Adrenal InsufficiencyOMNI-AIDNCT03615859
Objective Markers and New Indicators in AI Disease (OMNI-AID Study)
An observational study of Adrenal Insufficiency, run by Imperial College London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Adrenal Insufficiency
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jun 2018to 2 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Imperial College Healthcare NHS Trust
London, W12 8RF
Sirazum Choudhury, MBBS BSc, 07555717544, steroids@imperial.ac.uk
About this study
Official title: Objective Markers and New Indicators in Adrenal Insufficiency Disease (OMNI-AID Study)
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.
Read the 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
- Keywords
- Glucocorticoids, Hydrocortisone, Prednisolone
- Medical subject headings
- Adrenal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Osteocalcin
Assesses bone health of each group by comparing total osteocalcin and undercarboxylated osterocalcin
Measured: Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.
Secondary outcomes (11)
P1NP
Assesses bone health of each group by comparing P1NP
Measured: Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.
NTX
Assesses bone health of each group by comparing NTX
Measured: Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.
Heart Rate
recording observations- heart rate
Measured: Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.
Blood pressure
recording observations- blood pressure
Measured: Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.
Waist-Hip circumference
recording observations- Waist-Hip circumference ratios
Measured: Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.
Lipid profile (Total cholesterol, HDL, LDL and triglycerides)
measuring biochemical indicators of cardiovascular risk: total cholesterol, HDL, LDL and triglycerides
Measured: Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.
High sensitivity CRP
measuring biochemical indicators of cardiovascular risk: high sensitivity CRP
Measured: Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.
Glucose
measuring glucose
Measured: Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.
HbA1c
measuring HbA1c
Measured: Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.
Infection rates and severity
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
Measured: Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.
Wellbeing
the short form health survey-36 (SF-36)
Measured: Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2018
- Study start1 Jun 2018
- Primary completion2 Apr 2021 (estimated)
- Study completion2 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adrenal InsufficiencyStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Karim Meeran, MBBS BSc MD, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03615859
- Sponsor's protocol ID
- 18HH4425
- Other IDs
- 216757, 18/LO/0069
- Acronym
- OMNI-AID
- Status last verified
- Aug 2019
- First submitted
- 31 Jul 2018
- Last updated
- 15 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are currently no plans to share individual data with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Objective Markers and New Indicators in Adrenal Insufficiency Disease (OMNI-AID Study)
- ClinicalTrials.gov ID
- NCT03615859
- Acronym / sponsor ID
- OMNI-AID / 18HH4425
- Conditions
- Adrenal Insufficiency
- Keywords
- Glucocorticoids, Hydrocortisone, Prednisolone
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 2 Apr 2021 (estimated)
- Study completion
- 2 Apr 2021 (estimated)
- First posted
- 6 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Osteocalcin
Time frame: 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
11 secondary outcomes
P1NP
Time frame: Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.
NTX
Time frame: Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.
Heart Rate
Time frame: Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.
Blood pressure
Time frame: Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.
Waist-Hip circumference
Time frame: Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.
Lipid profile (Total cholesterol, HDL, LDL and triglycerides)
Time frame: Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.
High sensitivity CRP
Time frame: Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.
Glucose
Time frame: Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.
HbA1c
Time frame: Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.
Infection rates and severity
Time frame: Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.
Wellbeing
Time frame: Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2019.
- Individual participant dataSharing planned: No. There are currently no plans to share individual data with other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karim Meeran, MBBS BSc MD principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adrenal Insufficiency, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sirazum Choudhury, MBBS MRCP (07555717544, steroids@imperial.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Osteocalcin (time frame: Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2019.