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

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ClinicalTrials.gov Identifier: NCT03615859
Recruitment Status : Recruiting
First Posted : August 6, 2018
Last Update Posted : August 15, 2019
Sponsor:
Collaborator:
National Institute for Health Research, United Kingdom
Information provided by (Responsible Party):
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.

Condition or disease
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 .


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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Objective Markers and New Indicators in Adrenal Insufficiency Disease (OMNI-AID Study)
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : April 2, 2021
Estimated Study Completion Date : April 2, 2021

Resource links provided by the National Library of Medicine


Group/Cohort
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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. P1NP [ 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 P1NP

  2. NTX [ 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 NTX

  3. Heart Rate [ Time Frame: Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy. ]
    recording observations- heart rate

  4. Blood pressure [ Time Frame: Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy. ]
    recording observations- blood pressure

  5. Waist-Hip circumference [ Time Frame: 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

  6. 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. ]
    measuring biochemical indicators of cardiovascular risk: total cholesterol, HDL, LDL and triglycerides

  7. High sensitivity CRP [ Time Frame: 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

  8. Glucose [ Time Frame: Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy. ]
    measuring glucose

  9. HbA1c [ Time Frame: Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy. ]
    measuring HbA1c

  10. 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. ]
    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

  11. Wellbeing [ Time Frame: 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)


Biospecimen Retention:   Samples Without DNA
Serum, plasma, urine and peripheral blood mononuclear cells will be stored as part of this study


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03615859


Contacts
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Contact: Sirazum Choudhury, MBBS MRCP 07555717544 steroids@imperial.ac.uk

Locations
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United Kingdom
Imperial College Healthcare NHS Trust Recruiting
London, United Kingdom, W12 8RF
Contact: Sirazum Choudhury, MBBS BSc    07555717544    steroids@imperial.ac.uk   
Sponsors and Collaborators
Imperial College London
National Institute for Health Research, United Kingdom
Investigators
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Principal Investigator: Karim Meeran, MBBS BSc MD Imperial College London

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Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT03615859     History of Changes
Other Study ID Numbers: 18HH4425
216757 ( Other Identifier: IRAS ID )
18/LO/0069 ( Other Identifier: REC reference number )
First Posted: August 6, 2018    Key Record Dates
Last Update Posted: August 15, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There are currently no plans to share individual data with other researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Imperial College London:
Glucocorticoids
Hydrocortisone
Prednisolone
Additional relevant MeSH terms:
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Adrenal Insufficiency
Adrenal Gland Diseases
Endocrine System Diseases
Prednisolone
Methylprednisolone Acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone acetate
Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Epinephrine
Racepinephrine
Prednisolone hemisuccinate
Prednisolone phosphate
Epinephryl borate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents