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

13. august 2019 opdateret af: Imperial College London

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.

Studieoversigt

Status

Ukendt

Betingelser

Detaljeret beskrivelse

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 .

Undersøgelsestype

Observationel

Tilmelding (Forventet)

100

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 85 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
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

Hvad måler undersøgelsen?

Primære resultatmål

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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
P1NP
Tidsramme: 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
Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.
NTX
Tidsramme: 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
Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.
Heart Rate
Tidsramme: Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.
recording observations- heart rate
Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.
Blood pressure
Tidsramme: Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.
recording observations- blood pressure
Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.
Waist-Hip circumference
Tidsramme: 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
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)
Tidsramme: 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
Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.
High sensitivity CRP
Tidsramme: 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
Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.
Glucose
Tidsramme: Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.
measuring glucose
Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.
HbA1c
Tidsramme: Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.
measuring HbA1c
Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.
Infection rates and severity
Tidsramme: 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
Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.
Wellbeing
Tidsramme: 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)
Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Imperial College London

Samarbejdspartnere

National Institute for Health Research, United Kingdom

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. juni 2018

Primær færdiggørelse (Forventet)

2. april 2021

Studieafslutning (Forventet)

2. april 2021

Datoer for studieregistrering

Først indsendt

31. juli 2018

Først indsendt, der opfyldte QC-kriterier

31. juli 2018

Først opslået (Faktiske)

6. august 2018

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. august 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. august 2019

Sidst verificeret

1. august 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 18HH4425
  • 216757 (Anden identifikator: IRAS ID)
  • 18/LO/0069 (Anden identifikator: REC reference number)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

There are currently no plans to share individual data with other researchers

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

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