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

• Conditions: Adrenal Insufficiency

• Registration Number: NCT03615859
• Lead Sponsor: Imperial College London

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 .

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-06-01
• Study First Submitted: 2018-07-31
• Study First Submitted QC: 2018-07-31
• Study First Posted: 2018-08-06
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-13
• Last Update Posted: 2019-08-15
• Primary Completion: 2021-04-02
• Study Completion: 2021-04-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Osteocalcin	Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.	Assesses bone health of each group by comparing total osteocalcin and undercarboxylated osterocalcin

Secondary Outcome Measures

Name	Time	Method
Heart Rate	Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.	recording observations- heart rate
Glucose	Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.	measuring glucose
Blood pressure	Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.	recording observations- blood pressure
Lipid profile (Total cholesterol, HDL, LDL and triglycerides)	Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.	measuring biochemical indicators of cardiovascular risk: total cholesterol, HDL, LDL and triglycerides
High sensitivity CRP	Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.	measuring biochemical indicators of cardiovascular risk: high sensitivity CRP
Infection rates and severity	Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.	assessed by completion of the German National Cohort Questionnaire (GNCQ), questionnaires will cover socio-economic and socio-demographic factors, medical history, use of medications and health care, lifestyle factors, and questions related to environmental and occupational factors
Wellbeing	Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.	the short form health survey-36 (SF-36)
Waist-Hip circumference	Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.	recording observations- Waist-Hip circumference ratios
HbA1c	Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.	measuring HbA1c
P1NP	Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.	Assesses bone health of each group by comparing P1NP
NTX	Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.	Assesses bone health of each group by comparing NTX

Trial Locations

Locations (1)

Imperial College Healthcare NHS Trust; 🇬🇧 London, United Kingdom