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

NCT03615859 | Unknown

• 3 other identifiers: 18HH442521675718/LO/0069
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Adrenal Insufficiency

Keywords

Glucocorticoids; Hydrocortisone; Prednisolone

Outcome Measures

Primary Outcomes (1)

• Osteocalcin

  Assesses bone health of each group by comparing total osteocalcin and undercarboxylated osterocalcin

  Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.

Secondary Outcomes (11)

• P1NP

  Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.

• NTX

  Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.

• Heart Rate

  Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.

• Blood pressure

  Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.

• Waist-Hip circumference

  Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.

Study Arms (5)

Healthy volunteers

Healthy volunteers whose data represents a negative control

Prednisolone replacement group

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

Hydrocortisone replacement group

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

New adrenal insufficiency group

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

High dose steroids groups

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

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• 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. Healthy volunteers will serve as positive controls. Patients on high (anti-inflammatory) doses of steroids for any other medical condition will serve as positive controls.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Imperial College London: lead
• National Institute for Health Research, United Kingdom: collaborator

Study Sites (1)

Imperial College Healthcare NHS Trust

London, W12 8RF, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum, plasma, urine and peripheral blood mononuclear cells will be stored as part of this study

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: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2018
• First Posted: August 6, 2018
• Study Start: June 1, 2018
• Primary Completion: April 2, 2021
• Study Completion: April 2, 2021
• Last Updated: August 15, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)