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

Adrenal Insufficiency Clinical Trial

— OMNI-AID  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03615859
• Other study ID #: 18HH4425
• Secondary ID: 21675718/LO/0069
• Status: Recruiting
• Start date: June 1, 2018
• Est. completion date: April 2, 2021

Study information

• Verified date: August 2019
• Source: Imperial College London
• Contact: Sirazum Choudhury, MBBS MRCP
• Phone: 07555717544
• Email: steroids[@]imperial.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 2, 2021
• Est. primary completion date: April 2, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adrenal Insufficiency

Locations

Country	Name	City	State
United Kingdom	Imperial College Healthcare NHS Trust	London

Sponsors (2)

Lead Sponsor	Collaborator
Imperial College London	National Institute for Health Research, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	P1NP	Assesses bone health of each group by comparing P1NP	Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.
Secondary	NTX	Assesses bone health of each group by comparing NTX	Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.
Secondary	Heart Rate	recording observations- heart rate	Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.
Secondary	Blood pressure	recording observations- blood pressure	Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.
Secondary	Waist-Hip circumference	recording observations- Waist-Hip circumference ratios	Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.
Secondary	Lipid profile (Total cholesterol, HDL, LDL and triglycerides)	measuring biochemical indicators of cardiovascular risk: 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.
Secondary	High sensitivity CRP	measuring biochemical indicators of cardiovascular risk: high sensitivity CRP	Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.
Secondary	Glucose	measuring glucose	Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.
Secondary	HbA1c	measuring HbA1c	Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.
Secondary	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	Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.
Secondary	Wellbeing	the short form health survey-36 (SF-36)	Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.