objective Markers and New Indicators in AI Disease (OMNI-AID Study)

NCT ID: NCT03615859

Last Updated: 2019-08-15

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-06-01
• Study Completion Date: 2021-04-02

Brief Summary

This pilot study is designed to compare healthy volunteers with three groups of patients with adrenal insufficiency and a final group of patients receiving high dose steroids for anti-inflammatory purposes. The study will collect data on all 5 groups with the intention of identifying any novel markers or immunological indicators which may be used clinically to gauge the adequacy of steroid replacement treatment in patients with adrenal insufficiency.

Detailed Description

Glucocorticoid replacement in adrenal insufficiency poses a significant challenge. If given too much, patients risk long term complications including diabetes, osteoporosis and cardiovascular disease. If, however they are given too little, patients can feel tired, unwell and may collapse as there is insufficient steroid hormone to cope with stress.

Currently there is no single objective marker or outcome that can be measured to ascertain whether a patient is receiving optimum glucocorticoid replacement therapy. This study will investigate a selection of markers to examine whether they can be used to as indicators to gauge the adequacy of therapy. Finding an appropriate marker could unlock better care and outcomes for our patients with adrenal insufficiency .

Conditions

Adrenal Insufficiency

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Healthy volunteers

Healthy volunteers whose data represents a negative control

No interventions assigned to this group

Prednisolone replacement group

Participants with adrenal insufficiency who are treated with replacement doses of prednisolone

No interventions assigned to this group

Hydrocortisone replacement group

Participants with adrenal insufficiency who are treated with replacement doses of hydrocortisone

No interventions assigned to this group

New adrenal insufficiency group

Participants who have recently been given a new diagnosis of adrenal insufficiency

No interventions assigned to this group

High dose steroids groups

Participants who are treated with high dose steroids for management of any medical condition to serve as a positive control

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Aged 18 - 85 years
• Male or female
• Participants who are otherwise healthy enough to participate, as determined by pre-study medical history and physical examination

Patient groups only:

• Diagnosed with AI for over 6 months according to standard diagnostic criteria or with a medical condition requiring acute high dose steroid therapy for anti-inflammatory purposes
• If diagnosed with AI, established on stable HC replacement or prednisolone replacement, dose not altered for at least 3 months
• Established on a stable dose of Fludrocortisone, if taking, dose not altered for at least 3 months
• Participants taking other hormone replacements (e.g. levothyroxine, testosterone or growth hormone in secondary adrenal insufficiency) are accepted providing that their replacement doses have not altered for at least 3 months
• Participants who are able and willing to give written informed consent to participate in the study.

Exclusion Criteria

• Participants with a diagnosis of Type 1 or Type 2 diabetes mellitus.
• Unable to give informed consent.
• Excessive caffeine intake above 500 mg per day.
• Taking supplements or herbal medications that the participant is unwilling or unable to stop prior to and during the study period e.g. St John's Wort (may decrease prednisolone levels), Cat's claw, Echinacea (immunomodulatory properties).
• Currently taking medications that alter CYP3A4 metabolism of glucocorticoids that the participant is unwilling or unable to stop prior to and during the study period e.g. phenytoin, phenobarbital, rifampicin, rifabutin, carbamazepine, primidone, aminogluethimide, itraconazole, ketoconazole, ciclosporin or ritonavir.
• Pregnancy, taking the oral contraceptive pill, or oral oestrogen replacement therapy due to the effects on cortisol binding globulin levels and determination of prednisolone levels. Transdermal oestrogen replacement is permitted. Females of child-bearing age will be asked to provide a urine sample for a pregnancy test at each visit.
• Diagnosis of growth hormone deficiency, untreated
• History of any medical, psychological or other condition, or use of any medications, including over-the-counter products, which, in the opinion of the investigators, would either interfere with the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute for Health Research, United Kingdom

OTHER_GOV

Sponsor Role: collaborator

Imperial College London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Karim Meeran, MBBS BSc MD

Role: PRINCIPAL_INVESTIGATOR

Imperial College London

Locations

Imperial College Healthcare NHS Trust

London, , United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Sirazum Choudhury, MBBS MRCP

Role: CONTACT

steroids@imperial.ac.uk

07555717544

Facility Contacts

Sirazum Choudhury, MBBS BSc

Role: primary

steroids@imperial.ac.uk

07555717544

Other Identifiers

216757

Identifier Type: OTHER

Identifier Source: secondary_id

18/LO/0069

Identifier Type: OTHER

Identifier Source: secondary_id

18HH4425

Identifier Type: -

Identifier Source: org_study_id